Manager, Clinical Trial Associates & TMF Operations

CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.

The Manager, Clinical Trial Associate (CTA), TMF Operations is responsible for leading the preparation, execution, and oversight of clinical trial documentation and regulatory operations across assigned studies. Serving as the subject matter expert for the Trial Master File (TMF), this role provides strategic leadership to CTA teams to ensure inspection-ready documentation, regulatory compliance, and operational excellence throughout the clinical trial lifecycle.

This position oversees TMF operations and, where applicable, CTMS management. ensures alignment with global regulatory requirements (ISO, ICH, GCP), and drives continuous inspection readiness through rigorous quality oversight, audit preparation, and reconciliation of the TMF and Investigator Site File (ISF). The Manager partners cross-functionally with Clinical Operations, Regulatory, Data Management, and external study partners to support site initiation, monitoring, and close-out activities, while maintaining the integrity, accuracy, and completeness of all essential documents.

As a people leader, this role is responsible for the supervision, training, and development of CTA staff, proactively managing workload, resourcing, and performance to maintain high standards of quality, timeliness, and compliance. The Manager applies critical thinking to resolve complex regulatory and operational challenges, escalates risks as needed, and provides transparent study reporting in internal and external forums. Decisions made in this role have lasting impact on TMF strategy, inspection outcomes, and overall study success.
Responsibilities:

• Lead in the preparation and execution of clinical trial documents, including protocols, informed consent forms, and case report forms
• Lead in supporting the study teams in site initiation, monitoring visits, and study close-out activities pertaining to regulatory documentation.
• Ensure proper documentation and compliance with regulatory requirements (e.g. ISO, ICH, GCP)
• Support in the preparation of clinical trial reports and regulatory submissions
• Ensure proper storage, handling, and maintenance of clinical trial documentation in Study Trial Master File (TMF) and confirmation of reconciliation of Investigator Site File (ISF)
• Owns and manages TMF, and CTMS (as applicable) systems for respective studies
• Lead the preparation, organization, and maintenance of ISF and TMF for audits, ensuring continuous inspection readiness.
• May lead other administrative activities as per study need
• Provide guidance and/or training and onboarding to junior level CTA and other staff as applicable
• Ability to report on respective studies in internal/external meetings as applicable
• Responsible for management of direct reports
• Subject matter expert (SME) for TMF
• Manage user access for TMF
• Build and maintain TMF classifications and guidance documents

Knowledge:

• Excellent knowledge of ALCOA++, ISO, ICH, and GCP
• Demonstrated success achieving results as an engaged team member in diverse, fast-paced, and high-intensity study and functional environments.
• Strong verbal and written communication skills. 
• Strong knowledge of all phases of clinical trial design, with specific expertise in medical device studies in organ transplantation.
• Excellent knowledge of essential clinical trial documentation such as case report forms (CRFs), informed consent forms, and study protocols.
• Excellent knowledge of site initiation, monitoring, and close out procedures.
• Ability to track and ensure that clinical sites are compliant with the local and country regulatory requirements, and GCP.
• Excellent understanding of clinical trial lifecycle.
• Proficiency in using Clinical Trial Management systems and Electronic Data capture systems.
• Excellent knowledge in build and maintenance of TMF systems and classifications
• Excellent knowledge of audit requirements
• SME of TMF

Problem Solving/Job Complexity

• Ability to identify and address, resolve and/or escalate any issues that may arise pertaining to regulatory compliance and role associated tasks.
• Ability to critically think in a face past environment.

Discretion/Latitude and Supervision

• Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness
• Participates in arranging own activities in accomplishing objectives
• In collaborative settings, ability to provide status updates pertaining to tasks
• Responsible for supervision of CTA team

Impact

• Decisions are long-lasting and impact the future course of the trial master file and encompassing goals
• Errors in judgment or failure to achieve results may require some expenditures of resources to rectify
• Ensure adequate resourcing across all assigned studies by assessing workload, prioritizing tasks, and allocating team members appropriately.
• Proactively identify gaps in capacity and escalate or request additional resources as needed to maintain timelines and quality standards.

Liaison

• Must be able to work in a team environment, including immediate supervisor and other team members in multidisciplinary group
• Ability to build stable working relationships internally and externally
• Must be able to provide site staff with training and resources related to the protocol and study procedures.
• Must be able to lead a group of CTAs or other designees

Typical Education/Experience

• Degree/certification in life sciences, health sciences, or equivalent degree/experience (e.g., BA/BS) or equivalent experience
• Proficiency with updating and navigating clinical Trial Master File and Clinical Trial Management Systems.
• Minimum 4+ years of experience in clinical research documentation
• Minimum 2+ years of experience in people management
• Excellent knowledge of Good Clinical Practice (GCP), FDA regulations, and ISO standards
• Working knowledge of medical terminology.
• Excellent in Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint).
• Strong time-management, documentation, and organizational skills
• Must be detail- and accuracy-oriented.
• Must have high standards for quality of work.
• Strong verbal communication skills and effective writing skills.
• Successful history in a team-oriented environment and yet able to work independently.
• Must have a sense of urgency about problem-solving and completing projects.
• Strong experience managing a team of CTAs
• Experience in audit readiness

Additional Details: 

Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients. 

Our competitive Total Rewards package for US Employees includes:

• Competitive base salary and incentive compensation
• Health and welfare benefits, including a gym reimbursement program
• 401(k) savings plan match
• Employee Stock Purchase Plan
• Pre-tax commuter benefits
• And more!
• Please refer to our page to view detailed benefits at https://caredx.com/company/careers

In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.

With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.

CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.

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