Clinical Trial Manager Resume Samples

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C Emmerich

Christop

Emmerich

6498 Frances Neck

Philadelphia

+1 (555) 388 0551

6498 Frances Neck

Philadelphia

Phone

p +1 (555) 388 0551

Experience Experience

Detroit, MI

Clinical Trial Manager

Detroit, MI

Torp-Bogan

Detroit, MI

Clinical Trial Manager

In conjunction with data management, assist with eDC development, preparation and/or review of data listings, issue and query resolution
Manages junior staff i.e.: CRAs / CRA IIs / CTA’s performing site management efforts
Provides clinical input for new product development, post market surveillance, recertification and business development
Develops and fosters positive working relationships with colleagues, development and service partners
Responsible for the training, performance management, and development of clinical staff
Development/management of vendor scope of work (SOW) per contract, quality, and budget
Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met

Philadelphia, PA

Clinical Trial Manager, Oncology

Philadelphia, PA

Langworth Group

Philadelphia, PA

Clinical Trial Manager, Oncology

Develop site/monitoring tools and training materials
Assist PM with preparation of information for inclusion in monthly report to client
Delivering the project according to the quality management plan
Managing operational aspects of projects, risk management plans, and representing clinical delivery with the customer
Assist PM in identifying and generating changes in scope and notify client of potential changes in scope
Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions
Define the scope of work with the client and clinical monitoring team

present

Houston, TX

Senior Clinical Trial Manager

Houston, TX

Gusikowski and Sons

present

Houston, TX

Senior Clinical Trial Manager

present

Set-up country budgets and monitor actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend
Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level
Project Management
Act as the primary contact person for the local teams within GCO. Establish and maintain excellent working relationships with internal stakeholders, including Local Trial Managers. Demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledge
Oversight of clinical monitoring quality and adherence to established processes and plans
Ensure investigational studies of Avid’s molecular imaging agents, adhere to FDA regulations, ICH GCP guidelines and Avid’s internal SOPs
Manage all components of clinical trials from protocol inception through CSR completion; including but not limited to staffing; writing and implementing protocols; site selection; designing CRF; monitoring plans and training site staff, internal staff and monitors on protocol specific procedures

Education Education

Bachelor’s Degree in Life Sciences

California State University, Los Angeles

Bachelor’s Degree in Life Sciences

Skills Skills

Working knowledge of ICH guidelines, Good Clinical Practices, HIPAA and applicable regulations, and guidelines related to the clinical trials
Excellent communication ability and skills for interacting among internal & external customer, especially in English
Agility: Able to quickly adapt to study changes. Communicates and implements changes in a positive manner
Demonstrated ability to identify problems, perform basic root cause analyses, and propose effective solutions
Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
Excellent oral and written skills and ability to effectively apply these skills
A strong communicator with excellent verbal and written communication skills
Experience managing Clinical Research Organizations (CROs), central laboratories, and other vendors highly desirable
Expert knowledge of relevant regulations e.g. ICH/Good Clinical Practices, FDA guidelines, etc
Excellent interpersonal skills and problem solving ability

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Clinical Trial Manager Resume Examples & Samples

7+ years in Pharmaceutical/biotech/medical device industry
5 years of experience with clinical trials phases 2-4
CRO
SOPs
CRF/EDC
Bilingual in English and Japanese
Ability/willingness to travel to Japan (if necessary)

Clinical Trial Manager Resume Examples & Samples

Bachelor Degree in business or science area with 4+ years pharmaceutical/biotechnology industry experience in clinical research, clinical operations or medical affairs is required
Prior experience working with Investigator Sponsored Trials and/or regulatory reporting within the pharmaceutical industry is preferred
Exceptional project management, including managing multiple complex projects from start to completion
Knowledge of the regulatory requirements for NDA ARs, including knowledge of pharmaceutical clinical trial process and AR documentation requirements
Demonstrated functional knowledge of Good Clinical Practices, Corporate policies and standard operating procedures as well as knowledge of applicable external regulatory requirements and guidelines
Experience in managing budgets and forecasts, as relate to clinical trials
Demonstrated superb organizational, time management and communication skills (verbal and written)
Demonstrated experience working on multiple projects simultaneously with significant attention to detail
Strong interpersonal skills with the ability to interact with all levels of the organization
Strong problem-solving, follow-through and decision-making skills for assigned programs with minimal supervision
Proven ability to work both independently and in a team setting, and to meet set goals by managing own timelines
Strong skills in Excel, and the ability to work with databases, e-rooms, and clinicaltrials.gov, etc. in an electronic environment

Clinical Trial Manager Resume Examples & Samples

Demonstrated success in a managerial capacity
Familiarity with ICH/GCP and regulatory guidelines/directives
Demonstrated financial budgeting and forecasting skills

Clinical Trial Manager Resume Examples & Samples

Bachelor's Degree or equivalent qualification in life science / healthcare
On-site monitoring experience
Strong leadership and communication skills
Working experience in a global team setting
Strong team player
CRA role experience
Previous experience working on clinical trials in an outsourced model

Clinical Trial Manager Resume Examples & Samples

Oversees study timelines, clinical trial budgets, coordinates development of study plans, CRF's and other study reports
Reviews and approves monitoring reports as appropriate
. Participates in review of clinical trial data
. Reviews regulatory documentation for accuracy and completeness
Provides updates to annual reports, IB, etc. from the clinical trial prospective
Responsible for Investigator Meeting coordination and participation
Escalates issues as appropriate to Sr. Clinical Trail Manager14. Acts on constructive feedback to improve performance

Clinical Trial Manager Resume Examples & Samples

Ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones as leader of the Study Management Team (SMT). This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned by the GTL
Create appropriate trial-specific training materials and requirements, making them available to the GCO site study staff and delivering training as needed. Responsible for the set-up and coordination of Investigator Meetings, if applicable, in close collaboration GCO staff as well as GTL
Ensure compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the SMT operates in a constant state of inspection-readiness. Work with Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools

Senior Clinical Trial Manager Resume Examples & Samples

Set-up country budgets and monitor actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend
Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level
Create and update study-specific documents such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, country and site feasibility related documents. Provide input into cross functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan
Create appropriate trial-specific training materials and requirements, making them available to the GCO site study staff and delivering training as needed. Responsible for the set-up and coordination of Investigator Meetings, if applicable, in close collaboration with GCO staff as well as GTL
Act as the primary contact person for the local teams within GCO. Establish and maintain excellent working relationships with internal stakeholders, including Local Trial Managers. Demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledge
Provides updates to all SMT as well as Trial Team members on the deliverable status. Ensure required reports are generated and available for real time tracking of trial status. Manage timely and accurate documentation, communication of study progress and issue escalation

Clinical Trial Manager, Immunology Resume Examples & Samples

Ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones as leader of the Study Management Team (SMT). Support GTL in managing related CRO activities. This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned by the GTL
Can be involved in recruitment & coaching of more junior staff
Can act as a Subject Matter Expert
Minimum of 8 years clinical trial management experience in the pharmaceutical industry or CRO, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
Independent decision-making skills are essential to this role as are analytical skills and effectiveness in seeking solutions to issues
Effective leadership and delegation skills and proven ability to foster team productivity and cohesiveness. Computer literacy is also required

Senior Clinical Trial Manager Resume Examples & Samples

Minimum of 6 years clinical trial management experience in the pharmaceutical industry or CRO, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
Requires clinical research operational knowledge, strong project planning/management and effective communication skills, Should be flexible and have experience and ability in managing global or regional teams in a virtual environment. Proven track record in successfully managing trials from start-up to database lock. Experience with supervision of CROs/vendors is preferred
Specific therapeutic area experience may be required depending on the position
Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues
Effective leadership skills and proven ability to foster team productivity and cohesiveness. Computer literacy is also required
Willing to travel up to 20% of time.Clinical Trial Coordination

Clinical Trial Manager Resume Examples & Samples

This Clinical Trial Manager will be responsible for clinical trial management within the Clinical R&D Operations CoE, as well as fostering strong, productive relationships with colleagues across the organization
Serves as the liaison with the Clinical R&D Franchise for projects under his/her responsibility
Serve as a Clinical Trials Manager within the Clinical R&D Operations CoE group to execute company sponsored clinical trials for the Medical Device Franchises
Manage all operational activities of assigned clinical trials/programs within the Clinical R&D Operations group
Serves as a member of the clinical trial/study/program core team and may serve as the back-up liaison to the Clinical R&D Franchise and Clinical R&D BSDM for projects/trials/programs under his/her responsibility
Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed
May be involved in other tasks to support Clinical R&D Operations and R&D Clinical Franchise as needed
Plan, track and manage assigned projects budgets to ensure adherence to business plans
Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
Provide primary leadership within a clinical trial, ensuring that each team member has a well-defined set of activities and objectives specific to their role and responsibilities within the context of their business focus
Manage and mentor Clinical Trial Leaders/Sr. Clinical Trial Leaders/Staff Clinical Trial Leaders, as applicable
Responsible for the training, performance management, and development of clinical staff
8 years of relevant experience or equivalent required
Minimum of 2 years people management
Significant previous experience in clinical project leadership across multiple studies/programs required
Experience with budget planning, tracking and control required
Requires knowledge of Good Clinical Practices
Knowledge and application of regulations and standards applied in clinical areas/regions is required
Strong project management skills with ability to handle multiple projects
10 % travel required
IDE study experience is required.Clinical Trial Coordination

Senior Clinical Trial Manager, Neuroscience Resume Examples & Samples

Ensure regional/global clinical operations deliverables against project timelines. Support GTL in managing global vendors involved in site facing work; including country & site feasibility, site selection, trial set-up, study execution and set up and closure activities as assigned
Create and maintain study-specific documents such as Monitoring Guidelines, Informed Consent Form, Blinding Plan, country and site feasibility related documents
Create , communicate and deliver trial training materials to the GCO site study staff
You will act as the primary contact person for the local teams. Establishing and maintaining excellent working relationships with internal partners, including Local Trial Managers. Demonstrate deep knowledge of protocol and procedures
Provide real time deliverable status updates to all SMT, and Trial Team members. Lead timely and accurate documentation, communication of study progress and issue reports
Experience in Neuroscience Therapeutic Area, specifically within psychology/psychiatric trials
Phase III trial experience
Solutions focused
Your leadership and delegation skills with ability to champion team productivity and cohesiveness is desired

Senior Clinical Trial Manager, Hematology Resume Examples & Samples

Ensure regional/global clinical operations deliverables against project timelines. Support GTL in oversight of global vendors involved in site facing work; including country & site feasibility, site selection, trial set-up, study execution and closure activities as assigned
Establish country budgets and monitor against forecasts for Out of Pocket Expenses, and review assigned vendor invoices/spend
Build and maintain study-specific documents such as Monitoring Guidelines, Informed Consent Form, Blinding Plan, country and site feasibility related documents
Craft , communicate and deliver trial training materials to the GCO site study staff
You will act as the primary contact person for the local teams; establishing and maintaining excellent working relationships with internal partners, including Local Trial Managers. Demonstrate deep knowledge of protocol and procedures
Lead compliance activities in line with global health authority regulations/guidelines. Participate in and lead preparation for, the conduct of Health Authority inspections and internal QA audits. You will ensure a constant state of inspection-readiness
Experience in Hematology- Oncology Therapeutic Area
Consistent record of successfully executing trials from start-up to database lock is preferred as is prior supervision of CROs/vendors
Independent decision-making and analytical skills

Clinical Trial Manager Resume Examples & Samples

Lead or Participate in GCDO initiatives as assigned
BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy)
Requires clinical research operational knowledge, strong project planning/management and excellent communication skills, Should be flexible and have experience and ability in managing global or regional teams in a virtual environment. Proven track record in successfully managing trials from start-up to database lock. Experience with supervision of CROs/vendors is preferred
Immunology therapeutic area experience may is preferred
Preferred: experienced in global study recruitment, global study site and country management, inclusive of study site quality management and oversight
Preferred: experienced in vendor management and oversight, particularly the vendor's activities towards site and country set up and management throughout a clinical trial
Willing to travel up to 20% of time

