A Clinical Trial Manager is a professional who oversees and manages the entire process of conducting clinical trials. Clinical trials are research studies that test the safety and effectiveness of medical treatments, drugs, or devices on human participants. The role of a Clinical Trial Manager is crucial in ensuring that these trials are conducted efficiently, ethically, and in accordance with regulatory guidelines. In this blog post, we describe the primary responsibilities and the most in-demand hard and soft skills for Clinical Trial Managers.

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Main Responsibilities of a Clinical Trial Manager

The following list describes the typical responsibilities of a Clinical Trial Manager:

Adhere to

• Adhere to scope and routinely reviews Clinical Trial.

• Adhere to scope to ensure assigned clinical staff routinely.

Adopt

Adopt corporate initiatives and changes and serve as a change advocate when necessary.

Align

Align study start-up, enrollment, study conduct and close-out activities with project goals.

Analyze

Analyze and triage problems, prioritize accordingly, and propose solutions.

Apply

Apply project management best practices to programs.

Assess

Assess site processes, perform review of all Source Documents and medical.

Assist with

• Assist CPL by tracking compliance to all study level plans and escalating any variances.

• Assist CPL with Interactions with CRO and site staff to adhere to study budgets.

• Assist in designing, planning and implementation of clinical trials.

• Assist in determining the activities to support a project's priorities within a functional area.

• Assist with CRA and third-party vendor training on protocols and practices.

• Assist with cross functional training on protocols and practices.

• Assist with preparation for and execution of site and regulatory authority or QA audits.

• Assist with processing vendor invoices, investigator payments, and expense reports.

Attend

• Attend co-monitoring visits as required.

• Attend site visits (PSSVs, SIVs, motivational) as needed.

Author

Author clinical trial protocols in collaboration with the Medical Expert or Clinical Scientist.

Chair

Chair internal clinical trial teams with representation from relevant functional areas.

Coach

Coach, develop and train junior CRAs / CTAs on increasing responsibilities and core competencies.

Collaborate

Collaborate with data management teams to ensure accurate and timely data collection.

Co-manage

Co-manage vendors with CRO and ensure data quality.

Communicate

• Communicate effectively with internal and external stakeholders, including sponsors and regulatory authorities.

• Communicate to leadership internally on progress and issues.

Compile

Compile documentation for qualification of clinical sites.

Conduct

• Conduct oversight monitoring activities as needed.

• Conduct protocol and site feasibility assessments.

• Conduct quality control visits with CRAs.

• Conduct regular meetings with investigators and trial teams to provide updates and address any issues.

• Conduct trial feasibility assessments and site selection visits.

Contribute to

• Contribute to development of RFPs and participates in selection of CROs / vendors.

• Contribute to the development of clinical trial policies and guidelines.

• Contribute to the development of the Clinical Monitoring Plan.

• Contribute to the development of the study budget.

• Contribute to wider organizational goals and / or activities as assigned.

Coordinate

• Coordinate and drive identification, assessment and selection of relevant CROs and vendors.

• Coordinate and ensures country level study enrolment targets and timelines are met.

• Coordinate and lead CRA meetings.

• Coordinate and liaise with external vendors, such as contract research organizations (CROs) and central laboratories.

• Coordinate and manage all aspects of the trial, including budgeting, timelines, and resources.

• Coordinate and support audit and inspection activities.

• Coordinate / plan investigator meetings and / or site and CRA training.

• Coordinate review of data listings and preparation of interim / final Clinical Study Reports.

• Coordinate study team training in the investigator portal.

Create

Create and manage RFP and bid defense process for next wave studies.

Delegate

Delegate specific activities to Regional CTMs, as appropriate.

Deliver

Deliver the project / program according to the quality management plan.

Develop

• Develop and executes corrective.

• Develop and executes corrective action plans at study (global) level to address any issues.

• Develop and maintain study timelines, enrollment dashboards, and budgets.

