Clinical Trials Manager Resume Samples

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K Pouros

Kattie

Pouros

1243 Christy Rue

Philadelphia

+1 (555) 760 7462

1243 Christy Rue

Philadelphia

Phone

p +1 (555) 760 7462

Experience Experience

Houston, TX

Clinical Trials Manager

Houston, TX

Dickinson, Larson and Batz

Houston, TX

Clinical Trials Manager

Assists with developing quality control mechanisms to ensure accurate data reporting. May assist with database development and CRF accuracy and implementation
Provides clinical input for new product development, post market surveillance, recertification and business development
Identify, establish, support, and develop relationships with key clinical and non-clinical decision-makers
Analyze new regulations and guidelines and proactively makes process improvement recommendations
Manage the day to day activities of the physical archive which may include the management of contractors and support staff
Determines and regulates research staff workloads and protocol assignments; serves as a link to principal investigators in management of staff
Provides clinical input to product development activities

Philadelphia, PA

Lead Clinical Trials Manager

Philadelphia, PA

Stehr-Koch

Philadelphia, PA

Lead Clinical Trials Manager

Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects
Initiate improvements, tools, processes, and forms to enhance the efficiency and the quality of work of Phase 2/3 Data Operations
Leads a team of Clinical Trial Managers and /or Data Coordinators and reports issues/concerns to Data Operations Manager
Meets with physician lead to provide necessary updates
Maintains case report forms tracking management database
Assists sponsor and US FDA audit teams
Assists in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events

present

Boston, MA

Senior Clinical Trials Manager

Boston, MA

Auer-VonRueden

present

Boston, MA

Senior Clinical Trials Manager

present

Assists in all aspects related to the management of clinical trial data
Assists in development of study-related documents including CRFs, IBs, PMs, ICFs, CSRs, SOPs
Provides study specific training of CRO staff, monitors, investigational sites, and other vendors
Assist in planning and managing investigator meetings, other trial specific meetings, KOL meetings in the assigned region
Manages and oversees the conduct of various tasks carried out by the Contract Research Organization
Participates and manages all aspects of assigned clinical studies from the planning stage to close-out
Manages multiple Haemonetics Sponsored and Investigator Sponsored Trials simultaneously across the assigned region/geographies

Education Education

Bachelor’s Degree in Biology

University of Washington

Bachelor’s Degree in Biology

Skills Skills

Ability to communicate conceptually detailed and complex information effectively and professionally with a wide range of people
Able to demonstrate professional knowledge within clinical trials management to give advice and guidance to internal and external customers
Knowledge of Quality Assurance/Quality Control processes
Demonstrates strong oral and written communication skills including the ability to prepare training material, administrative guides and manuals#LI-AO1
Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCP)
Provides knowledge and expertise on country specific regulations, site experience, and suitability for development studies
Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists
Strong customer focus with the ability to communicate effectively, both verbally and in writing
Demonstrated knowledge of clinical research concepts, good clinical practices and regulatory compliance
Ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations

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Clinical Trials Manager Resume Examples & Samples

5-7 years of professional experience
Fundamental understanding of clinical development principles, theories and concepts and knowledge of pharmaceutical industry practices and standards
Familiarity with the lifecycle of a clinical trial: from protocol development and feasibility through study close-out and reporting
Ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations

Senior Clinical Trials Manager Resume Examples & Samples

5+ years industry experience in Pharmaceutical, Biotechnology or CRO
3+ years of site management experience
2+ years of clinical experience with therapeutic area or disease preferred

Clinical Trials Manager Resume Examples & Samples

Prior experience in clinical trial management and/or regulatory compliance strongly preferred
Prior experience in a medical or science-related setting preferred
Previous experience with patient-oriented research preferred