Clinical Trial Manager Resume Examples & Samples

Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection and communication with clinical trial sites regarding all logistics including contract agreements, support materials and training
Provides on-site clinical oversight and management for clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during use of the company’s medical devices during clinical investigations and post-market studies
Communicates with clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up and close out study visits to ensure compliance with protocols and GCP requirements
Collaborates on clinical data processing in accordance with departmental SOPs and guidelines
Verifies, reviews and tracks CRFs and generates Data Clarification Forms (DCFs) for all missing or inaccurate data; ensure that data changes are properly implemented and captured in the database or data system
Assists in the evaluation and analysis of clinical trial data to facilitate completion of clinical trial reporting requirements, including report writing, clinical photo-documentation, FDA and manuscript submissions
Assists in tracking study specific payments
Provides operational or work flow support to assure that departmental and cross functional systems and procedures are efficiently and correctly completed
Collaborates on project teams, primarily with the Clinic, Research and Development, Advanced Development, Marketing, Regulatory and Quality/Compliance
Leads or collaborates on technical writing projects which include white papers, abstracts, manuscripts, and literature reviews
Liaison between internal and external stakeholders to facilitate cooperation of others
Conducts presentations of clinical information concerning specific projects
Works on projects of moderate-to-high degree of difficulty in which analysis of situation or data requires review of identifiable clinical factors and in which scientific and clinical perspectives should be incorporated
Bachelor’s degree in a health profession or science. Advanced degree preferred
At least 5 years of on-going clinical trials experience in the medical device industry. Experience in the cosmetic/aesthetic field is preferred
Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements
Ability to effectively work independently
Excellent verbal and written communication skills plus computer proficiency (Word, Excel, Outlook) and data management experience
10%-30% travel required

Global Clinical Trial Manager Resume Examples & Samples

BA/BS/BSc or RN
Broad experience working in life sciences or medically related field, including general biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company)
Previous management experience of direct reports

Clinical Trial Manager Resume Examples & Samples

Develop and monitor project schedule and scope to ensure both remain on track; implement and follow pre-approved procedures for any deviations
Develop spreadsheets for clinical budgets and timelines
Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to BERG requirements
Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs
Prepare and actively participate as operational lead in internal Project Review meetings. Depending on size and scope of project, this job duty may be performed in collaboration with a senior member of the Clinical Operations team
Create required project plans; implement and monitor progress against project plans and revise as necessary; review clinical protocols, CRF’s, study reports, and informed consent forms
Ensure that clinical research is cost effective by analyzing internal and external costs, resource utilization and performance data
Negotiate & establish contracts and budgets with external clinical sites
Develop training programs for internal and external resources
Ensure work is performed in accordance with industry standards, federal and state regulations, accreditation standards and Berg Pharma mission and core values
Participate in global research activities such as creating IBs, INDs, study document filing
Audits of vendors (Clinical, CMC)
Participate in quality and/or process improvement activities
Comply with all safety and work rules, policies and procedures
Perform audits of work on a regular basis; initiate and implement corrective actions with results
Prepare reports, documents, statistical surveys and other such data as required
Requires a BS degree in a scientific discipline with a 5+ years of clinical research experience in the pharmaceutical industry and/or CRO, with a strong preference for experience in small oncology biotech
Excellent MS Office applications skills, especially well-versed in the development and use of Excel spreadsheets
Strong understanding of regulatory requirements
Ability to communicate effectively with physicians, fellow employees, patients, guests, contractors and vendors
Strong problem-solving skills and flexibility in a growing organization

Senior Clinical Trial Manager Resume Examples & Samples

Strong study management expertise
Advanced project management skills with little assistance over time
Advanced knowledge of GCP/ICH and local guidelines, regulations and directives
Excellent oral and written skills and ability to effectively apply these skills

Principal Clinical Trial Manager Resume Examples & Samples

Strategic expert of program and study management
Expert knowledge Clinical Trial Process (CTP) and drug development process
Expert project management skills Expert knowledge of GCP/ICH and guidelines, regulations and directives
Expert in computer technical skills, competency for current level
Expert knowledge of clinical trial budgeting, forecasting, and financial management
Develops clinical program independently
Expert level cross functional awareness
Skills/Knowledge Required
Recognized as a technical Expert in the operational execution of the studies
Clinical trial project management skills
In depth knowledge of ICH/GCP, regulatory guidelines/directives, and clinical research processes
Disease/Therapeutic knowledge and expertise is highly desirable
Comprehensive expertise in drug development, including solid knowledge of interfaces and interdependencies of clinical development with other functions (e.g. nonclinical & pharmaceutical development, regulatory, commercial/marketing)
Solid Therapeutic Drug Development expertise for the assigned program
Understanding of cross-functional components of the operationalization of trials to integrate input from internal and external team members into the clinical operation strategy
Ability to lead a global, cross-functional virtual team
Ability to lead and drive program planning and delivery in collaboration with CRO partners
Proven problem-solving skills to prevent and overcome complex safety and compliance related issues during clinical program implementation and execution
Demonstrated success in using oral and written communication skills to influence, inform, or guide others
Solid computer skills – requirement of MS applications including (but not limited to) MS Project, Word, Excel
BA / BS, Advanced degree preferred
Degree in relevant discipline
Minimum of 10 years clinical research experience including all aspects of clinical trial planning and start up (including budget & resource planning), and in executing a wide range of clinical trial activities, from start up through final study report
At least 6 years clinical study management experience with
At least 4 years direct multinational study management experience
Minimum of 4 years experience in oversight of CRO study execution

Clinical Trial Manager Resume Examples & Samples

The contractor shall serve as the primary contact for clinical site personnel for operational activities and progress, including responding to issues and recommending corrective actions
The contractor shall participate in the design, writing, and review of all project-related documents including: budgets and proposals, change orders, protocols, informed consent, case report forms, statistical analysis plans, data management plans, and clinical study reports
The contractor shall track and assist in coordinating the monitoring of clinical sites including pre-study, site-initiation, interim, and close-out visits, as required
The contractor shall coordinate site reports and provide clinical trial status updates to the Government team lead for all sites as necessary
The contractor shall assist in monitoring regulatory review progress for all clinical sites, including but not limited to Scientific Review, IRB, and second level Department of Defense review, particularly tracking submission/approvals and continuing review reports
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer
Possess documented advanced training in GCPs as well as significant experience in clinical trial monitoring, including paper and Electronic Data Capture (EDC) studies
Position requires the ability to obtain secret clearance

Senior Clinical Trial Manager Resume Examples & Samples

Ensure investigational studies of Avid’s molecular imaging agents, adhere to FDA regulations, ICH GCP guidelines and Avid’s internal SOPs
Manage all components of clinical trials from protocol inception through CSR completion; including but not limited to staffing; writing and implementing protocols; site selection; designing CRF; monitoring plans and training site staff, internal staff and monitors on protocol specific procedures
Maintain project timelines during the planning, initiation, ongoing/active and study completion stages of clinical trials
Supervise the selection of appropriate investigational centers to expedite the conduct of clinical studies
Conduct site qualification to assess the qualifications and capabilities of potential sites and investigators and conduct site initiation visits
Manage the study budget
Manage clinical outsourcing process, vendor agreements including CRO, Central lab, ECG and electronic data capture as well as manage vendors with respect to contracted scope of work and budget
Support SOP development and implementation
Represent Avid in interactions with external thought leaders
Serve as liaison between clinical operations and other functional areas at Avid
BS or RN
A minimum of 7years of experience that includes a combination of managing external monitoring and in-house CRA workload and clinical trial management
Protocol writing, clinical study report writing
Strong project management skills with a track record of success
Strong CRO management skills with a track record of success
Strong knowledge of FDA regulations and ICH guidelines
Phase I-IV clinical trials experience, preferably with radiopharmaceuticals and/or central nervous system therapeutics
Experience managing global clinical trials
Ability to lead, plan and execute various activities with minimal supervision under aggressive study timelines
Excellent problem solver with outstanding attention to detail
Ability to manage multiple projects with competing priorities
Excellent communication skills, interpersonal, and teamwork skills

Clinical Trial Manager Resume Examples & Samples

Responsible for leading and supporting defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines under direction of the Clinical Program Manager (CPM) or Associate Director/ Director of Clinical Operations
Serve as a member of one or more cross-functional Study Execution Team(s) (SET) and may lead a SET under the direction of a CPM/AD/D
Under the direction of the CPM/AD/D, develop and facilitate RFPs for assigned vendors, review proposals and make award recommendations, participate in selection of CROs and vendors
Responsible for the day-to-day management of assigned vendors to ensure that project goals are achieved; organize and lead teleconferences with key vendor personnel, facilitate vendor activities and oversee adherence to scope of work and service agreement
Participate in developing and finalizing cross-functional SET deliverables such as clinical study protocols, CRFs, consent forms, study reference manuals, study reports, annual reports and other clinical documents
Manage study budget for assigned vendors; review vendor invoices against contract and work completed; identify and transparently communicate variances
Partner closely with CPM/AD/D, Clinical Development and CRO to identify and select clinical trial sites
May perform oversight and/or co-monitoring of clinical sites as required by the needs of project
Work with SET, external partners and sites to ensure that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled and otherwise ‘quality assured&#8217
Coordinate and participate in routine and final database lock listings review
Participate in implementation and oversight of study systems and including CTMS, TMF, EDC, IxRS, and sample management
May draft and implement assigned study management plans, including monitoring, vendor oversight, biosample management, TMF oversight, risk management, quality management and medical monitoring
Create, maintain and conduct ongoing quality review of the TMF to ensure files are properly maintained and up to date, archived and stored
Track key study metrics using tracking tools, providing timely and quality updates to the SET
Identify potential issues and risks, and propose potential resolutions
Develop strong working relationships and maintain effective communication with key internal and external stakeholders
Plan investigator meetings; develop content and present site training materials
Train vendors and team members on study protocol and processes
Participate in department process improvement initiative and system implementation
May review and revise SOPs, working practices and other infrastructure as directed
BS/BA in Life Science or related discipline
5+ years of experience in clinical and drug development
Global clinical trial and CRO management experience in oncology
Early-phase trial management experience preferred

Senior Clinical Trial Manager Resume Examples & Samples

Lead cross-functional Study Execution Team(s) (SET) and vendor efforts to ensure Five Prime clinical trials are initiated efficiently and completed on time
Provide operational expertise and partner with the SET to ensure that scientific objectives of the clinical studies are met
Partner closely with Clinical Development Team (CDT) and other functions to design and write clinical trial protocols
Lead the authoring and finalization of project and study related documents including IBs, informed consent forms, annual reports, and clinical study reports
Independently draft, review and implement study management plans and vendor oversight plans. Ensure CRO, vendors, and SET adhere to study plans
Lead the identification and selection of study CROs and vendors (e.g., CRO, IxRS, Central and Specialty labs), including negotiation of scope of work, budgets
Provide direction and oversight of CROs and vendors to ensure delivery against scope of work. Manage vendors to key performance indicators
Conduct study feasibility assessments; partnering with team and program lead on final country and site selection
Lead investigator meeting planning and execution. Ensure sites, vendors and internal staff are trained on study protocol and processes
Work with external partners and sites to ensure that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled, and of high quality
Participate in the ongoing and final review of study data and assessment of the impact of this data to the study and program
Proactively identify and mitigate study-specific risks. Effectively communicate study status, risks, and changes that may impact quality, timelines, and cost to internal and external stakeholders
Manage study budget and review of vendor invoices against scope of work. Partner closely with the program lead to ensure accurate accruing of study costs and forecasting of study budget. Identify and communicate variances
Partner with Contracts department on the development of site budget and CTA templates and negotiations with sites
Partner with Data Management to design and develop of eCRFs. monitoring conventions, and edit checks. Oversee data discrepancy management and vendor or site retraining as needed
Oversee implementation of study systems (e.g., CTMS, eTMF, eCOA, IxRS)
Partner with Clinical Supply to forecast IMP and determine clinical trial supplies required for trial execution
Participate in and may lead department process improvement initiatives and system implementation
Review and provide input on cross functional SOPs, working practices and assist in the creation and improvement of department infrastructure as directed
Manage cross-functional Study Execution Team(s) (SET) and vendor efforts to ensure Five Prime clinical trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines
Partner with CPM/AD/D to develop and implement operational strategy for assigned clinical trials including country selection, site selection, vendor selection, study timelines and budget
Write or contribute to preparation and finalization of project and study related documents including investigator brochure, protocols, informed consent forms, case record forms, clinical study reports, and study management plans
Partner with SET members, vendors and sites to ensure the timely delivery of high quality clinical data; coordinate and perform routine and final database lock listings review
Participate in selection and perform ongoing service provider management and oversight of study vendors (e.g., CRO, IxRS, Central and Specialty labs), including negotiation of scope of work, budgets, performance management, risk management and issue resolution
Provide oversight of site management through review of CRO monitoring visit reports and Key Performance Indicators
Manage study budget. Partner closely with CPM/AD/D to ensure accurate accruing of study costs and forecasting of study budget. Review vendor invoices against contract and work completed; identify and transparently communicate variances. Oversee reconciliation of site payments against patient visits to ensure accurate payments
Partner with Contracts department on the development of site budget and CTA templates and negotiations with sites, until execution
Manage clinical trial supplies required for trial execution
Assist in the training of CROs, CRAs, vendors and site staff on study protocol and processes
Support the management and execution of study-related meetings by developing and presenting study materials (e.g., investigators, CRA training meetings)