• Develop and maintain trial documentation, including informed consent forms and case report forms.

• Develop and manage clinical trial budgets.

• Develop and manage trial timelines, budget and project milestones.

• Develop country level patient recruitment strategy & risk mitigation.

• Develop key study quality metrics and determine appropriate action in conjunction with study team.

• Develop presentations for clinical sites, team and investigator meetings.

• Develop proactive contingency plans to mitigate clinical risk.

• Develop recruitment plans, risk mitigations plan, monitor and implement contingencies as required.

• Develop study oversight plans for BlueRock and in partnership with a CRO.

• Develop the strategy for outsourcing of clinical trials.

• Develop trial protocols and study designs.

Document

Document escalations and actions.

Drive

• Drive and manage the clinical and site management aspects of assigned project.

• Drive CAPA review, implementation and completion.

Ensure

• Ensure alignment of clinical activities to budget, including.

• Ensure availability of clinical / non-clinical.

• Ensure clinical trials are executed according to external regulations and internal procedures.

• Ensure compliance with Good Clinical Practice (GCP) guidelines and relevant regulations.

• Ensure CRA compliance with the study parameters via review of monitoring visit reports.

• Ensure CRO, vendors and sites are aligned with deliverables and expectations.

• Ensure feedback and follow-up to CRO with any concerns.

• Ensure Inspection Readiness for Clinical Scope.

• Ensure inspection readiness of assigned trials within country.

• Ensure internal and external systems are updated in a timely manner (CTMS, clinicaltrials.gov).

• Ensure proper storage and handling of investigational products.

• Ensure that visit metrics are maintained as required.

• Ensure the effective selection, initiation and motivation of clinical study sites.

• Ensure these deliverables are.

• Ensure these learnings are shared with the business.

• Ensure timelines are met.

• Ensure trial adherence to ICH / GCP / local regulations.

• Ensure trial data integrity and confidentiality.

Escalate

• Escalate findings and action plans to appropriate parties.

• Escalate risk to timelines and budgets ad needed.

• Escalate study-related issues appropriately in a timely manner.

Establish

Establish vendor management plans and review quality metrics.

Evaluate

Evaluate trial outcomes and contribute to the interpretation of results.

Facilitate

• Facilitate and SMT for assigned projects as requested.

• Facilitate CRO / vendor selection process for assigned vendors.

• Facilitate the development and implementation of standard operating procedures (SOPs).

Generate

• Generate country specific Informed Consent Form(s).

• Generate necessary reports to update leadership on trial conduct and progress.

Guide

Guide internal reviews and evaluations.

Identify

• Identify, address, and communicate quality and compliance concerns.

• Identify and mitigate potential risks and challenges during the trial.

• Identify areas of concern and escalate to Clinical Operations Manager.

• Identify barriers to timely and successful trial execution and propose creative solutions.

• Identify changes in scope and support project leader in completion of the change control process.

• Identify potential risks and resolve issues with CROs.

• Identify study risks, develop and implement mitigation strategies.

Implement

Implement and maintain quality control measures throughout the trial.

Include

Include review of invoices for accuracy compared to vendor contract.

Interact with

• Interact with clinical research investigators and sites.

• Interact with Senior Management to report on progress of milestones.

• Interact with the client and other functional departments.

• Interact with the client and other functional departments related.

Lead

• Lead and manage clinical vendors with focus on deliverables.

• Lead cross-functional study team in support of study deliverables.

• Lead or participate in functional initiatives and / or activities as assigned.

• Lead problem solving and resolution efforts to include management of risk, contingencies and issues.

• Lead study team meetings locally.

• Lead the site feasibility and selection process.

Liaise with

Liaise with ethics committee regarding rights, safety and well-being of trial subjects.

Maintain

Maintain operational, financial and regulatory integrity and safety.

Manage

• Manage and maintain trial databases and electronic data capture systems.

• Manage and oversee contracted CROs and vendors.

• Manage cross functional timelines and maintain the study timelines.

