Clinical Study Manager Resume Samples

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J West

Janet

West

72731 Jacynthe Club

Boston

+1 (555) 110 1455

72731 Jacynthe Club

Boston

Phone

p +1 (555) 110 1455

Experience Experience

Chicago, IL

Clinical Study Manager

Chicago, IL

Hoppe-White

Chicago, IL

Clinical Study Manager

Assist with development and execution of monitoring plan and monitoring oversight plan in collaboration with CPM and site management team
Create and report clinical study updates to management on a regular basis; report on performance to plan
Developing Study Reports and providing clinical portions for Regulatory submissions
Manage contracts with external parties (e.g., care networks such as CROI/HBT and GP surgeries)
Perform and supervise site initiation, site management, site monitoring, site close out
Work with Medical Writing and assigned Medical Director to develop clinical study protocols
Assisting with the management of medical device distribution, receipt, use and return

San Francisco, CA

Lead Clinical Study Manager

San Francisco, CA

McKenzie, Strosin and Brakus

San Francisco, CA

Lead Clinical Study Manager

Lead cross functional Study Execution Team, including functions, Strategic Partners and other vendors to ensure study goals are met, on time and within budget. Includes leading and organizing cross functional study team meetings
Management of Strategic Partners, including setting expectations, training, CRO Oversight process, Task Orders, Change Orders, invoice approval and financial reconciliation process for assigned study. Responsible as first point of contact for Issue Management process for assigned study. (Range: $750,000 (e.g. less complex Phase 1) to $250 million(large complex outcomes studies))
Contributes to protocol synopsis development and to Clinical Study Plan development, including Clinical Operations feasibility assessments
Leads the cross functional protocol development process, including responsibility for any protocol amendments or administrative changes
In collaboration with Study Execution Team (functions, Strategic Partners, and vendors), identify risks to study and develop risk mitigation plans, including communication and collaboration with Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning
Management of the study budget, including Task Orders, Change Orders, invoice approval and financial reconciliation process
May be asked to participate in issue management and risk mitigation for studies assigned to other Study Managers

present

Philadelphia, PA

Senior Clinical Study Manager

Philadelphia, PA

Prohaska-Thompson

present

Philadelphia, PA

Senior Clinical Study Manager

present

Manage and lead cross-functional study teams, including vendors
Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
Lead feasibility assessment and selection of countries and sites for study conduct
Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members
Clinical project management of a clinical study
Create and drive study level timeline
Develop overall feasibility concept and enrollment plan with input from COMs

Education Education

Bachelor’s Degree in Life Sciences

Syracuse University

Bachelor’s Degree in Life Sciences

Skills Skills

Builds positive relationship with principal investigators and site personnel under his responsibility
Fluency in both written and spoken Korean and English
Effective time management skills 
Ability to manage competing priorities 
Ability to establish and maintain effective working relationships with coworkers, managers and clients 
Excellent verbal and written communication, problem solving skills and team orientation
Superior organizational skills
Demonstrated performance management abilities
Extensive monitoring experience
Excellent judgment and decision making skills

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Clinical Study Manager Resume Examples & Samples

Performs all monitoring activities according to protocol monitoring plan and relevant WIs
Builds positive relationship with principal investigators and site personnel under his responsibility
Basic Knowledge of applicable clinical research regulatory requirements; i.e, Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines 
Effective time management skills 
Ability to manage competing priorities 
Ability to establish and maintain effective working relationships with coworkers, managers and clients 
Excellent verbal and written communication, problem solving skills and team orientation

Senior Clinical Study Manager Resume Examples & Samples

Manage and lead cross-functional study teams, including vendors
Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team
Participate in process improvement and quality-related initiatives associated with study execution and deliverables; participate in establishment of best-in-class processes and standards for study conduct
Provide oversight and direction to study team members for study deliverables; may provide direction to Clinical Study Managers, Associate Clinical Study Managers and Clinical Trial Associates for assigned studies

Senior Clinical Study Manager Resume Examples & Samples

A Bachelors degree in the Sciences is acceptable
Candidates with a nursing diploma/assoc degree with substantial experience may be considered for this position
5 years relevant experience is required with a BSc, 3 years with a MS/MPH, or 2 years with PharmD/PhD/MD
Clinical studies, global regulatory issues, CRO operations, and compliance practices
Interacts appropriately with high levels of internal and external stakeholders (e.g., CROs); focuses on developing and building strong relationships
Demonstrates appropriate level of understanding and application of internal and external compliance practices and global regulatory bodies and inspections
Demonstrates ability to manage all points of the clinical project, particularly complex projects
Supports and effectively multi-tasks different and complex assignments and responsibilities
Investigates and determines solutions to difficult, problematic situations; escalates issues as necessary
Effectively manages and leads study teams within the matrix of the organization; provides coaching and training
Sound understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development. Proficiency in computer applications such as Microsoft Word, Excel, and PowerPoint. Strong oral and written communication skills