Clinical Trials Manager Resume Examples & Samples

Assure adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), and other pertinent regulatory agencies
Assign coordination of specific clinical trials to yourself and the clinical research coordinators (CRC); ensure staffing during vacations and other absences
Supervise and monitor the performance of the clinical research coordinators
Conduct semi-annual performance reviews of the CRC staff. Take appropriate action if required to improve performance after consultation with the Research Administrator
Assure staff and investigator training on and adherence to Department of Radiology clinical trials SOPs; maintain and update these SOPs
Perform clinical trial initiation procedures including preparation and negotiation of study budgets, submission of confidentiality and clinical trials agreements to the Office of Grants and Contracts, regulatory document submissions and site initiation visits
Recruit and interview prospective subjects for clinical studies and educate potential subjects about the details of the study through phone contacts, personal interviews, and informed consent
Schedule subject visits and coordinate all personnel required for the visits
Collaborate with clinical staff in the hospital to ensure tests and procedures are scheduled and performed correctly; provide an initial orientation to new study protocols
Assure compliance with protocol requirements and complete necessary records. Accurately transfer source documentation into electronic Case Report Forms (CRF). Maintain all clinical research patient files
Recognize adverse and serious adverse events, and provide prompt notification to the appropriate parties
Prepare documentation for sponsor monitoring visits and FDA audits
Enhance research growth within the Radiology faculty by providing focused education programs including topics such as the IRB submission process and the availability of research resources
Educate new investigators and staff about clinical research regulatory and data collection requirements
Identify appropriate clinical trials for Radiology participation and facilitate faculty involvement
Oversee coordination of the tumor measurement and protocol review services and ensure adequate coverage during vacations and other absences
Develop study budgets, negotiate budgets with trial sponsors and submit them to the Office of Grants and Contracts
A Master’s degree and a minimum of 3 years of experience in clinical research
Experience with industry sponsored clinical trials
Knowledge of Good Clinical Practice guidelines and FDA regulations
Experience with sponsor and/or FDA audits of clinical trials
Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task
Demonstrated knowledge of basic human anatomy, physiology, medical terminology, and computers
HIPAA and human subjects’ certifications
Experience with NIH sponsored clinical trials
Knowledge of study budgeting and billing processes
Experience working in the EPIC electronic medical record system
Experience working in the OnCore research management system

Clinical Trials Manager Resume Examples & Samples

Facilitates communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management, Key Opinion Leaders/investigators and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff (BPT/PIB, etc.)
Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines
Facilitates 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, Ethics Committees, etc. May include clinical risk management activities including input into DFUs and authorship of Clinical Evaluation Report (CES, CRBA, CDSR) in support of the safety and performance of products
Bachelor’s degree and 8+ years of related work experience or an equivalent combination of education and work experience
Ability to apply comprehensive technical knowledge of a particular field to resolve complex issues in creative ways
Cardiac Rhythm Management (CRM), electrophysiology Clinical trial or technical experience desired
level of position will be determined by candidate’s experience

Senior Clinical Trials Manager Resume Examples & Samples

Must meet all requirements for Senior Clinical Research Associate position and have demonstrated proficiency in all relevant areas
Coordinating and supervising all aspects of a clinical study. Monitors clinical trial sites
Assists Clinical Program Manager in overall study management
Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports
Contributes to development of RFPs and participate in selection of CROs/vendors
Manage CROs/vendors
May contribute to development of abstracts, presentations, and manuscripts,
Ensures effectiveness of site budget/contract process
May be asked to train CROs, vendors, investigators, and study coordinators on study requirements
Assists in determining the activities to support a project�s priorities within functional area
Travel is required
Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
Must be able to generally understand, interpret, and explain protocol requirements to others
Must be able to prioritize multiple tasks
Under general supervision, is able to examine functional issues from an organizational perspective
6+ years of experience and a BS or BA in a relevant scientific discipline
6+ years of experience and an RN (2 or 3 year certificate)

Clinical Trials Manager Resume Examples & Samples

Serves as the key operational contact with external investigators and internal stakeholders, for successful implementation of Gilead (GS), Collaborative (CO), Investigator Sponsored Research (ISR) Studies, expanded access programs, and compassionate use programs
Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for Late Phase research management
Provide support and guidance, as required, to Affiliate Clin Ops & Medical Affairs personnel responsible for managing CO and ISR studies
Maintains a good understanding of industry standards for CO and ISR studies and keeps abreast of any new changes and developments which could impact Late Phase research operations
Prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions
Able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions
Participate in or manage project meetings and conference calls with CROs, vendors, and multi-functional teams
Participate in abstract presentations, oral presentations, and manuscript development activities
Assist in review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
Conduct site evaluation, initiation, co-monitoring, and closeout visits, in addition to the routine monitoring visits
Excellent verbal, written, interpersonal and presentation skills are required