• Manage staff and provides technical advice to team members.

• Manage the evaluation and selection of investigative sites.

• Manage the planning, execution, progress and completion of assigned clinical research projects.

• Manage the study level budget and track against budget with all parties.

• Manage trial budgets and expenses.

• Manage trial sites, including initiation, monitoring, and close-out visits.

• Manage vendors, including CROs.

Mentor

Mentor Senior Clinical Trial Associate.

Monitor

• Monitor and track clinical trial progress and provide status update to stakeholders.

• Monitor participant enrollment and eligibility criteria.

• Monitor site / CRA user access and track compliance during the study.

Negotiate

Negotiate and finalize site contracts and budgets.

Obtain

Obtain necessary approvals from regulatory bodies and ethics committees.

Oversee

• Oversee adverse event reporting and safety monitoring.

• Oversee data discrepancy management and training as needed.

• Oversee the recruitment and enrollment of study participants.

• Oversee timely issue resolution at sites.

Participate in

• Participate and respond to Quality Assurance and regulatory authority inspection audits.

• Participate and review SOPs for clinical operations and other functional areas as needed.

• Participate in bid defense preparations.

• Participate in Case Report Form design, user acceptance testing in partnership with data management.

• Participate in data management activities, where indicated to ensure highest data quality.

• Participate in departmental or interdepartmental strategic initiatives under limited supervision.

• Participate in identification, assessment and selection of relevant CROs and vendors.

• Participate in initiatives and / or special projects, as assigned.

• Participate in internal clinical trial team meeting.

• Participate in operation meetings with CRO, and cross-functional team members.

• Participate in other clinical operations initiatives as requested by client.

• Participate in the development and maintenance of, and adhere to departmental SOPs and guidelines.

• Participate in the development and review of clinical study reports.

• Participate in the development, review and implementation of departmental processes and SOPs.

• Participate in the selection and evaluation of trial sites and investigators.

Perform

• Perform and manage data review process on an ongoing basis.

• Perform co-monitoring visits with CRAs.

• Perform initial review of CRO and other third-party study vendor invoices.

• Perform monitoring oversight visits (onsite or remote).

• Perform other work-related duties as assigned or required.

• Perform review and QC central clinical files and trial master file.

• Perform review and QC of trial master file, ensuring overall inspection readiness.

Plan

• Plan and carry out professional development.

• Plan and drives patient recruitment and retention.

• Plan and guidelines, data plans and timelines for the project.

• Plan and lead regular clinical project.

• Plan and lead regular clinical study team.

• Plan and participate in Monitor and Investigator Meetings.

Prepare

• Prepare and conducts project-specific training for the CRAs.

• Prepare and submit trial progress reports to relevant stakeholders.

• Prepare for and participate in regulatory inspections.

• Prepare, maintain, and complete training on study-specific and (or) applicable sponsor SOPs.

• Prepare materials for Site Initiation Visits.

• Prepare updates for management.

Present

Present study status reports of operational execution activities to senior management.

Prompt

Prompt study team staff to provide timely and accurate reports of travel expenses.

Provide

• Provide drug supply assumptions to the clinical planning team.

• Provide input on the development of eCRF design.

• Provide input / reviews DSUR, PSUR and regulatory annual and periodical reports.

• Provide input to line managers of their project team members' performance relative to project tasks.

• Provide leadership and input into global subject / patient recruitment plans.

• Provide leadership, mentoring, and technical support to the Clinical.

• Provide mentoring / oversight of CRAs and Lead CRAs.

• Provide professional clinical research expertise to support the Business.

• Provide study-specific direction and mentoring to other staff as appropriate.

• Provide support to clinical trial managers within and / or across programs.

• Provide support to Health Authority inspection and pre-inspection activities.

• Provide training and support to trial staff on protocol implementation and compliance.

Read

Read, write and speak fluent English.

Record

Record and inventory visit reports received from monitoring staff.