Clinical Study Manager Resume Examples & Samples

Be passionate about managing clinical studies for state-of-the art implantable medical devices
Coordinating the activities of interdisciplinary Gore team members in the planning, executing and closing of clinical studies
Developing and approving study-specific documents, tools, presentations and processes
Delivering study related training
Selecting and coordinating DSMB/CEC/Steering Committees, when applicable
Preparing and presenting at Investigator meetings
Participating in the site qualification, study initiation and study closure process
Assisting with the management of medical device distribution, receipt, use and return
Routinely reviewing data/CRFs to ensure data integrity, accuracy and protocol compliance
Tracking and reporting progress of studies to applicable internal stakeholders including: patient screening, enrollment, data collection, adverse event documentation and reporting
Developing Study Reports and providing clinical reports for Regulatory submissions
Assisting in query writing and resolution process
Identifying and gathering missing or incomplete data from investigational sites
Conducting site visits, as necessary
Acting as a company liaison to work with clinical sites, Contract Research Organizations (CROs) and other vendors
Overseeing activities of site monitors, including reviewing and approving visit reports
Managing non-compliance for resolution and prevention
Budget forecasting and payment approvals
Maintaining familiarity with all applicable regulatory requirements and relevant clinical literature
Bachelor’s degree in a science/health related field and at least two years of experience in clinical research OR at least 5 years of clinical research in the medical device or pharmaceutical industry
Ability to positively influence associates, both internally and externally
Strong organizational skills, flexibility, and ability to multi-task
Experience working on cross-functional teams
Ability to work on a remote team
Travel as necessary to achieve business and project objectives (~25%)
4 years of experience in clinical research in the medical device or pharmaceutical industry

Clinical Study Manager Resume Examples & Samples

Passionate about and experienced in managing clinical studies
Ideally possessing a Bachelor's degree in a science or health related field
Experienced of working in cross-functional, virtual and international teams
Proactive, high attention to detail, highly organised, flexible and able to multi-task
Fluent English and Italian with strong verbal and written communication skills
Computer literate
Home office based in Italy or the UK – up to 50% travel

Clinical Study Manager Resume Examples & Samples

Ensure that all documentation in place for initial and subsequent
Displays innovative ideas and solutions
Highly proficient in negotiation skills
Highly effective in influencing others

Clinical Study Manager Resume Examples & Samples

Clinical research experience in all phases of study life cycle, including start up, interim and close out
Valid Passport
Excellent interpersonal skills and problem solving ability
Able to effectively prioritize workload
LI-JP1

Clinical Study Manager Resume Examples & Samples

Support protocol development, identifying and proposing solutions to potential operational challenges of the trial, providing and managing input to protocol
Maintain strong knowledge of the protocol to be able to answer standard operational questions from monitors, sites, and local internal personnel
Assist in development of local trial execution plan and timeline commitments
Oversee local vendor selection and performance as needed: track for any potentially significant quality/compliance issue and escalate as required
Manage contracts with external parties (e.g., care networks such as CROI/HBT and GP surgeries)
Hold and coordinate investigator meetings as per identified need
Develop and maintain relationships with key Medical Experts
Ensure that study start-up activities and any amendments are conducted and completed on time, including preparation of IRB/EC submission packages, working with regulatory affairs for Health Authorities submissions
Monitor status of site budget and contract negotiations as well as the collection and review of essential documents
Coordinate and manage site selection process in collaboration with line units
Drive study site communication and engagement; ensure sites are prepared for site initiation visits and documents for study launch are available
Ensure all documentation in place for initial and subsequent drug release in collaboration with local QA/Supply Chain
Provide training as needed for monitors and any other activities that support site readiness to recruit; ensure documentation of training is archived
Ensure all operational aspects are on schedule to achieve timelines and quality according to Novartis standards and local and international regulations
Consistently review all monitoring visit reports for the assigned trials to identify trends; appropriately escalate issues in a timely manner and ensure resolution
Conduct monitoring visits as required for select smaller local trials
Lead and chair local study team meetings
Track trial budget with appropriate trial budget responsible in the CPO
Keep oversight of country level data management activities, including timely resolution of data entry issues, screen failure reasons, discontinuation rates, patient profiles, and proactively identify data entry issues to mitigate queries
Keep trial reporting systems (e.g., ClinAdmin, TMF, CREDI) up to date
Ensure posting of assigned local studies to clinical trials.gov, including final publication of results

