Senior Clinical Trial Manager

The Senior Clinical Trial Manager (Sr. CTM) position oversees and performs day-to-day site management activities, after site activation, on clinical research trials. The Sr. CTM acts as the site liaison between the Project Manager and a group of Clinical Research Associates (CRAs) assigned to a given clinical trial, and with collaboration from the team, ensures the clinical site portion of a trial is always inspection ready. This role also performs leadership activities and provides operational support to department heads.

Essential Functions:

Leadership:

•Support and mentor CTM I and II while providing clinical site management oversight on a trial and relational basis.

•Assist other departments or functional areas including Finance, Business Operations, Clinical Development, Site Engagement, Data Services, Data Management, Vendor Management, and Quality Assurance by serving a subject matter expert in site management.

•Support Principal CTM with performance metrics, operational efficiencies, process improvements, resourcing and utilization, training, and other tasks as needed or assigned.

General:

•Ensure compliance with FDA and ICH GCP regulations, Sponsor guidelines, and all internal controlled documents.

•Ensure accurate time completion on a weekly basis in accordance with trial budgets and scopes.

•Assist with the development and implementation of TD2 clinical policies, SOPs, working guidelines, training manuals, and informal processes.

Trial:

•Effectively communicate with project and senior management on strategies to grow site services business at TD2.

•Collaborate with cross-functional team members and trial sites throughout all trial phases.

•Review protocol, amendments, plans, manuals, and other trial documents as necessary.

•Develop trial Patient Recruitment, Enrollment, and Retention Plans. Ensure individual site profiles appendixes are completed and support site triage and services upon activation.

•Prepare and review site-related reports (e.g., enrollment, deviation logs, monitoring trackers, and interim monitoring).

•Provide site metrics as needed for decision making purposes.

•Lead regular Investigator meetings, create agendas, review meeting minutes, update Project Log, and ensure distribution as agreed upon with the Sponsor.

•Work with the Project Manager and Sponsor to proactively identify site risks, developing mitigation and contingency planning.

•Participate in Sponsor meetings and Internal Team meetings, serving as subject matter expert in site management including enrollment, and reviewing agendas, minutes, and the Project Log as needed for site information.

Quality:

•Represent TD2 during quality audits with specific focus on site management activities at TD2.

•Immediately escalate any site, patient, or trial safety or conduct concerns to project manager and department leadership for awareness and assistance.

Site Management:

•Develop and maintain Sponsor and site relationships that result in repeat business.

•Serve as primary liaison between sites, Project Manager, CRAs, or other designated team members for site non-compliance and issue resolution (e.g., recruitment, enrollment, documentation, data entry timeliness, query follow-up, investigational product (IP), laboratory samples and kit logistics, and general miscommunications).

•In collaboration with the CRAs, proactively identify site issues and coordinate personnel retraining to avoid major deviation occurrences or recurrences.

•Review and approve interim monitoring trip reports initially completed by CRA or designated individual.

•Track projected versus actual enrollment, providing solution-based site support and customized interventions to boost patient recruitment, screening, enrollment, and retention.

•Work with site personnel to proactively address potential or actual barriers to patient recruitment, screening, enrollment, and retention, collaborating with Site Engagement or other designated individuals.

•Responsible for site budgets, regulatory submissions and approvals, site ICF revisions, site document distribution, and site training with protocol amendments.

•Responsible for the post site-activation site milestone tracking in the detailed trial timeline. Monitor and coordinate the efforts of the key site milestones to ensure they are met on time.

IP, Supplies, and Specimen Management:

•Serve as main contact for site clinical trial supplies IP, communicating with respective vendors for coordination and inventory reconciliation, not including budget or change orders.

Perform other related duties as assigned.

Job Requirements:

• Minimum of a Bachelor’s degree in a life science, or health related with Master’s degree preferred. Experience may be substituted for education at TD2’s discretion.
• Minimum of 6 years’ experience in research.
• Minimum 4 years’ experience in oncology research trials from biotechnology/pharmaceutical, clinical research organization, and/or site setting.
• Experience in other complex therapeutic areas, such as rare and orphan diseases, cardiac, or AME trials, as well TD2 performance and work experience, may be substituted at TD2’s discretion.
• Evidence of understanding aspects of clinical trials.

Required Specialized/Technical Skills:

• Understanding of oncology clinical trials with strong knowledge of the clinical drug development process.
• Familiarity and training in all aspects of clinical trial research, including GCP/ICH guidelines.
• Understanding of CRA activities and responsibilities.
• Ability to train and lead the work of others.
• Excellent communication, written and interpersonal skills.
• Strong ability to perform individually, work collaboratively with team members, and build excellent relationships with Sponsors, sites, and other TD2 team members.
• Possess strategic thinking, contingency planning, problem-solving and dispute resolution skills.
• Good organization and multi-tasking skills in a fast-paced environment.
• High-level skills in communication, judgement, problem-solving, persuading, and negotiating.
• Strong computer skills, including Microsoft Excel, Word, and PowerPoint.
• Experience using required electronic systems (e.g., CTMS, TMF, EDC)
• Ability to travel approximately 15% (dependent on Sponsor/trial requirements).

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.

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