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CareDx, Inc. · 4 hours ago

Manager, Clinical Trial Associates & TMF Operations

United States

Full-time

Remote

Mid, Senior Level

$112K/yr - $140K/yr

4+ years exp

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. 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, ensuring inspection-ready documentation and regulatory compliance throughout the clinical trial lifecycle.

BiotechnologyHealth CareHealth DiagnosticsInformation Technology

No H1B

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

Qualification

Clinical Trial Management SystemsTrial Master File (TMF)Clinical Practice (GCP)Regulatory ComplianceISO StandardsClinical Research DocumentationPeople ManagementCommunication SkillsProblem SolvingTime ManagementOrganizational SkillsAttention to Detail

Required

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

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

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

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

Benefits

Health and welfare benefits, including a gym reimbursement program

401(k) savings plan match

Employee Stock Purchase Plan

Pre-tax commuter benefits

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

Company

CareDx, Inc.

CareDx, Inc., headquartered in South San Francisco, is a precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers.

Founded in 1998

Brisbane, California, USA

501-1000 employees