Clinical Study Manager Resume Examples & Samples

Recognizes potential challenges within the protocol and operational aspects of the trial and escalates to their manager, as appropriate. Maintains a strong knowledge of the protocol to be able to answer standard questions from monitors, sites, and local internal personnel
Supports the feasibility process and recommends US patient commitment. Ensures two-way feedback on feasibility between global team and US
Assists in the develop of the local trial execution plan and timeline commitments for the US
Coordinates and manages the site selection process in collaboration with the necessary line units
Drive the conduct and completion of study start-up activities and any amendments, including the preparation of IRB/EC submission package. Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents. Ensure sites are prepared for FPFV by monitoring the status of or initiating clinical trial supply delivery, provide training as needed for monitors and site personnel, and any other activities that support site readiness to recruit. Ensure documentation of training is archived appropriately
Conduct local investigator meetings as needed and/or participate in global investigator meetings as needed
Responsible for tracking the enrolment status of all sites for the trial in US. Assist in setting up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
Lead and chair local study team meetings, attend and participate in global clinical trial team meetings
Works with Program Finance Manager to track trial
Accountable for coordinating data management activities through the local trial team. Communicates with monitors and Investigator sites to ensure timely resolution of data issues. Review country level data including lab values, time to date entry at sites, screen failure reasons, discontinuations rates, patient profiles, and proactively identify data entry issues to mitigate queries
Responsible to keep reporting systems up to date (e.g. Impact/ClinAdmin, TMF, CREDI) throughout the lifecycle of the trial
Ensure that all trial close–out activities are performed, in close cooperation with field monitors and clinical trial head
Facilitate internal audits and HA inspections as required. Assist in monitor implementation of corrective actions following audits and inspections in relationship with Development Quality Responsible
Expected to manage less complex trials as defined by the US organization

Clinical Study Manager Resume Examples & Samples

Demonstrable experience in clinical research with proven proficiency in trial execution and drug development
Excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues
Expert knowledge of international standards (GCP/ICH),international (FDA, EMEA),local regulations and Novartis standards
Proven ability to manage teams and complex communication locally and in the global organisation
Knowledgeable in a specific disease area with established contacts in the medical community

Clinical Study Manager Resume Examples & Samples

Lead and chair local/cluster study team meetings, attend and participate in global clinical trial team meetings
Maintain a strong knowledge of the protocol to be able to answer standard operational questions from monitors, sites, local internal personnel
Conduct trial feasibility assessments according to local procedures. In liaison with the global clinical team, ensure development of local trial execution plan and timeline commitments for a country/cluster
Ensure solid recruitment strategies (incl. contingency plans) are developed and adhered to
Coordinate and manage the site selection process in collaboration with the necessary line units
Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required
According to local procedures, ensure proper development, negotiation and follow-up of trial budget in close collaboration with the Contract and Finance manager
Ensure sites are prepared for Ready to Initiate Site (checkpoint) by monitoring the status of clinical trial supply delivery
Drive the conduct of the trial, track and oversee progress and status. MVR review and Co-monitoring as agreed locally
Facilitate internal audits and HA inspections as required

Clinical Study Manager Resume Examples & Samples

Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data
Lead feasibility assessment and selection of countries and sites for study conduct
Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members
Provide oversight and direction to study team members for study deliverables; may provide direction to Associate Clinical Study Managers and Clinical Trial Associates for assigned studies
BA/BS degree with at least five years multi-country clinical trial experience or advanced degree
Fluent in English. Moderate (25%) travel required

Clinical Study Manager Resume Examples & Samples

Maintain a strong knowledge of the protocol to be able to answer standard operational questions from monitors, sites, local internal personnel etc
Recognize potential challenges within the protocol and decide on appropriate action/escalate to manager as appropriate
Conduct trial feasibility assessments according to local procedures
Ensure effective two-way feedback on feasibility between global team and country
In liaison with the global clinical team, ensure development of local trial execution plan and timeline commitments for a country/cluster
Ensure solid recruitment strategies (incl contingency plans) are developed and adhered to
Oversee local vendor selection and performance as needed
Ensure conduct of local investigator meetings as needed
According to local procedures, ensure proper development and follow-up of trial budget in close collaboration with the ICRO Nordic Finance Coordinator
Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents
Ensure sites are prepared for Ready to Initiate Site (checkpoint) by monitoring the status of clinical trial supply delivery,
Ensure that all documentation in place for initial and subsequent drug release in collaboration with the local Qualified Person
Provide training as needed for monitors and any other activities that support site readiness to recruit
Drive the conduct of the trial, track and oversee progress and status
Oversee local clinical team activities to achieve trial timelines and quality execution according to Novartis standards and local and international regulations
MVR review and Co-monitoring as agreed locally
Appropriately escalate issues in a timely manner and ensures resolution
Communicate with field monitors on a regular bas
Degree in scientific of healthcare discipline
Fluent in Danish and English, written and spoken
Minimum 5 years’ strong experience in clinical research, in a monitor role or a role overseeing clinical trials
Strong Interpersonal skills, Project Management and leadership skills
Ability to work under pressure and in a matrix environment
Highly proficient in negotiation skills and highly effective in influencing others
Thought leader in job role

