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TD2 Oncology · 1 day ago

Senior Clinical Trial Manager

United States

Full-time

Remote

Senior Level

$115K/yr - $130K/yr

6+ years exp

TD2 Oncology is a leading oncology CRO focused on developing novel treatments for patients. The Senior Clinical Trial Manager (Sr. CTM) oversees site management activities for clinical research trials, ensuring compliance and operational support while mentoring junior CTMs and collaborating with various departments.

BiotechnologyHealth CareOncologyPharmaceuticalTest and Measurement

Responsibilities

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

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

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

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

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

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

Qualification

Oncology clinical trialsClinical drug developmentGCP/ICH guidelinesCRA activitiesClinical trial researchMicrosoft ExcelMicrosoft WordMicrosoft PowerPointLeadershipCommunication skillsProblem-solvingOrganizational skillsTeam collaboration

Required

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

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)

Company

TD2 Oncology

TD2 Oncology is an oncology-focused Contract Research Organization (CRO) that supports improved and accelerated development of medicines for life-threatening diseases.

Founded in 2003

Scottsdale, Arizona, USA

51-200 employees