Senior Clinical Trials Manager Resume Examples & Samples

Manages successful implementation of Gilead (GS), Collaborative (CO), Investigator Sponsored Research (ISR) Studies, and expanded access programs, and compassionate use programs
May present the outcomes of the assessments to proposal review committee members
Establishes strong partnerships with external investigators, collaborators, and internal stakeholders to ensure efficient execution of the study management processes
For GS studies, ability to write study protocols, study reports, and regulatory documents (e.g. IND, NDA, etc.) with little supervision
Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction
Provide guidance and training to CROs, vendors, investigators and study coordinators on study requirements
Coaches members of a work team and ensures adherence to established guidelines
Ability to examine functional issues from a broader organizational perspective
Collaborates with local medical affairs colleagues on country specific studies and initiatives
Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
Must meet all requirements for CTM and have demonstrated proficiency in all relevant areas
At least 6+ years of experience and a BS or BA in a relevant scientific discipline
At least 6+ years of experience and an RN (2 or 3 year certificate)

Clinical Trials Manager Resume Examples & Samples

Protocol/amendment development (including review of all applicable literature such as SBAs, FDA guidance’s, and other publications)
CRF design, modification/creation of ICF, Investigator Brochures, presentations and training materials
Study related forms/reports and source documents in collaboration with the CRO and development of submission materials for FDA review and consideration
A Bachelor's in a Scientific discipline is required. An Advanced Degree is preferred
A minimum of five to seven (5-7) years of professional experience within Clinical, Regulatory or another Scientific field is required; at least two (2) years of CRA experience is highly desired
Complete understanding and wide application of technical standards, principles, theories, and concepts in the field
Advanced computer proficiency in Word, Excel, PowerPoint and MS Project
Knowledge/mastery of Federal regulations and Clinical guidances
Demonstrated advanced skills in decision making, problem solving, and risk mitigation planning
The position requires substantial responsibility for strategic planning, design, implementation and follow-through of decisions/tasks dictated by Project, Project Team and/or Business unit
This position requires about 15-25% travel to investigational sites, other Perrigo locations and Contract Research Organizations (CROs)
Experience in dermatology, women’s health, respiratory, Gastro-intestinal, NDA and/or bio-equivalence trials is preferred, but not required
Note this role can sit in either Bronx, NY or Parsippany, NJ, depending on the candidate's preference.**

Associate Clinical Trials Manager Resume Examples & Samples

Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in biology, clinical research, project management or related field or four (4) years related experience in lieu of degree
A minimum of four (4) years of progressively responsible experience in a clinical trials/research and/or project management environment, including a minimum of two (2) years of directly related to overseeing multiple concurrent protocols
Onsite monitoring experience for IND and/or Investigational Device Exemption (IDE) studies
Ability to work in a busy clinical research management setting, both independently and within a team
Excellent oral and medical/technical writing skills
Proficiency in Microsoft Office Suite including Project, Visio, and PowerPoint
Ability to communicate effectively with program leaders
Strong interpersonal, leadership, and analytical skills
Ability to demonstrate good judgement and decision making, attention to detail, and personal accountability
Ability to effectively handle multiple tasks and priorities
Ability to create and maintain a full spectrum of clinical trials program/project management documents
Thorough understanding of the clinical research environment
Ability to maintain a collaborative working relationship with site PIs, study staff and Clinical Research Organizations (CROs)/outside monitors
Knowledge of clinical trial fieldwork monitoring concepts and practices including on site monitoring requirements, FDA and IND regulations, and GCPs
Knowledge of conducting federally funded studies
Certified clinical research professional (CCRP)
Familiarity with regulatory requirements and guidelines for facilitating clinical human subjects research
Knowledge of Data Management Systems
Knowledge of QA/QC processes
Certified Project Management Professional (PMP)

Data Management Clinical Trials Manager Resume Examples & Samples

Capable of interacting effectively with scientists and managers within and outside CSO SCP; serve as internal consultant on assigned area and liaise with external organizations on projects
Strong Project Management and planning skills
Excellent decision-making and problem-solving skills

Clinical Trials Manager Resume Examples & Samples

Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/clinical trials/health or four (4) years related experience in lieu of degree
A minimum of six (6) years related experience in a pharmaceutical, biotechnology and/or clinical environment
Clinical trial project management experience
Experience in preparing site management budgets
Proficiency in all functions of clinical research implementation processes and conduct
In-depth knowledge of the clinical trial and drug development process
Experience in data management and subcontracting
Ability to work in a clinical research setting both independently and within a team to coordinate, negotiate, and facilitate data
Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCP)
Knowledge of clinical trial fieldwork concepts and practices
Strong customer focus with the ability to communicate effectively, both verbally and in writing
Strong problem solving, planning and organizational skills
Ability to prioritize multiple tasks and projects
Cancer and infectious disease research experience
Knowledge of Quality Assurance/Quality Control processes
Knowledge of site selection activities and tracking site capabilities
Progressively increasing clinical site monitoring/auditing experience, management of multiple concurrent clinical trials/projects and supervisory experience