Clinical Trial Manager Resume Examples & Samples

Contribute to the development and maintenance of cross functional project management plans
Collaborate with Business Development (BD) to ensure timely completion of change orders
Track Clinical Operations project deliverables using appropriate tools
University/Bachelor’s Degree in medicine, science or equivalent degree/experience
Previous working experience within the clinical trial management field
Experience in Late Phase monitoring
Thorough knowledge of ICH GCP
Some knowledge of project management processes and tools
Due to the nature of this position it may be required for the employee to travel approx 25%. Therefore, dependent on the employee’s location, the employee may be required to possess a valid Driver’s license

Clinical Trial Manager Resume Examples & Samples

Plans and assists study start-up activities such as, the CRO pre-site selection, CRO Contract and Budget Process, creation of Monitoring Plan, Laboratory Manual, Pharmacy Manual, Site Initiation Presentations, CRF Completion Guidelines, and various forms, study tracking and management documents
Oversight of CRO, including project tracking of subject and site information, and generation of metrics and updates for senior management
Management and oversight of clinical study files/documents within electronic and/or paper Trial Master File
As required, participates in the development, review and implementation of departmental SOPs and processes
Reviews and approves (as required) site study documents (informed consent template and study tools/worksheets), investigator contracts/budgets, and site payments
Assists with protocol, IB, and CRF development
Performs or oversees CRO pre-site selection and site initiation, as well as interim, close-out, and co-monitoring visits to ensure compliance with protocol and regulatory requirements and to assure good site performance
Reviews and manages monitoring reports and follow-up within project-specific timelines
Develops and revises RFPs, SOWs, study and site budgets/contracts including performance metrics
Manage direct reports (Clinical Trial Assistant’s (CTAs) Clinical Research Associates (CRA’s)
Recommends and implements innovative process ideas to impact clinical trials management and success
As required, Participates in the development, review and implementation of departmental SOPs and processes
Bachelor’s level degree in life sciences, pharmacy or nursing; RN preferred
Prior related clinical trial management experience with a minimum of 1 year supervisory experience preferred
Oncology experience preferred with Global experience a plus
Experience managing outside vendors, e.g., CROs and labs
Able to provide clinical operations expertise to clinical development in a specified product area or project
Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment
Knowledge of clinical research operations, including interpretation and implementation of cGCP, FDA regulations, and ICH guidelines is required. Global (Ex-US) regulatory experience a plus
Able to deal with time demands, incomplete information or unexpected events
Knowledge of the principles and practices of basic computer applications used in general office setting, including word processing, spreadsheet, database management, presentation software, and internet search engines
Advanced capabilities with Microsoft PowerPoint, Word, Excel, and Project desired
Basic math and standard business level English grammar and usage
Able to travel approximately 20% overnight (50% or greater during peak times)

Clinical Trial Manager Resume Examples & Samples

Develops and coordinates clinical trial and operational activities and manages their execution to ensure completion according to project timelines and budget
Coordinates and leads cross-functional teams, such as the clinical sub-teams that include representatives from multiple internal departments (eg, Medical Science, Regulatory Affairs, Data Management). Mayparticipate in project core team meetings. Provides regular and timely input to the assigned Project Manager
Develops clinical trial timelines, enrollment projections, documents and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
Responsible for ensuring the development and updating of cost estimates at the study and project level
Partners with the Clinical Services Partnership (CSP) team in developing complete clinical trial external cost estimates (sites and vendors) and maintains responsibility for the management of the clinical trial budget
Partners with the Clinical Trial Associate I/II to ensure the TMF is developed, maintained, and archived
Minimum of 5 years of directly related experience required; clinical research experience strongly preferred
Previous monitoring, study coordination, data management and/or clinical project management experience including vendor/CRO management is required
Experience with opioid analgesics late stage trials a plus
Knowledge of cGCP, ICH and FDA regulatory requirements
Travel as needed to resolve field issues, provide training, and meet with partners and CROs
Proficient computer skills with Microsoft Office software (Word, Excel, Project, PowerPoint and Outlook)

Clinical Trial Manager Resume Examples & Samples

Previous monitoring, study coordination, clinical project management experience is required
Experience with Hospital based products, rare disease and/or drug device combination studies in late stage trials is plus
Global trial experience highly desirable
Travel up to 35% to resolve field issues, provide training, and meet with partners and CROs

Clinical Trial Manager Resume Examples & Samples

Develops full suite of planning tools for each clinical trial, including Study Oversight Plan, Clinical Monitoring Plan, enrollment plan, communication plan, contingency plan, start up and closure plan
Tracks and reports study metrics (site and patient status, CRF completion, query status) against plan
Develops site budget in collaboration with Clinical Business Operation Manager
Develops and implements study-specific monitoring and site training tools, and oversees training
Provides Finance with activity forecasts to allow for appropriate accrual
Acts as primary contact for all study activities
BS or Nursing degree required. A scientific discipline is strongly preferred
Five-year of experience with clinical trials as a CRA or related discipline
Strong organizational, planning and follow-through skills
Ability to work well under pressure and with tight schedules
Excellent language and grammar skills, ability to write clearly and concisely

Clinical Trial Manager Temp Resume Examples & Samples

A Bachelor’s degree in a scientific or health-related field is required
Minimum of four years of general clinical research experience, including on-site monitoring experience
Must have a minimum of two of experience in managing clinical trials at a pharmaceutical/biotech company or CRO
Advanced understanding of GCPs, FDA regulations and ICH guidelines is required
Therapeutic experience and knowledge in neurological and cardiovascular preferred, but not required
Ability to manage both day-to-day operations as well as project work in a fast paced environment
Excellent project management and teamwork skills

Clinical Trial Manager Resume Examples & Samples

Proficiency with computer systems and Microsoft Office Suite (Outlook, Word, Power Point, and Excel) required
Attention to detail and demonstration of quick follow-up to study needs, commits to quality
Interpersonal skills and clear oral and written communication skills. Uses correct grammar, syntax, and format
Demonstrated adaptability, handles day to day work challenges confidently, is willing and able to adjust to multiple demands, shifting priorities; shows resilience in the face of challenges, demonstrates flexibility
Shows work commitment: sets high standards of performance; pursues aggressive goals and works efficiently to achieve them

Senior Clinical Trial Manager Resume Examples & Samples

Establish enrollment success factors and ensure delivery of projected commitments across the regions at the clinical trial level
Provide input into cross functional documents i.e. Safety related documents, Protocol Deviations and Issue management processes
Provide real time deliverable status updates to SMT and Trial team members. Lead timely and accurate documentation, communication of study progress and issue reports
Experience in Infectious Disease/ Vaccine Therapeutic Area
Phase II & III trial experience
Your leadership and delegation skill with ability to champion team productivity and cohesiveness is desired

Clinical Trial Manager Resume Examples & Samples

Manages all clinical operational and quality aspects of allocated studies in compliance with ICH GCP
In conjunction with the project manager prepares, organizes and presents at Investigator Meetings
Provides regular status updates to PM for client reports
Ensures regular project review, using PPD tracking & management tools, implementing appropriate recovery actions to ensure project timelines are met
Manages CRF collection and query resolution process
Significant clinical research experience (comparable to 3+ years) in all phases of study life cycle, including start up, interim, close out and field monitoring
CRO/Pharma management experience (preferred)
Valid Driver's License and Passport

Clinical Trial Manager Resume Examples & Samples

As a Manager, you would be expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
University/Bachelor’s Degree in medicine, science or equivalent degree. 1 to 2 years of CTM experience in a CRO or Pharmaceutical Company
A satisfactory progression of monitoring experience with previous experience in leadership and/or management activities
Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials
Due to the nature of this position it may be required for the employee to travel approx 25%

Associate Clinical Trial Manager Resume Examples & Samples

Minimum 2 years clinical study management experience preferred or equivalent
Solid project management skills
KKnowledge of ICH GCP and local guidelines, regulations and directives
Good oral and written skills and ability to effectively apply these skills
Solid computer technical skills
Solid knowledge of budgets, Finance and clinical trials
Develops budgets under supervision
Solid cross functional awareness

Senior Clinical Trial Manager Resume Examples & Samples

Manage regional or global Medical Affairs interventional, non-interventional clinical trials, name patient /compassionate use programs and/or investigators initiated studies from project planning, feasibility through to database lock, site closure and study report within quality guidelines, timelines and budget
Work with the appropriate vendors and internal stakeholders to make sure study is started up, recruited and completed on time in accordance with the protocol and all applicable regulations
Pro-actively manage patient recruitment and retention and develop contingency plans at a regional/global level
Measure progress against goals to achieve clinical research targets
Manage the budget associated with the conduct of the trials
Ensure timely and accurate documentation, communication and follow-up of study progress and issues, including vendor oversight
Ensure that required reports are generated within organizational guidelines
Interact with multifunctional teams within and outside of GCO. e.g. regional and country medical affair team, GDO functions including GCO-TCSM, IDS, B&P and Medical writing, Quality Management & Training group, Vendor Management, planning group, CSU, and GPS, GCQA, Regulatory affair, BRM, finance and legal
At least 6-8 years experience in clinical trials with a pharmaceutical company and/or a CRO
Have been involved with regional projects/initiatives and understand the complexity of working across multiple geographies
Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations, in-depth knowledge of Medical Affairs or global/multi-country clinical operations, full understanding on all logistical aspects when running interventional and/or non-interventional clinical trials regionally, and good understanding on the therapeutic areas where J&J is involved
Strong ability to handle multiple tasks and priorities
Excellent written and verbal communication in English
Highly motivated, energetic, proactive, enthusiastic and an independent thinker, while being an excellent team player
Results driven and innovative, take initiative,
Have excellent problem solving and decision making skills
Excellent communicator, with excellent interpersonal skills and diplomacy
Cross-cultural savvyClinical Trial Coordination