Clinical Study Manager, Based Resume Examples & Samples

Likely to already have at least 3 years post graduate work experience within clinical affairs, pharma or medical device industry. Ideally with specific Orthopaedic product knowledge although more important to understand clinical study methodology – through having worked perhaps as a clinical research associate / senior CRA
Familiar with according guidelines and standards
Ideally experience of working with health care economists teams or at least a good understanding of the link between the two areas
Will have experience of working as part of a team, not just a single contributor
Will be experienced in multi-cultural international environment either at work or through other interests or activities
Will have had experience (at least 12m) of working with medical teams and Key Opinion leaders and be confident and articulate in their presence
Will have either developed alone or can provide evidence of their ability to define and manage a budget for a clinical study

Clinical Study Manager Resume Examples & Samples

Leading development of study designs, synopsis and protocol development (including drafting, revising, distributing, filing and archiving), executing the assigned studies, interpreting and summarizing the clinical study results, drafting and/or reviewing clinical documentation and reports. Manage CRO study teams for seamless execution of clinical studies
Authoring or reviewing other clinical study documents such as Informed Consent Forms, Clinical Study Reports, etc.; reviewing relevant documents from CROs or other vendors
Presenting study design and results both internally and externally. Obtaining comments/feedbacks/agreement within the Clinical team as well as broader teams in Regulatory Affairs Department
Following applicable clinical research regulatory requirements (Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) Guidelines)
Applying in-depth knowledge of principles of clinical research towards designing clinical studies in support of regulatory submissions. Anticipating technical or business issues and developing appropriate strategies
Developing and executing clinical studies to achieve objectives as a cross-functional team leader, leading collaboratively within framework of general goals, concepts and policies
Strategically allocating resources to solve problems across Altria's companies within budgetary guidelines
Interacting with senior management and external resources on business and technical issues. Independently developing and delivering presentations within the enterprise to other health scientists as well as senior management. Interacting within and across departments e.g. regulatory science, product development, program leaders for various regulatory submissions while participating in cross-functional projects
Ph.D. in clinical pharmacology or other health science related topics, training in medicine (MD or equivalent) from US or other qualified non-US universities preferred
5+ years of experience in clinical trials in the medical device, pharmaceutical, or tobacco industry
Overall flexibility and willingness to learn the tobacco industry and the growth of regulations relating to clinical research
Scientific background in biological sciences; understanding of tobacco-related biomarkers a plus
Demonstrated leadership and influence without managing authority is a strong plus
Strong interpersonal skills with the ability to build and enhance relationships with CRO study teams
Strong knowledge of FDA regulations, ICH guidelines, GCP practices
Working knowledge of various tools used in clinical trials including electronic data capture, electronic clinical outcomes etc
Understanding of regulatory document creation and review
May require traveling 20-25% of time

Clinical Study Manager Resume Examples & Samples

Broad view of the departmental goals and sees the “big picture” scientifically and strategically
Regularly interacts with Clinical Affairs and company leadership on matters concerning clinical development status
Devises efficient, effective clinical trial execution strategies; guides planning and execution of clinical studies, including management of study budgets, timelines, and external vendor(s) management
Proficient in clinical trial timeline and budget forecasting, using objective measures and tools to plan and communicate key clinical trial metrics
Exceptional planning, communication, and creative problem solving skills, ensuring trial delivery for one or more clinical trials
Leads by example and mentors other Clinical Operations team members, including employee development through company goal setting, performance management processes
Ensures compliance of clinical trials with federal and applicable regulatory agency requirements
Assists in the development and implementation of policies and standard operating procedures (SOPs) to be used in Clinical Operations
Integrates best practices as appropriate
Represents Ironwood in external interactions
BS/MS in a science or a health-related field
4 - 6 years of related work experience, with at least 2 years in a study management role
Biopharmaceutical (Sponsor) organization experience is a must. CRO experience is also desirable
Demonstrated effectiveness in resolving study management issues
Experience managing and training regional or consulting CRAs within project teams is required; direct line management is not required
In-depth knowledge of the CRO selection and contracting processes
Superb communication skills; effective in objective data interpretation and communication as well as expression of abstract ideas to all levels of the organization
Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance

Clinical Study Manager Oncology Resume Examples & Samples

Must have a Medical, Scientific or similar Bachelor Degree
Must have between 5 and 7 years of experience in Clinical Re-search as measured by proven proficiency in leadership, trial execution and drug development
Must have a strong understanding of general medical and clinical research practice in the Country as well as established contacts within the medical community
Must have commercial proficiency with business and market knowledge
Must have proven experience and ability to managing local, regional and global teams and know how to develop them
Must have experience managing financial activities (such as budget, reports, approve expenses, etc…)
Must understand the international aspects of drug development process, including ex-pert knowledge of International Standards (GCP/ICH), Health Authorities (FDA, EMEA), local/ National Health Authorities regulations and Novartis standards
Preferably working before in Pharma companies
Has extensive networking