Clinical Trials Manager Resume Examples & Samples

Bachelor´s degree (Advanced degree preferred) or equivalent education and experience
A minimum of 8 years of Clinical Trials experience for diagnostic, medical device or pharmaceutical products
A solid understanding of project management and familiar with project management tools
Knowledge of pathology and/or oncology is preferred
The ability to organize and motivate others

Clinical Trials Manager Resume Examples & Samples

Must meet all requirements for Sr. Clinical Trials Management Associate position and have demonstrated proficiency in all relevant areas
Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility and fair market value assessment
Establishes strong partnerships with external investigators and collaborators to ensure ongoing activities (e.g. sponsor updates, drug shipments, publications, milestone payments, etc) for CO and ISR studies are executed in a timely manner and with high quality
Establishes strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams (e.g., CSM, CCF, DSPH, and Medical Affairs) to ensure efficient execution of the study management processes
Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure study remains on track
Implements and maintains working processes to promote high quality, efficient, and compliant systems and tools for CO and ISR study management
Maintains a good understanding of industry standards and regulations for CO and ISR studies and keep abreast of any new changes and developments impacting Late Phase clinical operations
Organizes and leads clinical operational meetings
For GS studies, drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, and clinical study reports
Must be able to understand, interpret and explain protocol requirements to others
Maintains study timelines
For GS studies, contributes to development of RFPs and participates in selection of CROs/vendors
For GS studies, may be asked to train CROs, vendors, investigators and study coordinators on study requirements
Contributes to development of study budget
Participates in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development
Under supervision, may design scientific communications within the company
Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
Must have a general, functional expertise to support SOP development and implementation
Provides knowledge and expertise on country specific regulations, site experience, and suitability for development studies
Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
At least 5+ years of experience and a BS or BA in a relevant scientific discipline
At least 5+ years of experience and an RN (2 or 3 year certificate)

Clinical Trials Manager, Beijing Resume Examples & Samples

Manages the China regional clinical trial and independently manages all components of a small less complex studies and phase 1 studies
Manages vendors and maintains cross functional study timelines in partnership with global study team
Partners with global study team and CRO to troubleshoot country/site specific operational issues
Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
Coordinates review of data listings and preparation of interim/final clinical study reports
Assists in determining the activities to support a project’s priorities within functional area
Contributes to development of RFPs and participates in selection of CROs/vendors
May be asked to train CROs, vendors, investigators and study coordinators on study requirements
Able to examine functional issues from an organizational perspective
Establishes good relationship with key institutions and key investigators in the region
Conducts co-monitoring/oversight and relationship building visits in the region as required
Contributes to development of study budget and ensures effectiveness of site budget/contract process in the region
Collaborates with local medical affairs colleagues on country specific studies and initiative
Provides knowledge and expertise on country specific regulations and site experience and suitability for development studies
May serve as a resource for others within the company for clinical trials management expertise
Participates in the recruiting and hiring process for CPAs and CTMAs and supports their professional development
Contributes to SOP development, implementation and training within the department as required
Mentors junior team members and may contribute to employee performance management
Must have 6+ years of experience in the clinical trial industry and a BS in a relevant scientific discipline
Must have 1+ year project management experience in China
Must have 3+ years site monitoring experience in China
Thorough knowledge of FDA/CFDA/the Chinese Regulatory Regulations, ICH Guidelines, and GCP/China GCP governing the conduct of clinical studies
Must meet all requirements for Sr. CTMA position and have demonstrated proficiency in all relevant areas
Prior experience in working in both pharmaceuticals and CROs is preferred
Advanced project management skills adequate to manage the entire process of a clinical trial
Ability to identify issues and adapt to changes
Will incorporate study logistics and planning to accomplish
Ability to work independently with minimal oversight
Ability to lead cross-functional teams internally and externally and mentors team members
Excellent teamwork, communication, decision-making and organizational skills are required

Lead Clinical Trials Manager Resume Examples & Samples

Have understanding of clinical trial data
Knowledge of FDA guidelines and GCP
Able to analyze clinical trial data
Professional writing and communication skills
Organizational and prioritizing capabilities
Computer skills with demonstrated ability using clinical trial database, electronic data capture, MS Access or Excel
Detail oriented and meticulous
Experience in healthcare, research or other science related field
Experience in planning and managing clinical trial process