Clinical Trial Manager / Senior Manager Resume Examples & Samples

Coordinates and leads cross-functional teams, such as the clinical sub-teams that include representatives from multiple internal departments (eg, Medical Science, Regulatory Affairs, Data Management). May participate in project core team meetings. Provides regular and timely input to the assigned Project Manager
Reviews and contributes to protocols, amendments, case report forms (CRFs), and clinical study reports (CSRs). Develops informed consent documents
Coordinates the qualification and selection of investigative sites, plans for and presents at Investigator Meetings, develops other site training materials
Partners with the CSP in identifying appropriate vendors for possible selection. Participates in the vendor selection process, including input and review of the draft RFP, review of returned RFPs, bid defense meetings, audits, and final vendor selection
Manages vendor and CRO activities, and tracks internal and external (CRO/vendor) project deliverables to ensure they remain within the timeline and budget
Ensures CRAs assigned to a project are trained on the protocol and relevant SOPs, reviews monitoring visit reports, accompanies CRAs on site visits, and initiates/follows up/tracks significant or relevant project issues at investigative sites
Ensures study execution compliance with GCP/ICH and any other regulatory requirements and works cooperatively with Quality Assurance with respect to site audits
Develops trial monitoring plans and tracks and reports compliance
Stays current with regulations and industry trends and provides input into processes to ensure adherence to regulations and meet best practice standards
Actively communicates project issues and identifies emerging risks, then works with internal governance team of director-level (and above) multidisciplinary drug development professionals to help resolve project challenges
Other duties as assigned with or without accommodation
CTM Minimum of 5 years of directly related experience required; clinical research experience strongly preferred
Senior Clinical Trial Manager 8 years of directly related experience required; clinical research experience strongly preferred
Must have previous CRO/vendor management experience
Solid project management, analytical and problem solving skills

Clinical Trial Manager Resume Examples & Samples

Supports the Clinical Program Manager by providing study status updates, and informs and as needed escalates issues; Provides operational support as needed at various meeting interactions with, as example, advisors or Partners
Accountable for accurate and timely entry of study information (e.g. design, results) into ClinicalTrials.Gov in collaboration with RAs and Clinical Affairs
Accountable for oversight of Clinical Trial Manager activities
In collaboration with key stakeholders, responsible for supporting the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness
Accountable for the management and maintenance of the study TMF
Accountable for leading, and managing the process for the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with the study team, CRO Management, Clinical Affairs and key stakeholders
Minimum of 5 years of pharmaceuticals/biotech experience
Minimum of 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials
Extensive experience in the operational and scientific/medical aspects of clinical development
Critical thinking skills, and ability to identify potential issues and solutions, across clinical development programs
Strong project management, leadership and mediation skills within a matrix environment. Continuous improvement experience preferred
Ability to work across broad range of interfaces, and take broad perspective to harmonize processes and procedures
Demonstrated ability to develop and manage end to end study operational plan
Demonstrated ability to operationally execute and deliver a quality clinical trial
Proven leadership abilities and demonstrated experience directly working in multidisciplinary study teams
Demonstrated ability to execute within a matrix management model, ideally in pharmaceuticals/biotech
Timeline, budget and resource management experience required
Demonstrated experience in change management initiatives preferred
Program and project management experience preferred
International experience a plusSearch Jobs US

Senior Clinical Trial Manager Resume Examples & Samples

Responsible for managing assigned aspects of the operational study budget, timelines, and risk mitigation
Processes with input from key stakeholders
Responsible for supporting the management and maintenance of the study TMF
B.S. degree
Minimum of 3 to 5 years of pharmaceuticals/biotech experience
Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials
Process and system thinking, customer orientation, and ability to work in multidisciplinary study teams and to execute within a matrix management model, ideally in pharmaceuticals/biotech
Experience in execution of clinical research trials, including GCP and regulatory guideline knowledge and audit inspections
Knowledge and experience in clinical study budgeting including timeline and the application of clinical trial performance metrics
Demonstrated ability to support the development and management of various aspects of the end to end study operational plan
Demonstrated ability to support the operational execution and delivery of various aspects of a quality clinical trial
International experience a plus
Knowledge of drug development and FDA GCP/ICH regulatory guidelines
Proficiency with and ability to utilize software applications that support Clinical Operations: MS-Word, Excel, PowerPoint; Adobe Acrobat, EDC systems, etc
Clinical trial management system (CTMS) background is a plus
Strong ability to work within a matrixed organization, managing multiple tasks in a timely, budget conscious manner
Ability to identify and work with key stakeholders to deliver operational requirements
Ability to consistently operationalize abstract ideas.Search Jobs US

Clinical Trial Manager Resume Examples & Samples

Oversees the delivery of studies to ensure that they are completed on time, within budget and in compliance with SOPs, FDA and global regulations and ICH/GCP guidelines
Provides Clinical Operations leadership to CROs, other vendors, CRA team, internal study team, and Project Coordinators
Develops timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines
Responsible for developing and implementing robust contingency and issue management plans to solve complex issues that impact study or program milestones
Manages staff and provides technical advice to team members
Disseminates clinical study communications to all functional groups and leads study and team meetings
Interacts with clinical research investigators and sites
Interacts with Senior Management to report on progress of milestones
Organizes, attends, presents and provides training at investigator meetings
Assists or leads development and writing of study protocols, study plans, CRFs, informed consent forms, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA)
Travel required: up to 20%
BA/BS or higher degree
5-7 years’ experience in clinical study or program management, including study start-up, conduct, and close-out of trials (level determined by experience)
Solid technical knowledge of oncology therapeutic area strongly preferred
Experience managing Clinical Research Organizations (CROs), central laboratories, and other vendors highly desirable
International trial management experience desirable
Demonstrated ability to develop operational strategy for clinical studies, including development of timelines, communication plans, risk management/contingency plans and budgets
Line and matrix management experience preferred
Expert knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations
A strong communicator with excellent verbal and written communication skills
A highly collaborative person who is able to respond to constantly changing circumstances and needs
Strong leadership skills, with demonstrated project or program management

Senior Clinical Trial Manager Resume Examples & Samples

Advanced degree or Bachelor of Science degree with equivalent job experiences
8+ years of Clinical Trial Management experience for medical device, pharmaceutical or biological products; experience in diagnostics preferred
A solid understanding of clinical project management and familiarity with project management tools
Understand and have experience related to the requirements of China controlling bodies and framework
Knowledge of pathology and/or oncology is necessary
Experience in working in parallel project teams
High work capacity is required at certain times in high priority projects
Experience in CRO/vendor management and contracting is preferred
Flair, enthusiasm and leadership capability when faced with project and professional challenges

Clinical Trial Manager Resume Examples & Samples

With 2+ years’ experience in project management skills as manager role, at least8 years’ experience in pharmaceutical/clinical research industry
Experience within the clinical trial management field, including the Bid Defense, project planning and execution management
The experience in leadership and/or management activities for a satisfactory progression is required
Key competencies such as critical thinking and problem solving skills, planning & organizing, risk assessment and mitigation skills
Project management experience which is out of China is preferred
Excellent communication ability and skills for interacting among internal & external customer, especially in English
Diploma or above education background, major in clinical or pharmacy area is preferred

Temp-clinical Trial Manager Resume Examples & Samples

Identification and Selection of Vendors
Initiation and Site Start Up
Understands current and future business trends and information

Global Clinical Trial Manager Resume Examples & Samples

Independently manages clinical trial project execution to ensure that trial timelines, costs, and quality metrics are met
Responsible for the preparation and finalization of project and study-related documents including: ICFs, protocols, study specific documents, regulatory documents etc., as required
Identifies and resolves clinical project issues and recommends corrective actions
Manages external vendors (CROs, clinical sites, Central Labs, IRBs)
Provides study-specific training to CRO, sites and other contract personnel
Monitors and tracks clinical trial progress, subject recruitment and provides status update reports
Plans, executes, and leads study-specific meetings
Develops monitoring plans and conduct monitoring visits as required
Reviews monitoring reports to ensure quality and resolution of site-related issues
Partner with other R&D groups to achieve deliverables
Works with Product Development to coordinate blinding, labeling, storage and shipment of study product and oversees clinical supplies logistics
Ensures compliance with all applicable laws, ICH/GCP/local regulations and regulatory guidelines
Leads the reviews of clinical data at the CRF, data listing, and report table levels, as well as clinical study report
Travel as required to carry out responsibilities
Other duties as may be assigned
BS/MS Degree in scientific discipline with at least 5 years of clinical research experience
Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management; Strong clinical study management skills
Excellent communication skills to effectively disseminate information to project team and outside parties
Experience developing trial plans including developing plan for site monitoring, site selection, and clinical supplies management
Excellent organizational, conflict resolution, prioritization and negotiation skills
Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
Ability to handle a high volume of highly complex tasks within a given timeline
Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
Willing to travel approximately 30% of the time

Clinical Trial Manager Resume Examples & Samples

Assist in the oversight of CROs and third party vendors, including co-monitoring, to ensure compliance with study protocol
Responsible for project start-up activities including but not limited to: site feasibility, site selection/recommendation, and regulatory preparation in conjunction with relevant departments
Monitor performance of investigational sites; prepare or review visit reports
Ensure studies are carried out according to the study protocol, applicable SOPs, and ICH/GCP regulations and study-specific manuals and procedures
Track and report on study progress and key study metrics
Reviews and approves the EDC system, study manuals, study plans and other study related materials
Perform clinical data review of data listings and summary tables. Generate queries as necessary
Oversee discrepancy management, ensure queries are appropriate and responses are timely
Manage study drug accountability, shipments, reconciliation and return process
Provides site, CRO and vendor training on new or amended protocols and other study materials as appropriate
Reviews invoices from sites, CROs and third party vendors to ensure work has been completed satisfactorily prior to payment
Provides support in the development of clinical protocols, SAPs, consent forms, and other program/study related documents
Manages relationships and establishes strong partnerships with CROs, vendors, investigators and other external partners
Works with the Head of Clinical Operations, legal, and finance (as well as other cross-functional team members as necessary) in the selection of CROs and other third party vendors
Member of cross-functional clinical trial teams (internal and external) representing Clinical Operations
Monitoring of clinical investigational sites (including PSSVs, SIVs, IMV, COV, co-monitoring and audit related activities)
Ability to write/edit clinical study documents in a coherent and complete manner
5-7+ years clinical experience in a pharmaceutical/biotech or CRO setting
5+ years as a site monitor
Experience managing all phases of clinical trials
Experience working in a fast paced environment with limited resources
Experience managing CROs and vendors
Ability to effectively work within cross-functional teams
Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
Experience with Electronic Data Capture systems
Ability to use MS Programs (e.g. Word, Excel, Outlook etc.)

Clinical Trial Manager Resume Examples & Samples

Line management experience required
Bachelor’s degree or licensed certified health care training
Significant clinical research experience (comparable to 3+ years) in all phases of study life cycle, including start up, interim and close out

Clinical Trial Manager Resume Examples & Samples

Eight or more years’ experience in clinical trial operations with at least 3 years’ experience in the management of complex oncology clinical trials. Previous global and/or hematology trial experience is desirable
Thorough knowledge of FDA regulatory requirements, ICH guidelines and GCP
Experience working with partner organizations both academic and pharma, biopharma, or CRO
Manage multidisciplinary study team(s)
Identify clinical trial investigators, perform pre-study visits for complex trials, manage site initiation visits, and develop trial-related training materials for study team members and clinical staff
Prepare detailed study timelines and clinical site budgets for assigned clinical studies
Develop and direct operational documents such as clinical monitoring plan, study management plan, study consent form, communication plan, medical oversight plan, study safety oversight plan, laboratory manual, and product administration guidelines
Work with Medical Writing and assigned Medical Director to develop clinical study protocols
Ensure the study eTMF is maintained, complies with company standards, and is periodically audited throughout the clinical trial
Identify and manage vendors as necessary to meet study goals and timelines. May develop RFPs and initiate contracts for CROs, central, bioanalytical or specialty laboratories, core radiology reading groups, etc
Produce monthly progress reports and risk mitigation plans to ensure assigned clinical trials are on target

Clinical Trial Manager Resume Examples & Samples

A Bachelor degree at a minimum
At least 4 years multinational clinical study management experience
Experience in clinical vendors oversight

