JOB SUMMARY

The Clinical Trial Manager (CTM) is accountable for the end-to-end delivery of all Clinical Operations activities and deliverables for assigned global or regional clinical trials, from pre-award support and study start-up through enrollment, treatment, close-out, and study completion.

The CTM provides cross-functional leadership for global site management, patient enrollment, monitoring strategy and execution, Clinical Monitoring Plan development, implementation of Risk-Based Monitoring principles, CRA training, and site performance. The CTM also ensures audit-ready data delivery across international matrix environments.

Additionally, the CTM may assume direct line-management responsibilities for CRAs, providing ongoing mentorship, performance evaluations, and professional development support.

The CTM proactively provides the Project Manager with accurate Clinical Operations information, forecasts, risks, mitigation strategies, and recommendations to support effective project-level decision-making.

The CTM ensures that clinical activities comply with Good Clinical Practice (GCP), standard operating procedures, applicable regulations, and study protocols.

RESPONSIBILITIES

• Develop the clinical operational delivery strategy in alignment with the protocol, Sponsor objectives, contracted scope, timelines, and budget
• Lead Clinical Operations activities from study planning through study completion ensuring consistent implementation of the clinical strategy across countries and regions
• Maintain comprehensive protocol and amendment training curricula for all assigned CRAs. Ensure immediate retraining cascades following protocol amendments,
• Translate protocol requirements into an executable clinical delivery plan and develop core study documentation (CRFs, monitoring plans, reference manuals, tracking logs).
• Serve as primary clinical contact and resource for CRAs, sites and customer
• Maintain clear accountability for clinical deliverables while collaborating with the Project Manager and other functional leads on monitoring strategy and monitoring schedule Ensure at study/program level site source documents, CRFs and/or EDC for accuracy, completeness, and compliance with GCP, ICH guidelines, and protocol requirements.
• Identify potential Clinical Operations scope changes and communicate them promptly to the PM assisting in evaluating the impact of changes in scope, timelines, site numbers, countries, monitoring requirements, or recruitment assumptions.
• Proactively identify clinical risks and underperforming or high-risk sites early and implement corrective or recovery plans
• Participate in Sponsor meetings and present Clinical Operations status, risks, trends, and recommendations.
• Contribute to site identification and selection and global recruitment strategies with relevant functions.
• Ensure sites are operationally ready before initiation and enrolment and monitor site performance through appropriate metrics and indicators.
• Identifies areas in which resources or progress are not consistent with the project plan and in the formulation of corrective action plan;
• Communicate up-to-date information regarding study progress to all relevant parties
• Attendance at Investigator Meetings as needed, attendance at other meetings with sponsors or their agents as needed
• Lead and/or line manage CRAs, CRAs, Site Managers, and regional/country Clinical Operations resources
• Accountable for clinical delivery of patient enrolment against the agreed study plan.
• Develop the operational enrolment strategy with Feasibility, the Sponsor, sites, and relevant functions. Establish realistic country- and site-level recruitment expectations.
• Evaluate the need for additional sites or countries and collaborate with recruitment vendors, advocacy organizations, or referral networks where appropriate
• Develop, implement, and maintain the study Clinical Monitoring Plan based on the protocol, study design, risk profile, Sponsor expectations, and applicable SOPs.
• Determine appropriate combinations of on-site, remote, centralized, and targeted monitoring activities ensuring monitoring expectations are clearly communicated to CRAs.
• Review monitoring compliance, quality, findings, and trends across sites and countries adapting the monitoring strategy when emerging risks require intervention. Ensure significant findings are escalated and appropriately resolved
• Participate in study-level risk assessment and translate identified risks into an appropriate clinical monitoring strategy. Understand the study's critical data, processes, and Critical-to-Quality factors.
• Attend and actively participate in Bid Defense Meetings to present the proposed Clinical Operations, site management, recruitment, monitoring, and RBM strategies
• Perform monitoring responsibilities as required, based on assigned FTE allocations.
• · Other clinical research duties as required.

  Salary range between $145,000 - $150,000.  Final compensation is based on skills, experience, location, and overall expertise.  

TRAVELING

Global/regional travel on an as-needed basis. Flexibility is required to travel internationally to participate in key Sponsor Bid Defense Meetings, initiate critical global Investigator Meetings, and conduct targeted oversight or escalation visits at high-priority clinical sites.

• Bachelor's or master's degree in life sciences, nursing, or an equivalent field, with 2+ years of clinical trial management experience and a minimum of one year of experience as a clinical monitor.
• Therapeutic knowledge of CNS trial methodologies and scale management.
• Good understanding of the overall drug development process, including study initiation procedures, clinical monitoring functions, drug safety and regulatory requirements, and report generation.
• Proficiency with ICH/GCP guidelines, including E6(R2) and E6(R3), as well as Risk-Based Monitoring and RBQM principles.
• Excellent verbal and written communication, organizational, time-management, customer service, and interpersonal skills.
• Strong global Clinical Operations leadership and end-to-end ownership, with the ability to partner with the Project Manager while maintaining clear Clinical Operations accountability.
• Ability to lead geographically dispersed teams and influence without direct line-management authority.
• Ability to work independently.
• Certified Clinical Research Associate (CCRA), as applicable per regulations.
• Experience in clinical risk management and cross-functional study-delivery leadership.
• Experience participating in proposal development and presenting at bid defense meetings.
• Experience with CTMS and eTMF systems