Senior Clinical Study Manager Resume Examples & Samples

Provides oversight and project management of clinical studies at Avanir, including planning, execution, and completion of clinical trials according all applicable regulations and guidance, ICH/GCP, and Avanir SOPs
Manage and facilitate development/review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Study Plans, Case Report Forms, Source Documents, Monitoring Plans, Data Management Plan, Project Management Plan, etc.)
Provide clinical operations oversight in the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites
Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required
Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast
Provide timely communication of any variances in budget forecast to the Clinical Department Head
5+ years demonstrated work experience of successfully managing clinical trials within the pharmaceutical industry, including CRO and contract vendor management, preferably in the CNS therapeutic area
Experience in clinical site monitoring
Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans, etc
Ability to supervise, direct and lead team members as well as interact with other internal staff
Strong planning and organizational skills with ability to multi-task and plan activities as they relate to the management of clinical trials, ability to problem-solve
Possess advanced computer skills (Microsoft applications, spreadsheets, etc.)
Financial management skills as applicable to oversee project expenditures
Ability to travel up to 50% travel including ground and air required

Clinical Study Manager Resume Examples & Samples

Responsible for timely set up, organization, content and quality of the relevant sections of the Trial Master File
Responsible for the implementation and training of standardized clinical monitoring processes according to corporate standard policies
Responsible for the timely archiving of documents and study materials for the clinical department
Monitors clinical activity timelines and metrics
Monitors /co-monitors clinical trials as needed to assess performance and/or ensure contractual obligations are met
LI-NA1
Bachelor's degree or licensed certified health care training or equivalent combination of education and experience
Significant clinical research experience (comparable to 3+ years) in all phases of study life cycle, including start up, interim, close out and CRA field monitoring

Senior Clinical Study Manager Resume Examples & Samples

As a guide, a minimum 6+ years’ relevant clinical research (or related) experience within the pharmaceutical industry
Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
Postgraduate qualifications
Experience in scientific/medical research
Specialist knowledge (e.g. immunology, coagulation disorders, pulmonology, virology, oncology, and cardiology)

Clinical Study Manager Resume Examples & Samples

Ensure progress reporting (resources, budget, timelines)
Assess operational feasibility of study
Select countries, sites, investigators
Develop study document, set-up and maintain study files
Arrange EC/regulatory submissions, study registration
Set up and manage study budget, contracts and payments
Supervise third parties
Perform and supervise site initiation, site management, site monitoring, site close out
Safety reporting
Safeguard quality of study and escalate compliance issues
Align activities with team members (e.g. data management, supply management)
Experience with Ethical Committee submission
Knowledge of ICH-GCP guidelines
Experience with site preparation, management and monitoring
Experience with working with eCRF
Excellent communication skills, also in English
Flexible to perform site visits mainly through Europe

Clinical Study Manager Resume Examples & Samples

Supporting the Operations Science Lead in study execution, tracking and management of study delivery
Ability to work within cross functional study-teams, including CRO teams where applicable
Ensures set up and maintenance of all systems in order to plan and implement the study and track progress
Ensures adherence to GCP and all applicable local and international regulations
Supports the development, review, finalisation and delivery of high quality key clinical study documents in order to meet study timelines
Ensures accurate maintenance and archiving of study records in electronic Trial Master File (eTMF)
Track study progress against milestones at each stage of the study and ensure actions taken to deliver recruitment to target and plan
Oversee and where applicable take on the co-ordination of investigator and monitors’ meetings, when required

Clinical Study Manager Resume Examples & Samples

Assess study feasibility, collaborating with Clinical Strategy Lead through the study design process and collaborate with project team to develop clinical study protocols and associated documents
Train investigators, research coordinators, CROs, central laboratories and other study vendors on study related procedures
Plan, manage and report all aspects of global clinical studies through oversight of cross-functional study activities
Create and report clinical study updates to management on a regular basis; report on performance to plan
Coordinate and oversee clinical studies to support regulatory submissions (IDE, PMA, 510(k) and Post Market Surveillance); assist in preparation of clinical study reports, regulatory documents and submissions
Independently liaise with ASD product teams and in country sales and marketing personnel to ensure effective study alignment with product strategy throughout the design, implementation and lifetime of the clinical study
Monitor and/or oversee monitoring by CRAs, to ensure compliance with study protocols, regulatory requirements and Smith & Nephew procedures
Follow current SOPs and conduct peer training on processes/procedures

