[Remote] Manager, Clinical Trial Associates & TMF Operations

Note: The job is a remote job and is open to candidates in USA. 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.

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

Skills

• 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 Overview

• 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. It was founded in 1998, and is headquartered in Brisbane, California, USA, with a workforce of 501-1000 employees. Its website is https://www.caredx.com/.

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