Clinical Trial Manager Resume Examples & Samples

Act as Protocol Lead on one or more clinical trialsand serve as the main point of contact for clinical site management and clinical trial site monitoring functions
Participate as a member on assigned cross functional study team
Will assist with the design and review of clinical trial protocols, informed consent, CRFs, Statistical Analysis Plan, and Clinical Study Report in collaboration with medical monitor, biostatistician, regulatory affairs, senior management and other relevant groups. Participate in the Clinical Protocol Committee as appropriate
Create and maintain clinical trial start up documents such as the Clinical Monitoring Plan. Develop or provide clinical operations / clinical trial monitoring function input for other clinical trial start up activities, including; investigational drug supply plan, research specimen plan, CRF Completion Guidelines and other plans and processes as appropriate
Participate in the identification, evaluation and selection of clinical trial investigators/sites
Manage clinical trial site monitoring team metrics (i.e. monitoring frequency and trip report completion, CRFs expected/outstanding, Source Document Verification (SDV) progress, query aging, monitoring resource requirements, etc.) to ensure performance maximizes efficiency, quality, ICH/GCP adherence, and meet clinical trial and corporate goals
Provide support to field CRAs and may assist in the initiating, monitoring and coordinating day-to-day operations of clinical trial sites. May conduct monitoring visits including pre study, initiation, interim monitoring and close visits as needed
Coordinate and manage vendor processes for the clinical trial site monitoring function of clinical trials including central laboratories and Clinical Research Organizations (CRO)
Primary contact for CROs Clinical Trial Site Monitoring Team to ensure CRO’s performance to the terms of contract, CFR, ICH/GCP compliance, and overall quality of work
Oversee research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed
Facilitate information flow between clinical trial sites, clinical project team members and other members of the clinical operations team, external CRO or contracted members, clinical field team, vendors, and other personnel as appropriate
Ensure completeness ofClinical Trial Management System (CTMS) and Trial Master File (TMF) for assigned studies
May assist in the preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections

Clinical Trial Manager, Oncology Resume Examples & Samples

Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP
Serve as client advocate within Novella
Develop and implement Clinical Monitoring Plan
Assure that the appropriate Novella and/or sponsor SOPs are followed
Ensure all project documentation is appropriately filed per Novella SOPs
Assist PM in preparation of audit responses, as appropriate
Assist PM with preparation of information for inclusion in monthly report to client
Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions
Define the scope of work with the client and clinical monitoring team
Assist PM in identifying and generating changes in scope and notify client of potential changes in scope
Review and approve CRA travel expenses and time sheets
Thorough knowledge of clinical research process
Prior experience as a Clinical Research Associate
Excellent organizational and interpersonal skills
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
Ability to reason independently and recommend specific solutions in clinical settings
Working knowledge of current ICH GCP guidelines and applicable regulations
Able to mentor CRAs and more junior Clinical Trial Managers
Ability to travel domestically and internationally

Clinical Trial Manager Resume Examples & Samples

Manage the study star- up process including site list delivery, team process report completion, project map with clear timelines for the project and all supporting team members accountable to the project. Responsible to outline expectations to internal teams and sponsor/vendors to ensure successful study implementation
Protocol Review: review clinical trials for scientific merit as well as operational review for staff working in an outpatient community based setting. Review protocol procedures for standard of care vs. research related charges. Provide all supporting team members with the information and contacts they need in order to complete their tasks
Responsible for execution of clinical trials within the USOR network, from initial medical director & associate director approval until final study closure
Communicate with sponsor/CRO regularly throughout the duration of the study. Communicates clearly and routinely with the sites and associated network operations team regarding status of the project (at least monthly)
Oversee development and maintenance of USOR study tools (i.e. protocol specific flow sheets, clinical trial information sheets, and training documentation, etc.)
Implement research trials at the practice level and develop formats to ensure successful education of clinical research staff. Facilitates ongoing project training throughout the trial timeline. Serves as the study point of contact for all clinical research staff. All questions related to the protocol, billing, payout, monitoring issues, etc. are directed to the clinical trial manager
Review project status with the physician disease program leadership and participating sites. Provides the NPI as well as the client, monthly operational reports as well as clear direction on what the NPI needs to do to support the study
Work closely with network operations managers and regional directors to ensure sites meet study expectations, including but not limited to accrual, data entry and quality, and overall adherence to GCP and USOR SOPs
Review all monitoring and auditor follow-up letters as well as monitors survey forms for quality indicators. Works with the regional staff and quality assurance team to facilitate quality improvement programs (i.e. plans of actions) related to clinical trials
Responsible for submitting amendments timely and hold teams accountable to a timeline. Responsible for monitoring data completion and backlog
Demonstrated adaptability, handles day to day work challenges confidently, is willing and able to adjust to multiple demands, shifting priorities; shows resilience in the face of challenges, demonstrates flexibility Shows work commitment: sets high standards of performance; pursues aggressive goals and works efficiently to achieve them

Clinical Trial Manager Resume Examples & Samples

A minimum of a Bachelor’s Degree (Life Sciences strongly preferred- Animal Science, Biology, Physiology, Nursing, Medical Technology) plus 5 years of experience in medical device/drug clinical research
Strong knowledge and experience in project management
Ability to manage complex projects successfully
Strong Excel and database (specifically Access and Siebel required)
Knowledge of and experience in experimental design
Knowledge of computerized databases for the maintenance of scientific data
Basic understanding of statistics and statistical methods
Prior participation in all facets of clinical studies required
Strong technical or clinical background required
Project Management Certification preferred
Experience with Good Clinical Practice (GCP)
Experience with Good Laboratory Practice (GLP) and Good Manufacturing Procedures (GMP) is preferred
Effective strategic, analytical and problem solving skills
Ability to strategically and effectively communicate with cross-functional colleagues, internal leadership, and external professionals to appropriately convey essential information and ensure favorable project outcomes
Effective written and verbal communication skills in the area of technical/clinical applications. Strong command of medical and surgical terminology
Demonstrated ability to identify problems, perform basic root cause analyses, and propose effective solutions
Ability to appropriately apply different standards related to medical devices/ clinical research (SOPs, GCP, ISO, ICH, FDA, MedDev, etc.)
Effective knowledge in searching medical literature and scientific databases for clinical and technical information
Ability to work with a minimum of supervision
Effectively anticipates and adjusts to changes and uncertainties, able to project future trends and issues
Demonstrated aptitude for achieving goals through understanding of process, ability to prioritize, and internal
Demonstrates ethics and Integrity
Problem solving: analyzes complex issues and significantly improves, changes, or adapts existing methods
Demonstrated ability to manage projects
Ability to identify critical information needs and identify roles/individuals to involve for decision making within clinical studies
Occasional: Activity exists less than 1/3 of the time
Frequent: Activity exists between 1/3 and 2/3 of the time

Clinical Trial Manager Resume Examples & Samples

A minimum of a Bachelor’s Degree with at least 8 years of clinical or related technical experience required
A minimum of 2 years’ experience leading teams; supervisory experience is required
Advanced project management skills with ability to handle multiple projects required
Experience with line management is preferred
Medical device experience is preferred.Clinical Trial Administration

Senior CRA / Clinical Trial Manager Resume Examples & Samples

Manage Study Team to achieve corporate and Project Team milestones on time and on budget
Provide oversight of study team conducts to ensure overall study monitoring compliance
Updates study plans with forecasts, including but not limited to site start up, enrollment, and closure
Reviews and approves site visit reports
Provides oversight of TMF submission and maintenance
Reviews and approves invoices from investigators and service providers
Develops and fosters positive working relationships with colleagues, development and service partners
Eight-years of clinical research related experience
Five-years of experience leading teams
Strong working knowledge of GCP/ICH regulations
Demonstrated superior communication and collaboration skills
Demonstrated leadership skills in multi-disciplinary situations
Ability to effectively interact with all levels of management
Ability to resolve problems positively and professionally
Have an in-depth understanding of clinical research. Have a working knowledge of the relevant SOPs
Ability to exercise judgment within generally defined practices and policies for obtaining data
Self-direction and motivation

Clinical Trial Manager Resume Examples & Samples

Management of global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the clinical development plan, GCPs, ICH and FDA requirements
Recruit global study sites and foster relationships with study investigators
Manage study vendors (e.g., CRO, IRT/IXRS, laboratories)
Monitor the progress of trials including enrollment and clinical trial material inventory
Provide progress updates to management
Develop protocols, consent forms, IRB/EC materials, and other trial documents
Develop procedural plans
Negotiate of site contracts and budgets
Verify monthly accruals from vendors and study sites
Assist in case report form (CRF) development and programming of electronic data capture
Assist in reviewing project review specifications for IRT/IXRS
Participate in Data cleaning and database locking
Participate in the process of site and vendor selection and qualification
Prepare or review and approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, monitoring plans, and monitoring reports
Chair clinical trial meetings-updating clinical staff and upper management on patient recruitment, trial issues, investigator’s feedback, monitoring issues, patient enrollment issues and presenting a plan of action for resolution of issues
B.S. in Biological Sciences or related scientific discipline
Minimum of five (5) years’ experience with design and execution of related oncology trials
Must be able to thrive in an entrepreneurial, fast-paced and dynamic work environment
Must be organized and be able to communicate effectively
Undergraduate degree in life sciences or professions (pharmacy, medicine, nursing, or other allied health sciences)
At least 5-10 years of relevant oncology experience in clinical operations in pharmaceutical company or CRO including trial set-up, monitoring, and close-out of US and non-US trials at all phases of pre-NDA clinical research (Phases 1-3)
Demonstrated excellence in trial management skills, with track record of successfully managing multiple projects, trials, and priorities
Experience with managing study vendors (e.g., CRO, IRT/IXRS, laboratories)

Clinical Trial Manager Resume Examples & Samples

Evaluate, monitor and facilitate the flow of clinical data to ensure accuracy
Manage investigational sites to ensure compliance with protocol and overall clinical objectives; including traveling to sites to conduct pre-study, initiation, interim and closeout visits and/or co-monitor with CRO or contract associates
Negotiate contracts and budgets with clinical investigational sites and other vendors
Participate in data review, analysis and report writing
Interface with other departments within the organization to exchange technical data and negotiate courses of action on behalf of CRMA
Previous management or project management experience with demonstrated leadership ability
Ability to determine the people, funding, materials and support to meet project goals and timelines
Knowledge of FDA and international regulatory requirements
Able to work in ambiguous, fast-paced environment
Excellent time management skills (timelines, schedules, task prioritization)

Clinical Trial Manager Resume Examples & Samples

Ideally 5+ years pharmaceutical industry experience with 3-5 years’ strong experience in clinical research
Experience in a monitor role or a role overseeing clinical trials
Strong Project Management and leadership skills

Clinical Trial Manager, Oncology Resume Examples & Samples

Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including
Coordinate site management activities
Site identification, recruitment, and selection
Regulatory document collection and review
Overall scheduling and management of all site visits
Develop site/monitoring tools and training materials
Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions

Senior Clinical Trial Manager Resume Examples & Samples

Support all project management activities for Data Generation project as assigned within the Medical Research Operation group
Support in contract finalization and execution, e.g. filling in contract templates
Regular updates in internal clinical trial management system for departmental projects and compiling reports from the system
Support the Head of Regional Medical Research Operation with SOP and Quality management
Act as a key point of contact between Medical Research Operation group and the registries
Act as a Liaison with Global medical research and Quality in matters related to GCP, SOPs and training

Clinical Trial Manager Resume Examples & Samples

Minimum of 7+ years of clinical research experience with minimum of 5+ years of CRO/sponsor monitoring
Flexibility in travel to sites as needed. Expected to be on average 25% of time based on project needs
Strong customer service and relationship building skills with sites (on site and remote)
Strong Site Management and Project Management skills including risk assessment and contingency planning
Demonstrate a high degree of learning agility
Possess a combination of critical thinking and operational know-how and efficiency
Demonstrated success in working independently
Strong preference for experience with late phase and observational clinical research
CNS and MS experience preferred

Clinical Trial Manager Resume Examples & Samples

Management of the Clinical Trial Office
Superpervision of Research personnel and staff, performance evaluations, employee development, education, compensation and payroll
Interface with all study sponsors, CROs, Medical Science Liaisons (MSLs)
Final study budget approval
Collaborating with principal investigators, co-investigators to enroll clinical trial patients
Collecting, processing and storing samples for research
Assessment of adverse drug reactions and other serious adverse events
Patient education and follow-up
Abstracting data from patient charts and electronic medical records
Minimum requirement for this position is a BSN. A Registered Nurse and two years of related experience may be substituted for the Bachelor’s degree
Previous supervisory experience
Experience working in research and/or clinical trials
Five years of work experience in a clinic, hospital, or clinical research setting