Clinical Trials Manager Resume Examples & Samples

Manage the day to day activities of the physical archive which may include the management of contractors and support staff
Oversee the development, implementation and maintenance of systems key to CDE Archiving
Has solid technical and analytical skills and is able to recommend changes to or troubleshoot systems
Revise strategy for and closely manage CRO/Partner record migrations
Work as part of TMF Compliance and Oversight team to implement and maintain an eTMF ensuring appropriate archiving processes are in place
Manage compliance activities for internal and external inspections and audits
Independently solve problems of high degree of complexity with limited supervision
Represent CDE Archive in review of procedures and processes to identify gaps and revise accordingly
Analyze new regulations and guidelines and proactively makes process improvement recommendations
Prepares and delivers effective presentations for internal audiences, as needed
Participates in and at times leads discussions regarding CDE Information Management strategy
Gather’s metrics on specific tasks and technical aspects for management updates
Has demonstrated competence in a supervisory role
Demonstrates an in-depth understanding of applicable regulations
Proven ability to design and/or execute procedures and communicate those procedures to others
Displays ability to influence within technical area of expertise
Proven ability to manage projects of moderate scope and complexity
Exhibits moderate understanding of technical disciplines beyond own specialty area
Proactively identifies and resolves problems
Demonstrates strong oral and written communication skills including the ability to prepare training material, administrative guides and manuals#LI-AO1
B.S. (or equivalent degree) and 6+ years relevant work experience

Clinical Trials Manager Resume Examples & Samples

Provides clinical data management support
Participates in the review of clinical research documents (for example, Protocols, Case Report Forms, Reports and Statistical analysis)
Reconciles electronic data transfers of site data to sponsor
Performs maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trials (for example, compiling master user lists and activating/deactivating user accounts)
Performs training on study trial for EDC and create user guides
Ensures clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock (for example, data reconciliation and/or coding)
Assists in defining and/or create data listings, summary table validation, data specifications and/or processes data transfers in preparation for statistical review and/or data management audit
Coordinates the archiving of study databases and related documents
Performs close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs
Coordinates and communicates with DB vendors on consistent basis to address Clinical teams' requests, project plans, and/or eCRF development activities
Collaborates with IT and implementation team(s) to address Clinical application requests and/or changes to clinical database systems
Participates in the preparation and presentation of data, including original research project to be presented in 2017-2018 calendar year

Clinical Trials Manager, Oncological Sciences Resume Examples & Samples

Manages and coordinates clinical trial research studies conducted by a principal investigator to ensure conformance with specified research objectives and protocols
Coordinates and establishes clinical trials schedules, task delegation, and allocation of staff and equipment
Oversees handling of all subjects enrolled in clinical trials; tracks regulatory documents for clinical trials
Ensures clinical research studies are conducted according to regulatory requirements, good clinical practices and specified research protocols, including those of the Icahn School of Medicine at Mount Sinai, outside sponsors and federal and/or state regulatory agencies
Monitors and reconciles the budget for all clinical trials; ensures payments from the sponsoring agency are received in a timely manner
Organizes grant submissions and implements standard operating procedures for clinical monitoring; manages and monitors sites involved in clinical trials including the recruitment and management of subjects
May assist in various personnel functions such as hiring, performance appraisals, coaching, disciplinary actions and terminations
Provides guidance and support to staff and orients and mentors new research team members

Clinical Trials Manager Resume Examples & Samples

Manages and coordinates assigned clinical trial research studies conducted by a principal investigator to ensure conformance with specified research objectives and protocols
Serves as liaison for clinical trials conducted for pharmaceutical companies. Provides status reports, adverse side effects and trends, evaluates patient enrollment and provides appropriate recommendations and/or conclusions
Assists with the development of operating policies and procedures for clinical trials; conducts meetings with staff to ensure compliance with established practices and to keep employees abreast of current changes and standards
Organizes grant submissions and implements standard operating procedures for clinical monitoring. Manages and monitors sites involved in clinical trials including the recruitment and management of subjects
May assist in various personnel functions such as hiring, performance appraisals, coaching, disciplinary actions and terminations. Provides guidance and support to staff and orients and mentors new research team members
Bachelor's Degree in Biology, Public Health or related scientific/health field; Masters preferred
1 year in a management/leadership role
Demonstrated knowledge of clinical research concepts, good clinical practices and regulatory compliance
Proven ability to provide scientific and clinical expertise in all phases of clinical trials
Strong management and leadership skills

