Manager, Clinical Trial Associates & TMF Operations

CareDx, Inc.

5d•$112,000 - $140,000•Remote

About The Position

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.

Requirements

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
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
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.
Responsible for supervision of CTA team
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

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
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.