Recruit

Recruit and train investigators, trial staff, and study coordinators.

Request

Request accruals, and perform contract and invoice review.

Research

Research certification desirable.

Resolve

Resolve conflicts and issues that arise during the trial.

Review

• Review and approve vendor invoices.

• Review and critique electronic CRFs for accuracy and completeness.

• Review and track key study metrics and progress reports.

• Review and track monitoring report issues and GCP compliance concerns, and monitor performance.

• Review draft protocols / protocol amendments and provide feedback on behalf of Clinical Operations.

• Review investigator contracts and site payments.

• Review monitoring reports and monitoring visit letters to assess trends and site performance.

• Review or approve of IMP release packages.

• Review protocol deviations and data listings.

• Review site visit reports.

• Review status and trends at the study.

• Review the content and quality of site monitoring.

Select

Select, coordinate and monitor the activities of CRO and associated vendors.

Stay updated with

Stay updated with current regulations and industry trends.

Summarize

Summarize findings and establish action plans to bring corrective actions.

Supervise

Supervise study sites and activities to ensure adherence to study protocols.

Support

• Support IRB / IEC and regulatory submissions, as needed.

• Support staff development.

• Support the business to develop and implement clinical research standards.

• Support the professional development and mentoring of Clinical Trial Manager Associates.

• Support the project leader in ensuring the financial success of the project.

Track

Track all decisions and items that develop from internal meetings.

Work with

• Work closely with investigative site personnel, CROs, and other study vendors.

• Work cross-functionally to ensure clinical program timelines and goals are met.

• Work with CROs and vendors to drive timelines and deliverables.

• Work with Project team to manage study timelines and budgets.

Most In-demand Hard Skills

The following list describes the most required technical skills of a Clinical Trial Manager:

1. Proficiency in clinical trial management software and electronic data capture systems.

2. Knowledge of regulatory guidelines and compliance requirements (e.g., ICH-GCP, FDA regulations).

3. Experience in clinical trial protocol development and study design.

4. Strong understanding of clinical trial methodologies and processes.

5. Familiarity with statistical analysis and data interpretation.

6. Project management skills, including budgeting, resource allocation, and timeline management.

7. Excellent organizational and multitasking abilities.

8. Competence in risk management and problem-solving.

9. Proficient in using Microsoft Office suite (Word, Excel, PowerPoint).

10. Understanding of medical terminology and scientific research principles.

11. Knowledge of safety reporting and adverse event management.

12. Ability to collaborate and communicate effectively with cross-functional teams.

13. Strong attention to detail and accuracy.

14. Familiarity with clinical trial documentation and record-keeping.

15. Understanding of quality control and quality assurance processes.

16. Experience in vendor management and contract negotiation.

17. Familiarity with electronic trial master file (eTMF) systems.

18. Proficiency in data management and analysis software.

19. Knowledge of pharmacovigilance and regulatory reporting.

20. Familiarity with clinical trial database systems and electronic data capture (EDC) platforms.

Most In-demand Soft Skills

The following list describes the most required soft skills of a Clinical Trial Manager:

1. Excellent communication skills, both written and verbal.

2. Strong leadership and team management abilities.

3. Effective problem-solving and decision-making skills.

4. Adaptability and flexibility in a dynamic and fast-paced environment.

5. Strong interpersonal skills and the ability to build relationships with stakeholders.

6. Attention to detail and a high level of accuracy in work.

7. Time management and organizational skills to meet deadlines.

8. Collaboration and teamwork to foster a productive and positive work environment.

9. Ethical and professional conduct, including maintaining confidentiality and integrity.

10. Critical thinking and analytical skills for evaluating complex information.

Conclusion

Clinical Trial Managers play a critical role in ensuring the success of clinical trials. Their responsibilities range from study design and protocol development to site management, data collection, and reporting. In addition to technical expertise, they need a combination of hard and soft skills to effectively manage trials and collaborate with various stakeholders.