Principal Clinical Study Manager Resume Examples & Samples

Conduct and oversight of clinical / human subject research programmes, including review and input into clinical trial protocols and study reports to ensure that they are robust from an operational standpoint
Subject matter expertise on implementing good clinical practice and evolving trends in clinical research operations: leading GSK CH R&D improvement and change implementation
Develop and deploy the CH R&D process, SOPs and other written standards for the conduct of human subject research globally
Documented oversight of third party providers with appropriate risk management to ensure high quality deliverables with compliance to GCP/ICH and other local regulations

Clinical Study Manager Resume Examples & Samples

Coordinating the activities of interdisciplinary Gore team members and Contract Research Organizations (CROs) in the planning, executing and closing of clinical studies
Developing Study Reports and providing clinical portions for Regulatory submissions
Acting as a company liaison to work with clinical sites, CROs, and other vendors
Budget forecasting
Payment approvals
Participating in Clinical Affairs Process Improvement initiatives
Bachelor’s degree in science/health related field. Experience in clinical research; medical devices industry preferred
Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint, Lotus Notes)
Fluent written and oral English
Experience working on cross-functional and cross-regional teams

Global Clinical Study Manager Resume Examples & Samples

Responsible for the delivery and quality of clinical studies from protocol concept to execution to the final study report
Maintain routing and efficient communication with global team for ongoing studies
Participate in quality assurance activities and coordinating resolution of audit findings
Ensure set up and maintenance of all systems to plan and implement the study and track progress
Minimum of 3-5 years of clinical research experience with the broad understanding of the pharmaceutical industry and the clinical development process
Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical research
In depth knowledge of study management and data management
Excellent leadership and communication skills (both verbal and writing)
“Think outside of the box” mentality

Senior Global Clinical Study Manager Resume Examples & Samples

Ensure adherence to Good Clinical Practice (GLP) and all applicable local and international regulations
Work with medical monitors and medical writers to coordinate and contribute to the protocol development that meets scientific objectives and can be implemented in the clinic settings
Ensure audit-ready conditions of clinical trial documentations including TMP
Responsible for the identification, evaluation, and selection of CROs, clinical sites and investigators, with appropriate qualifications, patient populations, and recruitment strategies to meet goals in a timely and cost-effective manner
Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
Demonstrate effective oversight of outsourced activities
Strong organizational skills with problem solving and team building skills
Energetic and self-motivated

Clinical Study Manager Resume Examples & Samples

At minimum, bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
A minimum of 4+ years’ relevant clinical research (or related) experience within the pharmaceutical industry. Experience in supporting the execution of global clinical trials. Understanding of budget forecasting and management. Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
Ability to work independently with some oversight in the support and/or management of clinical trial execution
Demonstrated ability to lead teams and work in a fast-paced team environment. Experienced in working within a Matrix Environment. Excellent interpersonal and decision making skills
Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills. Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
Domestic and international travel required. Amount dependent upon project needs

Clinical Study Manager Resume Examples & Samples

3 years of experience in pharmaceutical industry or health related field
Associates Degree or equivalent experience
Proficiency in multiple software applications and ability to provide expertise and lead user capability
Knowledge of the clinical development process and FDA/ICH/GCP regulations
Experience with study related legal agreements
Experience working directly on Clinical Trials Operations
Experience working on multiple clinical studies, including complex projects assignments in a matrix environment
5 years of experience in pharmaceutical industry or health related field
Bachelors Degree or equivalent experience
Experience of issue identification and provision of practical and workable solutions
Experience independently managing projects and assignment, including assuming full accountability for delivery results
Provides operational support at the country and/or above country global level for ISS’s and Collaborative studies and interacts with and supports internal matrix partners and external partners (e.g., GSK staff and vendors)
Provides detailed understanding of, and expertise with, source and tracking systems used by VH Operations
Responsible for the accuracy and integrity of data within source and/or tracking systems through independent and proactive gathering, entry and interpretation of information
Responsible for representing VH on appropriate working groups and proactively communicating with the Operations Team any updates and/or changes to the source systems software
Responsible for recognizing, communicating and resolving source system issues, maintain ISS intranet webpage working either independently or with the appropriate individuals
Coordinate and manage the operational activities related to an internal committees, with responsibilities including, but not limited to, meeting planning, agenda development and meeting minutes
Identification, development and enhancement of study specific processes and procedures for operationalizing studies, while adhering to standardization and sharing of best practices
Review and track study invoices and accruals, including resolution of investigator grant payments, invoice accuracy, comparison to contract and outstanding payments and assist with Fair Market Value Assessments
Work with matrix partners to develop accurate milestone forecasts
Compile ISS accrual and payment data to provide detailed quarterly finance updates to ViiV Finance
Act as SAP on studies as appropriate
Assist with the maintenance and archiving of electronic study files for supported studies