Clinical Trials Manager Resume Examples & Samples

Collaborate with principal investigators and clinical team in conduct of both investigator initiated IND studies and externally sponsored clinical trials
Supervise and mentor a rapidly growing team of 20+ study staff, including Research Nurses, Clinical Research Coordinators, Regulatory Coordinators, and Data Coordinators
Responsible for the recruitment and training of full-time research staff, conduct annual performance reviews of full time study staff
Defines and oversees the roles and responsibilities of research staff members to ensure effective work coordination of research activity between study staff and principal investigators. Creates clear plan for staffing of both industry and investigator initiated studies, ensures cross-coverage and responsiveness to a highly dynamic environment; plans for future growth needs all staff areas
Determines and regulates research staff workloads and protocol assignments; serves as a link to principal investigators in management of staff
Collaborates with investigators and evaluates protocols to anticipate and plan for future staffing needs
Assists with developing quality control mechanisms to ensure accurate data reporting. May assist with database development and CRF accuracy and implementation
Assures subject data is collected, organized, and submitted in a timely manner
Assures that regulatory submissions are completed, organized, and submitted in a timely manner
Assures collection of biological samples and safe conduct of these studies with the clinical team
Provides protocol management and research expertise by participating in discussions pertinent to projects at collaborative research meetings
Identifies operational, logistical, and regulatory challenges related to the conduct of clinical trials and work flow within the research group and act as the leader in their resolution
Develops and implement procedures that strengthen the conduct of clinical trials and ensures adherence to SOPs, GCP, and FDA guidance
Coordinates and participates in monitoring visits, audits, and other compliance reviews to ensure compliant conduct of research
Responsible for coordination between clinical team at the Bezos Family Immunotherapy Clinic at the Seattle Cancer Care Alliance and the Fred Hutch based clinical research team
Organizes projects and collaborates with multidisciplinary team, including finance, GMP manufacturing, business development, clinical staff, and others as needed to complete assigned tasks. Attends regularly scheduled conferences and meetings
Collaborate with investigators on development of a long-term follow up program for cell therapy
5-10 years combined coordinating or managing oncology clinical research required
Familiarity with both IND and sponsored clinical trial design and management; experience with investigator initiated IND trials preferred
At least 3 years supervisory experience required; experience managing large teams is preferred
Bachelor's degree required, Master’s preferred
Clinical Research Certification (CCRP, CCRC) preferred
Knowledge of GCP and ICH guidelines, FDA regulations, and Clinical Research Policies including Data Management, Quality Assurance, Clinical Trial Coordination and Monitoring
Problem-solving abilities to analyze situations, draw conclusions, make recommendations and convey this information in a timely and proficient manner
Excellent organizational and financial management skills

Clinical Trials Manager Resume Examples & Samples

Serves as one of the CMRP project leads
Assists with the planning and implementation of clinical trials
Participates in managing and coordinating project activities for the Zika Phase IIB clinical study (and others)
Acts as a liaison between various Leidos Biomed, NIAID entities and collaborating offices, interacting with both scientific and administrative officials
Coordinates and communicates efforts within the assigned activities to include organizing, planning, executing, reporting and evaluating the assigned program objectives
Collaborates with Clinical Research Organizations (CROs) on site management activities
Identifies and assesses clinical trial sites and the necessary infrastructure to carry out clinical studies domestically and internationally, including: clinical site assessment, clinical site preparation, clinical site training and clinical site logistical support
Coordinates meetings between various CROs and clinical sites
Provides mentoring, leadership and supervision to other staff
Reviews sponsor protocol edits and Informed Consent Forms (ICF) edits, case report forms, study templates and manual of operations
Reviews site audit reports prior to and upon completion
Assists with CMRP site audits as needed
Oversees site management activities
Travels up to 20%
Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/clinical trials/health (Additional qualifying experience may be substituted for the required education)
In addition to educational requirements, a minimum of eight (8) years of progressively responsible relevant experience in clinical research including a minimum of three (3) years directly managing multiple concurrent clinical trials
International clinical trials experience
Experience in preparing and managing site management budgets
Infectious disease and vaccine research experience
Ability to read, speak, and write – Latin American Spanish and/or Brazilian Portuguese