Global Clinical Trial Manager Resume Examples & Samples

Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study design to close out at a global level in accordance with ICH-GCP
Oversee the quality and scientific integrity of clinical operations for studies at a global level
Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
Leading the Clinical Study Team to drive effective decision making
Planning, management and reporting of clinical studies conducted by Global Development through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables
Ensuring implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
Management of vendors to the required standards
Travel as required to support the execution of clinical studies as required
Regional clinical project management experience
Global clinical project management experience
Extensive clinical research experience working in life sciences or medically related field, including general biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company)
Advanced knowledge of global clinical project management
Knowledge of time, cost and quality metrics, Key performance indicators (KPIs)

Clinical Trial Manager Resume Examples & Samples

Supports the Sr. CTM/operational study lead in collaborating with clinical affairs and other functions, and responsible for, the execution and delivery of studies
Responsible for the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as SOPs and policies
Responsible for monitoring assigned aspects of the study operational plan
Responsible for managing assigned aspects of the operational study budget, timelines, and risk mitigation processes with input from key stakeholders
Supports the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness
Supports the Sr. CTM in managing the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with the study team and key stakeholders

Clinical Trial Manager Resume Examples & Samples

Lead and manage large projects (i.e. Phase III project(s) with 500-1000 subjects and a possible NDA submission)
Act as team leader to coordinate and lead the project team that includes internal and external team members (e.g. Clinical Operations, Clinical Research Organization (CRO), and all other Outsourcing Partners)
Delegate day to day activities to appropriate team members across all relevant departments
Demonstrate innovation by contributing to group growth and being proactive in the areas of problem solving and efficient use of resources
Demonstrate flexibility to change and grow with organizational and project needs
Ability to manage financials associated with a Phase 3 program
Continually evaluate and suggest improvements in project procedures; ability to see the overall project as well as the ability to focus on particular aspects
Act as a mentor to other project personnel
Minimum 8-10 years experience in Clinical Operations in Pharma required
8+ years experience in the clinical trial management role leading large Phase 3 trials required
3+ years CRO and vendor management experience required

Senior Clinical Trial Manager Resume Examples & Samples

Manages clinical studies, including vendor management and oversight including CROs, IRB, DSMB
Organize and participate in investigational meetings and site training
Coach and mentor all staff under him/her; set objectives, solicit 360° feedback from stakeholders and conduct performance reviews to foster growth of staff
Ensure all necessary training is provided to his/her staff to support job performance and knowledge; remain cognizant of, and remove, any barriers or obstacles that impede his/her staff from achieving objectives
Participate in study start-up activities including protocol authoring, database design, study manuals, essential documents etc to ensure the operational team is poised for successful data to enable the program strategy
Oversee site selection, patient recruitment and retention
Author documents necessary for study initiation and execution; ensure other documents and manuals are provided for study initiation and execution
Interact effectively with Sr. Management within clinical operations and cross functional areas to provide updates and communicate issues
Manage drug supply needs by communicating with the relevant IVRS vendor, study sites and the Amicus Technical Operations team
Work closely with Translational Sciences to ensure timely and appropriate shipping of samples
Communicate regularly with Data Management to ensure data are being cleaned and coded appropriately and in a timely fashion
Interface with other team members, including Clinical Research Associates, to be aware of issues at sites that require attention
Minimum of 5-8 years of experience managing clinical studies in a pharmaceutical or biotechnology setting. At least 1 year of clinical monitoring experience or equivalent is desirable
Managing orphan drug disease trials is desired
Thorough knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, SOPs
Solid scientific background; able to understand biomarkers and clinical endpoints
Excellent command of MS Powerpoint, Word, Excel and Project
Self-motivated and able to function with little supervision
Highly detail-oriented
Able to multi-task
Superior communication skills, both verbal and written; able to synthesize complex data and ideas and summarize for senior management
Able to resolve conflicts in a diplomatic manner
Ability to manage up and down
Good negotiation skills
Solid problem-solving and decision-making skills

Senior.clinical Trial Manager Resume Examples & Samples

Global Phase I subject and patient trials, safety reporting, and regulatory WMA submission experience
Ability to effectively multi-task and prioritize
Solid computer skills requirement of MS applications including (but not limited to) MS Project, Word, Excel
Study Tools including electronic system skills CTMS / EDC

Functional Manager, Clinical Trial Manager Resume Examples & Samples

BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy),
Requires clinical research operational knowledge, project planning/management and communication skills. Should be flexible and have experience and ability in managing global or regional teams in a virtual environment
Demonstrated experience managing and mentoring clinical operations team members. Effective leadership skills and proven ability to foster team productivity and cohesiveness is required
Experience with CRO and vendor management and oversight is preferred

Clinical Trial Manager Resume Examples & Samples

Manages clinical trials from start-up to close-out, ensuring study conduct is in compliance with appropriate SOPs, ICH-GCP guidelines and regulatory requirements
Collaborates with internal team members and external trial to ensure study deliverables are on-track to achieve agreed-upon protocol timelines
Identifies and selects Principal Investigators by reviewing and assessing completed feasibilities to deliver Canadian randomization targets by agreed upon timeline
Prepares clinical trial documents by creating, revising, and translating documents and adhering to local guidelines ensuring approval from Health Canada and ethics committees
Develops clinical trial budgets, negotiates contract payment terms and analyzes remaining budget on a quarterly basis ensuring achievement of overall study budget
Reviews monitoring reports, adhering to local guideline and providing feedback to Monitors ensuring adequate and accurate documentation of activities and issues identified during monitoring visits to adhere to Novo Nordisk SOPs
Completes system training in order to adhere to reporting timelines to meet required deliverables
Manages the Sponsor and Health Authority Regulatory audit process in Canada by providing support to other team members during audit preparation, addressing questions from Auditor and clarifying audit responses
Represents Novo Nordisk Canada at Investigator meetings and International Study Group meetings presenting Canadian viewpoints, treatment guidelines, recruitment challenges and regulations
Establishes communication with Denmark, US, external trial staff and Regional Monitors by providing prompt responses to questions specific to the protocol, contract and payment terms and policies and procedures
Acts as back-up to Clinical Trial Managers and BioPharm Clinical Trial Manager during absences, as requested

International Clinical Trial Manager Resume Examples & Samples

Provide direction and leadership to one or more Study Management Teams
Build effective and efficient high performing SMTs and ensures team members are aware of their accountabilities, responsibilities and deliverables
Be responsible and/or contribute to the development and management of the study timelines, resources, budget, risk and quality plans
Provide clinical operations expertise to ensure operational feasibility and delivery of the clinical studies
Develop and execute operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
Provide the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work acts in line with legal, regulatory and company standards and codes of practice (eg Roche Code of Conduct, applicable Roche directives, guidelines and SOPs)
Effectively forecast and maintain the study budget, with timely and miticulous attention to meet finance forecast and review tiemlines

Senior Clinical Trial Manager Resume Examples & Samples

As the operational study lead, serves as the primary representative of Clinical Operations to Clinical Affairs and other functions supporting the execution and delivery of an assigned study(s) (e.g. Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance)
Supports the Clinical Program Manager by providing study status updates, and informs and as needed escalates issues; Provides operational support as needed at various meeting interactions
Accountable for the execution and adherence to integrated study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders inclusive of all operational accountabilities, including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as FRI’s SOPs and policies
Accountable for monitoring study operational plan, and managing operational study budget, timelines, and risk mitigation processes with input from key stakeholders
Accountable for direct supervision and mentoring of Clinical Trial Managers
In collaboration with key stakeholders, responsible for supporting the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across

Clinical Trial Manager, ICO Resume Examples & Samples

Primary point of contact for Clinical Operations aspects of designated projects and responsible for developing successful working relationships with clients
Responsible for planning, scheduling and implementing the Clinical Operations aspects of projects
Responsible for risk mitigation strategies, associated action plan and issue resolution
Responsible for managing the Clinical Operations project team, including ensuring all necessary project training is provided to assigned staff
Provide direction and support to the Clinical Operations study team
A satisfactory progression of monitoring experience, along with previous experience in leadership and/or management activities
Experience in Late Phase monitoring a plus

Clinical Trial Manager Resume Examples & Samples

Determines site qualification criteria and manages the identification of potential investigators and clinical sites; oversees, performs or participates (as needed) in pre-study site visits, reviews evaluative reports; performs or participates in the final selection of study sites
Reviews the site approval process with respect to critical document requirements, Institutional Review Board (IRB) approvals, IRB questions, site informed consent review, and review of contracts, in conjunction with relevant internal departments (as necessary)
Approves shipment of investigational product to sites
Tracks and assesses study budgets as they relate to actual study progress, timelines, and/or work being performed by external vendors (CROs, CRAs, centralized laboratories, etc)
Oversees and participates in Investigator Meetings
Oversees the day-to-day activities of the clinical trial and associated resources (CROs, CRAs, centralized laboratories, etc)
Identifies and evaluates issues related to the project and coordinates resolutions
Initiates and responds to CAPAs as required
Coordinates vendor activities as needed
Ensures adequate Serious Adverse Event reporting including documentation, tracking and follow-up
Assists in the site audit process
Manages site close-out process and ensures final site issues are addressed appropriately
Reviews Tables, Listings and Figures
Coordinates CSR writing, review and approval process including the compilation of all required sections
Responsible for quality of Trial Master File and other Sponsor deliverables
Excellent communication, writing and presentation skills; proficiency in English
Ability to organize team meetings
Ability to foster effective relationships with vendors, investigators and colleagues
Proficiency in study monitoring activities
Demonstrated effective time management skills
Working knowledge of ICH guidelines, Good Clinical Practices, HIPAA and applicable regulations, and guidelines related to the clinical trials

Clinical Trial Manager, Oncology Resume Examples & Samples

Prior CRA experience and a minimum of 2 years as a Clinical Trial Manager / Clinical Study Manager in the UK or Europe
Previous strong Oncology experience
Strong communication skills, both written and verbal with fluency in English and the local language
Excellent interpersonal and organisational skills

Senior Clinical Trial Manager Resume Examples & Samples

Experience in the following areas is highly desirable: Graft-Versus-Host-Disease, Gastro-Intestinal, Cardiovascular, Interventional Radiology, Multipotent Stem Cells
Strong abilities to multi-task and work with limited supervision
Ability to maintain professional and positive attitude
7+ years of Trial Management experience
Bachelor’s degree in science or related area

Senior Clinical Trial Manager Resume Examples & Samples

Should be flexible and have experience and ability in managing global or regional teams in a virtual environment
Experience with supervision of CROs/vendors is preferred
Experience in GCP and ICH Guidelines is preferred
Willing to travel up to 20% of time, domestically and internationally7275170407

Clinical Trial Manager Resume Examples & Samples

Writes study protocols, protocol amendments, informed consents, clinical study project timelines and scientific papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying abreast of current clinical practice. Efforts and leadership supports product approval, indication expansion and claim support, and mandated post market requirements
Leads the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction. Provides project leadership and scientific expertise throughout the development and implementation of local or global clinical studies. May lead studies executed by a CRO
Provides clinical input for new product development, post market surveillance, recertification and business development.Interacts with various study support groups in order to assist in clinical strategy, the development of study plans, and project deliverables
Interacts with regulatory agencies as needed, and will use their scientific knowledge in order to provide directives to staff as well as study sites
Strong preference for a professional with a wide-range of experience and expertise in a specialized technical field
Ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/relationships
CRM Clinical trial or technical experience desired