Senior Clinical Study Manager Resume Examples & Samples

Determines project objectives, strategy, scope and schedule to meet business needs
Develops the project Plan in consultation with the cross-functional project team, project stakeholders and the clinical team
Presents project plans, provides ongoing updates, and presents project results to SJM senior clinical management
Assists in the management and execution of the clinical project
Ensures all SJM staff are trained on the requirements of the clinical project and project plan
Responsible for ensuring the clinical project is “audit ready” at all times (project team training records, central files, system validation, etc.)
If applicable, ensures adequate monitoring is conducted on all clinical project
Conducts clinical visits as needed to support clinical project
Enlists support and specifies tasks for various team members to assure meeting objectives are completed on schedule
Provides oversight of clinical projects to ensure safety concerns and/or adverse events or trends in Field Events Reporting are identified and appropriate responses are developed and executed
Provides clinical input and support for planning post-project activities and product market launch
If applicable, authors/co-authors project results in medical literature plans and/or presents at scientific investigation meetings
Monitors project reports for accuracy and trending
Provides input to project budgets and project plans
Provide clinical scientific support to project teams
Evaluates clinical data in preparation of study summary reports for presentations, publications, and submissions
Develops and implements corrective actions as needed to address any noncompliance issues
Performs LA Reviews of marketing materials related to clinical project
Communicates with and provides updates to specific core teams
Oversees activities delegated by Sr. Clinical Research Manager or Sr. Director, Clinical
Provides input and support for planning post-trial clinical activities and product market launch
Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Bachelor’s degree (technical or non-technical). Technical degree defined as engineering, biological sciences or related medical/scientific field
Minimum 3-5 years’ experience directly supporting clinical research or similar experience in a medical/scientific area
1-3 years’ experience managing projects, strong project management skills are needed
Experience working with clinical professionals within a team
Experience working in a cross-functional product development setting
Master’s degree will substitute for 1 year of experience
A Ph.D. or MD will substitute for 2 years of experience
Advanced written and oral communications skills
Able to manage multiple tasks
Proficient knowledge of medical terminology
Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA)
Advanced knowledge of clinical and outcomes research study design
Demonstrated ability to work effectively on cross-functional teams

Clinical Study Manager Resume Examples & Samples

Must have a Degree in Scientific or Healthcare Discipline
A Master Degree will be a plus
Must have minimum 5 years of experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
Must have experience in the following Therapeutic Areas – Oncology, Hematology, Respiratory, Cardiovascular, Dermatology or similar
Must have experience being capable of leading in a matrix environment and people management, without direct reports
Must have experience understanding of all aspects of Clinical Drug Development with particular emphasis on monitoring and study execution
Must understands the Project Management Methodology, identify roles, structures and responsibilities in the Medical Department, timelines, KPI´s, SOPs, quality
Experience with Project Management ideally in Clinical Trials is preferable
Must have excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues
Must have experience in Internal and External Audits
Must have experience understanding International aspects of Drug Development Processes, including ex-pert knowledge of International Standards (GCP/ICH), Health Authorities (FDA, EMEA), local/ National Health Authorities regulations and Novartis standards
Has excellent abilities to communicate, influence, persuade and negotiate with different teams and stakeholders
Has high ethic and integrity skills
Has the ability to solve problems and complex issues
Has people management and team player skills
Has the ability to identify training and development issues
Advanced English skills (written, reading and speaking)

Lead Clinical Study Manager Resume Examples & Samples

Execution of clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and SOPs, and supporting clinical strategy defined in Clinical Study Plan (CSP) in support of the Integrated Global Development Plan (IGDP)
Lead cross functional Study Execution Team, including functions, Strategic Partners and other vendors to ensure study goals are met, on time and within budget. Includes leading and organizing cross functional study team meetings
Responsible for providing study level updates, including timelines & budget, to the cross-functional Clinical Program Team (CPT) ensuring that any study issues, with proposed solutions, are escalated to the CPT, as appropriate
Management of the study budget, including Task Orders, Change Orders, invoice approval and financial reconciliation process
The assigned clinical study/studies will be global or multinational, large, complex, high risk and/or of business importance to, requiring multi-functional leadership experience and skills to achieve study goals. Principal Study Manger may also take on program level responsibilities, under the direction of Clinical Program Manager
Manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and SOPs, and supporting clinical strategy defined in Clinical Study Plan (CSP)
Ensure appropriate regional input for global or multinational studies prior to decision making. Responsible for communication of study information to Clinical Operations regions
Contributes to protocol synopsis development and to Clinical Study Plan development, including Clinical Operations feasibility assessments
Leads the cross functional protocol development process, including responsibility for any protocol amendments or administrative changes
Management of Strategic Partners, including setting expectations, training, CRO Oversight process, Task Orders, Change Orders, invoice approval and financial reconciliation process for assigned study. Responsible as first point of contact for Issue Management process for assigned study. (Range: $750,000 (e.g. less complex Phase 1) to $250 million(large complex outcomes studies))
Leads the evaluation and selection of required vendors, including contract and budget negotiation, invoice approval and financial reconciliation process. Responsible for day-to-day management of vendors working on assigned study, including setting expectations, training, managing timelines and deliverables, and issue management. Provides Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, writing the Clinical Study Report
Escalates medical issues to appropriate medical personnel
Provides regular budget updates to Clinical Program Manager, or Finance when required
In collaboration with Study Execution Team (functions, Strategic Partners, and vendors), identify risks to study and develop risk mitigation plans, including communication and collaboration with Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning
May be asked to participate in issue management and risk mitigation for studies assigned to other Study Managers
Able to assist in role of Clinical Program Manager and may represent Clinical Program Manager, when necessary
Leads or provides expert input for Clinical Operations or cross functional initiatives
Good understanding of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required
Solid teamwork, organizational, interpersonal, and problem solving skills; exercises good judgment with respect to confidential information and strategies
Minimum of 7 years experience in clinical research in the pharmaceutical industry or clinical research organization
CRA experience preferred
Protocol writing/study design experience required
Experience must including Phase 2 and 3 studies and global / international studies
Demonstrated excellence in study management, including innovative operations approaches to achieving program goals