Clinical Trials Manager Resume Examples & Samples

Responsible for global management of current clinical trials and process improvements
Serve as the liaison to the CRO, which includes creation and tracking of timelines, vendor management and oversight, regular communication, identification and escalation of issues, and coordination with internal departments
Support new product launches, including assisting with creation of training materials/programs, presentations, and ongoing field support
Serve as an expert in their assigned disease state and clinical landscape, and therefore act as a resource for assisting in commercialization efforts and strategy
Serve as a resource for the medical device Product Manager: create pipeline for devices, manage CAPAs, kitting, engineering, vendors, site equipment program, and track complaints
Perform field market analyses and help identify future opportunities
Analyze the SUI/Uro market frequently to be able to provide expert opinion on future business strategy
Identify, establish, support, and develop relationships with key clinical and non-clinical decision-makers
Represent Cook MyoSite as the expert on the product, procedures, clinical trials, clinical landscape, disease state, anatomy, and processes
Develop an understanding of the complex scientific concepts regarding the product and proposed mechanism of action in order to comprehend highly detailed scientific data and scientific publications
Provide clinical experience and feedback to Product Development, Marketing, Product Logistics, Field Product Specialist, and Clinical Team
Present updates and business plans to Manager and stakeholders
Bachelor’s degree in Natural Science, Nursing, Regulatory Affairs, or Business required
3 years of experience with project or program management required
2 years of experience working for a CRO or as a Research Coordinator preferred
CCRP, CCRA, or CCRC certifications preferred
3 years of experience in a clinical environment with procedure support preferred
Must have an understanding of the regulations and rules associated with cGCP, cGMP, and 21 CFR
Must have exceptional communication skills
Must have experience with vendor management

Clinical Trials Manager Neurosurgery Days Msh Resume Examples & Samples

Coordinates and establishes clinical trials schedules, task assignments and allocation of staff and equipment
Coordinates and manages all subjects enrolled in clinical trials, completion of data for Case Report Forms (CRF), drug accountability and the completion and tracking of regulatory documents for clinical trials
Ensures clinical research studies are conducted according to regulatory requirements, good clinical practices and specified research protocols, including Mount Sinai School of Medicine, outside sponsors and federal and/or state regulatory agencies
4 years of experience managing clinical trials
Excellent written, oral and interpersonal skills

Clinical Trials Manager Resume Examples & Samples

Demonstrated expertise in relevant clinical operations activities
Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results
Good organization and planning skills
Ability to problem solve and delegate appropriate tasks to subordinates
Strong leadership skills, self-motivated, adaptable to a dynamic environment
Ability to collaborate effectively with the study team, cross-functional team members, and external partners
Knowledge of ICH/GCP and FDA regulations
Proficiency in MS Word, Excel and PowerPoint

Clinical Trials Manager, South Africa Resume Examples & Samples

Ensure efficient protocol start-up & implementation at study sites by facilitating or liaising between sites, other functional units within the HVTN, the developer, the sponsor, and others as needed. Manage expectations for HVTN and sites related to study implementation, including the start-up timeline, enrollment, and site performance
Assess study site staff training needs, prepare protocol-specific training and study materials for study site use. Develop, interpret, and administer project/study policies and procedures according to protocol, ethics committee, grant/contract, data management center, laboratory program and Fred Hutchinson Cancer Research Center specifications
Set project goals and drive implementation timelines to ensure that all implementation activities are completed on time. Ensure clear internal cross-unit collaboration and communication, including identification of milestones, issues & resolutions
Represent and advocate for sites in strategic & operational discussions. Serve as the primary “go-to person” for site knowledge and site-related queries
Drawing on knowledge and relationships with sites’ operations, provide input to protocol teams on site expertise and potential obstacles and challenges
Along with a team of Clinical Trials Managers based in Seattle, represent the protocol team in developing, reviewing, and/or revising research materials including SOPs, questionnaires, data collection instruments, educational materials, and recruitment materials. Develop content of data collection instruments, as negotiated with the data center and protocol team, on a protocol-by-protocol basis
Serve as the first point of contact when problems pertaining to a particular protocol and/or site arise. Develop plans for addressing deficiencies at study sites in collaboration with protocol team and sponsor
Coordinate development of new sites. Assess capacity of study sites to conduct research protocols in accordance with network SOPs, sponsor requirements, and principles of Good Clinical Practice. Coordinate site space and equipment planning and utilization, evaluate current project/study needs, anticipate future needs, and oversee acquisition of space/equipment
Plan and attend committee meetings, monitor activities to ensure objectives have been met within designated time frame, and coordinate follow-up activities
Degree or equivalent in public health, life sciences or nursing or related field plus a minimum of 7 years of relevant experience in project management, study management or clinical trial management in Africa. Masters’ degree or equivalent preferred. A combination of education and experience may be considered
Experience working on a team with a wide range of education and experience
Understanding of clinical trial conduct in limited resource settings
Ability to identify and communicate trial conduct issues and facilitate resolution between research collaborators and study sites quickly and effectively
Capable of establishing priorities and managing multiple concurrent projects in order to meet project timelines
Familiar with GCP
Highly motivated, self-starter, and able to work independently
Ability to work well with colleagues and as part of a team
Willing to travel as required
Flexibility and a sense of humor are essential