Senior Clinical Trial Manager Resume Examples & Samples

Leads and drives the project team in the planning, execution and management of all operational aspects of large-scale, complex, and/or business critical clinical trials
Informs and presents study progress and known risks to Senior Leadership
Provides clinical input to product development activities; represents Clinical on product development teams
Bachelor’s degree and 10+ years of related work experience or an equivalent combination of education and work experience
Clinical trial experience required
Project management experience required, managing scope, budget and timeline
Financial acumen required; Clinical budget management experience required
Ability to independently implement action plans and align activities with project, program and business objectives without significant supervision

Clinical Trial Manager Resume Examples & Samples

Leads, directs and executes clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures
Tracks development of and collaborates with the project team on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions
In collaboration with the project team, leads the proactive identification, assessment, and management of clinical study risks
Bachelor’s degree and 7+ years of related work experience or an equivalent combination of education and work experience
Project management / leadership experience preferred
Financial acumen required; Clinical budget management experience preferred
Ability to work collaboratively and influence a broad range of global stakeholders

Clinical Trial Manager Resume Examples & Samples

Leadership in a professional and ethical manner
Advanced technical writing skills
Masters or equivalent required; preferably in Life Science, Nursing or Biological Science
8 -10 years of relevant experience or equivalent required
Clinical/medical background a plus

Clinical Trial Manager Resume Examples & Samples

Manages the operational aspects of clinical trials
Manages the study project plan, including timeline, budget and resources
Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
Participates in protocol, CRF and strategy development, Clinical Study Report preparation, NDA submission, as appropriate
Prepares metrics and updates for management, as assigned
Participates in and facilitates CRO/vendor selection process for outsourced activities
Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
Recommends and implements innovative process ideas to impact clinical trials management
Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
May manage clinical operations staff
A Bachelor of Science degree required
A minimum of 8 years of related clinical trial management experience
Rare Disease and/or Oncology experience preferred
Experience in managing outside vendors, e.g., CROs and other vendors
Strong knowledge with advanced concepts of clinical research and able to work effectively in a team/matrix environment
Strong knowledge and experience of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
Ability to provide clinical expertise to a clinical development in a specified product area or project
Excellent written and verbal skills required. Must display strong analytical and problem solving skills. Attention to detail required
Must be willing to travel up to 25% time

Clinical Trial Manager Resume Examples & Samples

Lead cross-functional team with regards to study activities and risk mitigation
Manage CROs and multiple other external vendors to support clinical studies, develops and revises scope of service agreements, budgets, plans, and detailed timelines as necessary
Independently oversee study activities, including: engagement of investigators, study start-up activities including site initiation, study monitoring activities, data collection and close-out activities
Provide oversight of the CRO to ensure compliance with Merrimack’s quality measures
Develop and manage comprehensive study timelines and metrics and ensures completion of study deliverables
Oversight of trial budget and vendor contracts
Contribute to the development of study related documents (contracts, ICFs, protocols, IBs, etc.)
Participate in development of CRFs, including User Acceptance Testing
Manage and communicate study enrollment projections
Address and escalate relevant operational issues to key stakeholders
Be aware of and be able to predict deviations, or potential non-compliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate appropriately
Provide portfolio support across the organization

Clinical Trial Manager Resume Examples & Samples

Writes study protocols, protocol amendments, informed consents, clinical study project timelines and scientific papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying abreast of current clinical practice. Efforts and leadership may support product approval, indication expansion and claim support, and mandated post market requirements
Leads the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction. Provides project leadership and scientific expertise throughout the development and implementation of local or global clinical studies
Informs and presents study progress and known risks to Clinical leadership
May facilitate regulatory submissions and communications by communicating with Regulatory Affairs during the submission process
Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Medical Ethics Committees, etc. May include clinical risk management activities including input into Hazard Analyses, product FMEA and DFUs and authorship of Clinical Evaluation documents (CDSR) for identification of harms and support of safety performance for product approval
Mentors and coaches all level of Project Management

Clinical Trial Manager Resume Examples & Samples

Receive an attractive on-sign bonus (experience dependent. For limited time –apply now!)
Join a stable company, with continued growth and where people tend to stay for 6-10 years rather than 1-3!
Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance
ONCOLOGY focused
On-going communication with investigators to establish successful relationships and ensure engagement through protocol and scientific discussion
Pro-actively drives/tracks execution and performance of deliverables/timelines to secure country commitments for assigned protocols
As accountable for quality and compliance, will oversee study progress of a team of CRAs and CTCs, including such duties as: training compliance, quality control visits, monitoring visit report review, proactively identifying, managing and escalating site issues
Ensure resolution of site issues in order to maintain strong investigator relationships
Support Audit/inspection for assigned protocols when needed, and follow through audit/inspection finding resolution
Support smooth/timely resolution of challenges with study start up or contract activities when needed

Clinical Trial Manager Resume Examples & Samples

Recent oncology experience in the last 3-5 years required
5+ years’ experience in clinical study or program management, including study start-up, conduct, and close-out of trials (level determined by experience)
Solid technical knowledge of oncology therapeutic area required
Experience in oversight and management of Clinical Research Organizations (CROs), central laboratories, and other vendors required
International trial management experience desired
Phase I study management experience desired

Clinical Trial Manager Resume Examples & Samples

FPA144 – a monoclonal antibody targeting FGFR2b in a Phase 1 clinical trial in FGFR2b over-expressing gastric cancer
Support defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines
Serve as a member of one or more cross-functional Study Execution Team(s) (SET)
Contribute to the development of RFPs for assigned vendors, review proposals and make award recommendations, participate in selection of CROs and vendors
Day-to-day management of assigned vendors to ensure that project goals are achieved; organize and lead teleconferences with key vendor personnel, facilitate vendor activities and oversee adherence to scope of work and service agreement
Manage study budget for assigned vendors; review invoices for assigned vendors, identify and communicate variances for assigned vendors
Partner closely with Senior CTM/CPM, Clinical Development and CRO to identify and select clinical trial sites
Perform oversight and/or co-monitoring visits of clinical sites as required by the needs of project
Review and approve monitoring reports and escalate issues and risks to Senior CTM/CPM
Assist with ensuring that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled
Coordinate and participate in routine and final database lock data listings review
Participate in implementation and oversight of study systems e.g, CTMS, TMF, EDC,or IxRS
Contribute to creation and implementation of assigned study management plans, (e.g. monitoring, vendor oversight, TMF oversight)
Ensure that supportive study supplies and documents are available (e.g., contracts, IXRS, lab kits, non-clinical supply materials)
Reconcile site payments against patient visits to ensure accurate payments
Track key study activities using tracking tools
Identify issues and risks, and propose potential resolutions
Assist with planning investigator meetings and developing content and/or site training materials
Assist with training vendors and team members on study protocol and processes
Attend meetings, takes and distributes meeting minutes

Clinical Trial Manager Resume Examples & Samples

Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects
Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings
Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department
Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits and be accountable for project financials
May communicate with sites regarding issues such as protocol, patient participation, CRF completion and other study-related issues
May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions are addressed. Ensures that essential document quality meets the expectation of Regulatory Compliance Review. Reviews and follows up on all questions raised by the ethics committees
May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
Good planning and organizational skills to enable effective prioritization of workload
Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
Good judgment and decision making skills
Effective oral and written communication skills, including English language proficiency
Capable of evaluating workload against project budget and adjusting resources accordingly
Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc
Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc
Able to travel 10-20%
No management responsibility

Clinical Trial Manager, Oncology Resume Examples & Samples

BS/BA (or equivalent) in one of the life sciences with a minimum of 4 years direct experience in clinical studies or equivalent level of education and experience
Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis
Minimum of 2 years as a successful Lead CRA or Clinical Trial Manager
Ability to work independently, prioritize and work with a matrix team environment is essential
Working knowledge of Word and Excel
Prior experience in electronic data capture (EDC) preferred
· Ability to travel domestically and internationally

Senior Clinical Trial Manager Resume Examples & Samples

Manage external vendors and contract research organizations
Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents
Assist with protocol development and study report completion
Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
Provide guidance, direction, and management to CRAs
Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
Coordinate study supplies
Negotiate contracts with vendors of clinical trial services
Review Informed Consent Forms, CRFs, and study related materials
Plan and participate in investigator meetings
Assist and support data query process
Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines
Ensures trial master file is current and maintained
At least 5 years of experience in clinical trial management
Experience in Oncology is preferred
Proven Management of people in a matrixed environment
Management of global clinical trials
Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
Travel required. Must be willing to travel 15-25%, including international travel
Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
Excellent oral and written communication skills and strong organizational abilities
BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred

Clinical Trial Manager Resume Examples & Samples

Manage clinical trial projects to ensure organized and uniform execution across the various locations at the site level in accordance with USON SOP and ICH GCP guidelines
Work collaboratively with individuals cross-functionally across the organization. Acting as the point of contact for education and support related to trial specifics and implementation plans
Anticipate and identify potential issues and create contingency plans with strategic input to projects to ensure accrual and quality goals are met
Recommend, lead, and implement tactical process improvements. Responsible for contributing to a culture of process improvement, performance measures, and developing successful solutions
May act as a primary contact for sponsors/CRO and vendors on certain projects to facilitate the above goals

Associate Clinical Trial Manager Resume Examples & Samples

Communication - Maintains timely and effective communication among team members and site staff. Routinely anticipates/identifies potential issues and implements corrective actions independently. Keeps project leadership apprised of team issues, seeking guidance as needed. Demonstrates effective conflict resolution
Regulatory Documentation - Assures compliance with local regulations, Code of Federal Regulations (CFR)/ International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Participates in TMF and on-site audits as requested. Responds to findings without oversight. May be responsible for submission of regulatory packages to ethics committees and/or competent authorities
Monitoring - Responsible for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; regularly reviews the status of the contents of the site regulatory binder; exhibits superior time management skills; may perform training visits with less experienced CRAs; and may perform assessment of less experienced CRAs during the sign-off visits
Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Highly proficient with multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed
Administrative - Prepares for and attends Investigator meetings. May attend Customer and Business Development meetings. May present materials, as requested. Assists with the preparation of study start-up materials and tools, as requested. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring and/or training plans

Clinical Trial Manager Resume Examples & Samples

Advanced cross functional awareness
BA / BS
Minimum 4 years’ clinical study management experience including multinational experience
Leadership / influence management skills
In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
Time management skills – ability to effectively multi-task and prioritize
Disease / therapeutic knowledge
Study Tools including electronic system skills – CTMS / EDC

Clinical Trial Manager Resume Examples & Samples

Ensure regional/global clinical operations deliverables progress according to agree upon timelines and milestones as leader of the Study Management Team (SMT). Support GTL in managing related CRO activities. This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned by the GTL
Minimum of 6 years clinical trial management experience in the pharmaceutical industry or CRO; preferably experience in global project management
Immunology experience preferred
Requires clinical research operational knowledge, strong project planning/management and excellent communication skills
Proven track record in successfully managing trials from start-up to database lock
Strong decision-making and communication/collaboration skills are essential to this role, as are analytical skills and effectiveness in seeking solutions to issues

Clinical Trial Manager Resume Examples & Samples

Shall provide assistance in and administrative efforts in order to efficiently and effectively monitor the clinical trial process
Verify and ensure that the rights and well-being of the human subjects enrolled in the clinical trials are protected and that the reported trial data are accurate, complete, and verifiable from source documents
Ensure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with ICH current GCP, FDA CFR, USAMRMC, OTSG-DA, and DoD, along with other applicable Sponsor and regulatory requirements, requirements of host countries and other government regulations
Shall lead the development, coordination, and implementation of monitoring and administrative strategies essential to the successful management of clinical trials research
Conduct site pre-qualification and initiation visits; verifying that assigned research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout trials
Conduct on-site clinical monitoring that includes; protocol training prior to study start, document reviewing, ensuring accurate data recording, monitoring adverse events, concomitant medications, and inter-current illnesses and verifies they are reported in accordance with the protocol on the Case Report Form (CRF), verify patient data, ensuring adherence to the clinical protocol, site and Sponsor SOPs, investigational product accountability, verification of product shipping/storage conditions, etc
Conduct closeout site visits, including reviewing record retention requirements, investigational product reconciliation and securing and reviewing investigator’s final report
Work effectively as part of an Integrated Product Team (IPT) and act as the Sponsor’s liaison to resolve site related issues quickly and effectively
Prepare trip reports and recommend corrective and preventative actions, where appropriate, in accordance with USAMMDA SOPs
Maintain written or email communication as well as telephone communication with the clinical sites. Telephone communications will be documented in minutes
Advance training in GCPs as well as significant experience in clinical trial monitoring, including paper and Electronic Data Capture (EDC) studies
Bachelor's degree in Science/Health related field (i.e. Nursing, Medical Terminology, Biology or Biochemistry) or equivalent education, or experience
Must be a US Citizen
5+ years of experience