Senior Clinical Study Manager Resume Examples & Samples

Provide input to protocol, and operational aspects of the trial. Maintain a strong knowledge of the protocol to be able to answer questions from monitors, sites, and local internal personnel
Independently leads trial feasibility process and CPO patient commitments: ensures two-way feedback on feasibility between global team and US
Independently develops strategic local trial execution plan (e.g. recruitment retention, contingency plans) and timeline commitments (TAMS) for the US
Drive the conduct and completion of study start-up activities and any amendments, including the preparation of IRB/EC submission package. Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents. Ensure sites are prepared for FPFV by monitoring the status of or initiating clinical trial supply delivery, provide training as needed for monitors and site personnel, and any other activities that support site readiness to recruit. Ensure documentation of training is archived appropriately. Conduct local investigator meetings as needed and/or participate in global investigator meetings as needed
Responsible for the initial and subsequent drug release in collaboration with the local Qualified Person
Responsible for tracking the enrolment status of all sites for the trial in the US and setting up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
Drive the conduct of the trial, track and oversee progress and status. Ensure all operational aspects are on schedule. Oversee local clinical team activities to achieve trial timelines and quality execution according to Novartis standards and local and international regulations
Consistently reviews monitoring visit reports to identify trends/issues. Appropriately escalates issues in a timely manner and ensures resolution. Communicates with field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics
Works with Program Finance Manager to track trial budget
Oversee local vendor selection and performance. Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required
Facilitate internal audits and HA inspections as required. Assist in Monitoring implementation of corrective actions following audits and inspections in relationship with Development Quality Responsible
Mentor/coach other Local Study Mangers and CTCs
Expected to manage more complex trials as defined by the US organization

Clinical Study Manager Resume Examples & Samples

Be passionate about managing clinical study data for state-of-the art implantable medical devices
Developing study reports and providing clinical reports for regulatory submissions
Bachelor’s degree in science and/or health related field
Minimum 3 years’ experience in clinical trials
Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint, CTMS)
Experience working on cross-functional, remote teams
Travel as necessary to achieve business and project objectives (approximately 30%)
Experience in clinical/scientific research, nursing, or medical devices/pharmaceutical industry
Device trial experience

Clinical Study Manager Resume Examples & Samples

Provide clinical trial management expertise, leadership and guidance to in-house and out-sourced study team members, ensuring process consistency and knowledge sharing
Analyze and report safety issues, patient care issues and study design and/or study conduct issues
Prepare detailed study timelines and contribute to development of clinical site budgets for assigned clinical studies
Develop action plans to address issues with investigators, clinical sites, or Clinical Research Associates (CRAs) and direct study monitoring priorities
Maintain regular contact with relevant internal departments such as Manufacturing, Operations, Regulatory, Project Management, Quality Assurance, and Research
Assist in the preparation of investigator brochures, clinical study reports, clinical sections of INDs, Appendix M, IND annual reports, etc
Collaborate with Quality Affairs staff to develop a quality plan, including audit readiness assessments, for assigned clinical trials
Contribute to departmental Standard Operating Procedures (SOPs), procedures, and template forms
May perform co-monitoring, as necessary
Eight or more years’ experience in clinical trial operations with at least 3 years’ experience in the management of complex oncology clinical trials. Previous hematology trial experience and experience with FDA inspections is desirable
Demonstrated proficiency in the implementation, monitoring and management of clinical trials
Clear and concise verbal and written communication skills
Strong organizational and motivational skills, with an exceptional attention to detail
Proven experience successfully juggling multiple teams, external sites and projects in a dynamic environment
Proficiency with MS office suite, including MS Project, and SharePoint
Availability to work onsite in Seattle office
Ability to travel approximately 30-40%, including some weekend travel for business and to attend meetings