Senior Clinical Trials Manager Resume Examples & Samples

Manages and oversees the conduct of various tasks carried out by the Contract Research Organization (CRO)
Provides study specific training of CRO staff, monitors, investigational sites, and other vendors
Assists in development of study-related documents including CRFs, IBs, PMs, ICFs, CSRs, SOPs
Reviews Monitoring Reports or conducts Monitoring if needed for the program
Tracks CRO tasks, expenditures and timelines
Assist with the review of appropriate sites and site selection as well as TMF set-up as necessary
Participates and manages all aspects of assigned clinical studies from the planning stage to close-out
Manages multiple Haemonetics Sponsored and Investigator Sponsored Trials simultaneously across the assigned region/geographies
Oversees adherence to subject recruitment goals, study timelines and participates in Gantt chart creation
Reviews and approves vendor invoices and manages payment processes and budgets
Coordinates and executes special projects as appropriate
Ensured research activities comply with local regulatory requirements, Haemonetics’s SOPs, GCPs, and that audit readiness is maintained throughout trial conduct
Participate in the preparation of filings to regulatory agencies as needed
Maintains up-to-date knowledge by regularly reviewing the pertinent clinical/ scientific literature
Assists in all aspects related to the management of clinical trial data
Provides guidance and support on queries as needed
Participates in tracking and reporting of trial-related information in the internal navigational electronic database
Communicates study goals and timelines to internal and external stakeholders
Assist in planning and managing investigator meetings, other trial specific meetings, KOL meetings in the assigned region
Communicates with clinical site staff, investigators and CRO as appropriate to ensure optimal Sponsor-site relationships
Proactively identifies potential study risks/ problems and manages them in close collaboration with cross-functional teams

Clinical Trials Manager Resume Examples & Samples

Contributes to development of global business strategy through participation in the Franchise Leadership Team
Develops the global clinical strategy to support the Franchise business objectives, and designs the required studies, budgets and resource plans
Leads and directs clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures
Leads a team of Clinical Trial Managers and Specialists in the planning, execution and management of all operational aspects of clinical trials, including large-scale, complex, and/or business critical studies
Tracks development of and collaborates with the project teams on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions
Ensures the project teams maintain a continuous state of audit readiness
In collaboration with the Clinical Trial Managers and Specialists, leads the proactive identification, assessment, and management of clinical study risks
Provides clinical input to product development activities
Recruits, manages and develops Specialists, Principals and Fellows. Mentors and coaches all levels of the Clinical Trials team
Bachelor’s degree and 13+ years of related work experience or an equivalent combination of education and work experience
Project management / leadership experience required
People management experience required
Ability to maintain strategic perspective and align activities with business vision and purpose
Ability to guide, coach, direct, and develop direct reports, and support the development and implementation of action plans that align activities with project, program and business objectives
Oncology clinical trial experience

Clinical Trials Manager Resume Examples & Samples

Degree/NVQ 4 or equivalent Professional membership/experience and up to date Good Clinical Practice training
Substantial experience of working within clinical trials research
Able to demonstrate professional knowledge within clinical trials management to give advice and guidance to internal and external customers
Proven experience in developing new processes and procedures
Knowledge or interest in immunotherapy
Evidence of ability to explore customers’ needs and adapt the service accordingly to ensure a quality service is delivered
Proven ability to develop networks in order to contribute to long term developments
Evidence of demonstrable knowledge of key advances within immunotherapy research
Evidence of ability to undertake and deliver specific projects and supervise short term project teams
Postgraduate/Professional qualification
Experience of working in a Higher Education environment