Clinical Trial Manager Resume Examples & Samples

Lead defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines
Serve as a member of one or more Clinical Operations study management teams (SMT) and as a member of the cross functional study execution team (SET). May lead a SET as required by the needs of the project
Participate in CRO and vendor selection; develops RFPs for study vendors, review proposals and make CRO and vendor selection recommendations in collaboration with the SET
Study budget management; review invoices for assigned vendors, identify and communicate accruals and variances, provide input to study budget forecast
Conduct site feasibility and partner with SET and CRO to identify and select clinical trial sites
Partner with Contracts department on the development of site budget and clinical trial agreement (CTA) templates and on the negotiations with clinical sites. Ensure site payments are accurate and reconciled against patient visits
Perform oversight and/or co-monitoring visits of clinical sites, as required
Review CRO monitoring reports and ensure completion of action items. Identify trends and risks. Escalate unresolved issues
Partner with SET, vendors, and sites to ensure that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled
Participate in routine and final data listings review
Participate in implementation and oversight of study systems (e.g., CTMS, eTMF, or IxRS)
Create and implement assigned study management plans, (e.g. monitoring, vendor oversight, TMF oversight)
Ensure that supportive study supplies and documents are available (e.g., contracts, IxRS, lab kits, non-clinical supply materials)
Track key study metrics, track study activities and create study-specific tracking tools
Plan investigator meetings and develop content and/or site training materials
Proactively identify issues and risks and propose mitigation
Attend SET meetings, develop agendas, take and distribute meeting minutes
Participate in department process improvement initiatives and system implementation, review and provide input on working practices, SOPs and departmental infrastructure

Clinical Trial Manager Resume Examples & Samples

Experience managing drug trials in a pharma/CRO environment preferred
Experience as a field CRA preferred
Sound financial acumen and knowledge of budgeting, forecasting and fiscal management

Senior Clinical Trial Manager Resume Examples & Samples

Ensure /global clinical operations deliverables progress according to agreed upon timelines and goals as leader of the Study Management Team (SMT). Support GTL in running related CRO activities. This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned by the GTL
Establish enrolment dedications and ensure actual enrolment meets projected dedications across the regions at the clinical trial level
Build and update study-specific documents such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, country and site feasibility related documents. Provide input into cross functional documents such as Safety related documents, Protocol Deviations and Critical issue processes, External Service Provider Oversight Plan, Filing and Archiving Plan
Build appropriate trial-specific training materials and requirements, making them available to the GCO site study staff and delivering training as needed. Responsibilities include set-up and coordination of Investigator Meetings, if applicable, in close collaboration with GCO staff as well as GTL
Act as the primary contact person for the local teams within GCO. Establish and maintain excellent working relationships with internal partners, including Local Trial Managers. Demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledge
Provides updates to all SMT as well as Trial Team members on the deliverable status. Ensure required reports are generated and available for real time tracking of trial status. Manage timely and accurate documentation, communication of study progress and critical issues
Minimum of 8 years’ clinical trial management experience in the pharmaceutical industry or CRO is required
2 years of global project management
Cardiovascular and metabolic diseases experience strongly preferred
Should be flexible and have experience and ability in running global or regional teams in a virtual environment
Consistent track record in successfully running trials from start-up to database lock
Effective leadership and delegation skills and validated ability to foster team productivity and cohesiveness. Computer literacy is also required

Clinical Trial Manager, CDx Resume Examples & Samples

Bachelor´s degree in biological or biochemical sciences required, or equivalent job experience
Advanced degree and/or clinical certification preferred
A minimum of 10 years of Clinical Trials experience for diagnostics, medical device and/or pharmaceutical/biological products (8 years of Clinical Trials experience if 2 years of IVD experience included)
Understand requirements of various controlling bodies and framework
Experience in working in parallel projects teams
Flair, enthusiasm and leadership when faced with challenges

Clinical Trial Manager Resume Examples & Samples

Serves as primary study team contact to manage the start-up, conduct and close-out of clinical studies
Leads the cross-functional study execution team to ensure that project milestones are met and adhere to approved budgets and are in compliance with ICH/GCP and local Regulatory Authorities’ guidelines
Helps with the development, planning and forecasting of budget requirements for the clinical programs and clinical study sites
Manages CRO and vendor evaluation, selection, training and oversight
Facilitates site feasibility/selection processes
Conducts Sponsor quality monitoring/oversight visits to sites as needed
Provides strategic and operational input into the development of study documents including the study protocol, ICF, CRFs, pharmacy manual, laboratory manual etc
Oversight of preparation and submission of safety reports (pharmacovigilance)
Supply chain management. Forecast and manage investigational drug labeling, packaging and distribution
Ensuring clinical record keeping in preparation for audits and inspections
Identification and engage of thought leaders, investigators, cooperative groups and other experts regarding latest clinical thinking, study design, study conduct and interpretation of study results
In conjunction with data management, assist with eDC development, preparation and/or review of data listings, issue and query resolution
Collaborate on the development and set-up of study systems (e.g. IVRS/IWRS, site payments and CTMS)
Develops and reports key executional metrics for the oversight of the clinical trials
Assists with creating, reviewing and implementing SOPs and processes in clinical development
Approximately 10-15% travel may be required
Bachelor’s degree preferred. Certification in health-related field or Associates degree required. Preference in a health care or scientific discipline
At least 5 years clinical research experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting
Excellent verbal, written communication skills and interpersonal and presentation skills are required
Experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations. Experience with email and calendar programs. Experience with IVRS and EDC systems a plus
Knowledge of clinical research operations, FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well defined instructions and procedures
Ability to develop tools and processes that increase measured efficiencies of the project
Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, and organization tools
Strong attention to detail and excellent organization skills
Strong interpersonal skills and communication skills (both written and oral) able to work effectively in a team/matrix environment
Experience in gene therapy and/or rare disease indications preferred

Clinical Trial Manager Resume Examples & Samples

Supervise all CRM Department of Clinical Trials (DCT) contract employees
Act as a mentor; conduct training, counseling and annual evaluations for CRC staff and the support staff supervisor
Assess staff and investigator compliance with FDA and Army regulations, and Good Clinical Practice (GCP) guidelines
Track credentials and training requirements
Review clinical research protocols in order to plan staffing needs
Pre-review incoming clinical protocols for compliance and logistical issues
Schedule incoming protocols for space and staffing; assign CRCs, storage of study product and specimens as required, overlap of study requirements related to staff and study volunteer flow through the clinic
Oversee the DCT calendar to ensure optimal planning and execution of clinical research protocols
Liaison with other study personnel outside of the DCT, including but not limited to study sponsors, clinical research monitors and research laboratory staff
Work closely with CRM TMB Liaison and Program management to ensure necessary subcontract and business agreements are procured for study execution
Schedule and assist in monthly DCT Staff meeting, attend the monthly Translational Medicine Branch (TMB) meeting, facilitate site initiation visits (SIV) and walkthroughs for incoming protocols
Review, revise and approve standard operating procedures (SOP) as appropriate. Assign staff to SOP review and creation
Manage Emergency cart assignments, and resupply
Assist or conduct VIP tours of the Clinical Trials Center (CTC)
Function in any role within the DCT, to include but not limited to CRC, phlebotomist, recruiter, and administrative assistant
Provide technical assistance to CRM Headquarters as needed and participate on proposal writing projects when requested
Provide all job-related progress reports/technical reports as requested
Supervise direct reports as assigned by CRM. Approve timesheets and leave requests for all CTC CRM staff
Must be a currently licensed registered nurse (RN) with a minimum of 5 years of clinical research experience, and proven ability to multi-task
Must be able to work both independently and in a team setting
Must have excellent communication, organization, and prioritization skills
Intermittent physical activity including bending, reaching, and prolonged periods of sitting and or standing
Incumbent may be required to work at any facility and be responsible for own transportation
Incumbent will be scheduled based on operational and business needs
Required Knowledge, Skills and Abilities; knowledge of applicable highly complex scientific procedures and techniques relating to position
Physical Capabilities: work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material
Work Environment: Clinic/laboratory environment; may require working evenings and weekends
Must be able to work independently and mentor other Clinic staff
Basic Life Support (BLS –CPR/AED) certification
Advanced Cardiac Life Support (ACLS) certification encouraged
Maintain Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA)

Clinical Trial Manager Resume Examples & Samples

Master’s or PhD with experience in hematology or immunology research; OR
PharmD, BSN, Nurse Practitioner, or Physician Assistant with clinical experience in hematology or immunology
This position is office based in Cincinnati, Ohio

Clinical Trial Manager Resume Examples & Samples

BS Degree in Nursing, Life Sciences, or related health field and 4 - 8 years relevant experience
Experience supporting INTERNATIONAL clinical trials
Knowledge of clinical trial fieldwork concepts and practices, specifically international clinical research guidelines related to site management requirements
Ability to apply different standards related to clinical research (SOPs, GCP, ISO, ICH, FDA, etc.) as needed
Extensive knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines
Experience overseeing subcontractors such as CROs, central labs, and clinical sites
Outstanding organizational skills with the ability to multi-task and prioritize
Ability to build constructive and effective relationships; use diplomacy and tact
Ability to interpret regulatory and contractual documents
Experience with infectious disease or vaccine trials
Proficient in Spanish or Portuguese
Willingness to travel up to 25%
Certified Clinical Research Associate or Certified Clinical Research Professional
Experience with Good Laboratory Practice or Good Manufacturing Practice
Experience supporting US Govt-funded trials
Knowledge of and experience in trial protocol development
Certified Project Management Professional
Summer referral eligible

100

Clinical Trial Manager / Lead CRA Resume Examples & Samples

Plans and coordinates all assigned activities of study execution in accordance with planned trial milestones and budgets. This includes on site monitoring, site selection, regulatory document collection, site initiation, site monitoring, data management, coordination of external parties such as central laboratories, and site close outs
Leads cross-functional efforts to generate study specific documentation and templates including protocols and informed consent forms
Primary point of contact for the study, and manages day-to-day communications and activities of the study team - both internal and external team members, vendors and corporate partners
Participates with vendor selection, assists in the development of the scope of work, and ensures effective tracking of study progress, data quality and vendor performance based on pre-specified metrics
Ensures appropriate transfer of documentation and maintenance of the Trial Master File and any applicable databases

101

Senior Clinical Trial Manager Resume Examples & Samples

Site selection, enrollment, monitor study progress a. Coordinate the data collection and prepare/ drive the site selection decision process b. Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level. Ensures the availability of robust recruitment/contingency plans are in place for each region c. Ensures timely and accurate documentation and communication of study progress and issue escalation
Financial planning and tracking a. Set-up country budgets and monitor actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend. b. Ensures accurate budget management for assigned trials, including the budget updates in line with scope & follows up on budget variances. This includes ensuring vendors and affiliate budgets are tracked according to plan. Updates are made to proactively account for scope changes
Document development a. Creates and updates study-specific documents such as Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents. Provide input into cross functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan
Training and Investigator Meeting a. Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed. b. Responsible for the set-up and coordination of Investigator Meetings
Cross functional Study Management a. Act as the primary contact person for the local teams within GCDO. Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit. b. Demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledge
Continuous Quality Focus a. Ensure compliance with global Health Authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal audits. b. Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness. c. Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools
Data Cleaning a. Coordinate data cleaning independently towards a timely and successful database lock

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Clinical Trial Manager Resume Examples & Samples

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