Clinical Trial Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee the complete execution of CareDx clinical trials, encompassing site identification, study initiation, conduct, monitoring, and closure.

• Manage study timelines, budgets, metrics, IRB/EC submissions, study documentation, and meetings specific to the study.

• Propel site activation, enrollment, and the overall performance of the study.

• Identify potential study risks, lead mitigation strategies, and escalate operational challenges with actionable plans and accountability.

• Review investigator contracts and payments as necessary.

• Coordinate efforts among Clinical Operations, Data Management, Medical Affairs, and other relevant functions.

• Prepare and deliver project debriefings to management and cross-functional teams.

• Supervise Clinical Research Associates, CROs, central laboratories, and external vendors through governance, KPIs, and performance management.

• Standardize execution across studies, enhance vendor management and reporting, and implement process improvements and SOPs.

• Ensure data quality and readiness for inspection by reviewing data, tracking metrics, and collaborating with monitoring and data management teams.

• Maintain communication with clinical sites and stakeholders, oversee site visits and documentation, and ensure compliance with GCP, regulatory standards, and protocols.

• Support site engagement, training, and management of product inventory.

• Ensure comprehensive, high-quality eTMF documentation and real-time reporting on study status.

• Oversee the use of CTMS for tracking study milestones, enrollment, monitoring activities, and performance metrics.

• Directly lead and manage clinical operations personnel.

• Travel approximately 10–30% as required.

⛳️ Requirements

• Bachelor’s degree in life sciences, health sciences, or a related field/experience.

• A minimum of 4 years of experience in clinical trial management.

• At least 2 years of experience as a clinical research associate with on-site/remote clinical monitoring in the biotechnology, pharmaceutical, or CRO sectors.

• Minimum of 2 years of direct experience managing, coaching, and developing clinical operations professionals.

• Strong understanding of ICH/GCP guidelines and regulatory requirements.

• Familiarity with medical terminology.

• Experience with medical laboratory testing and documentation of patient information.

• Comfortable utilizing technology along with scientific and engineering principles.

• Strong skills in clinical study and project management.

• Excellent communication, writing, organizational, problem-solving, conflict-resolution, leadership, and team-building skills.

• Ability to work independently, take initiative, and achieve objectives within set timelines and budget.

• Capability to mentor staff, drive accountability, manage priorities, and support clinical study execution.

• Ability to work across different time zones and manage multiple tasks.

• In-depth knowledge of FDA regulations and GCP standards.

• Proficiency in Microsoft Office, EDC software such as Medrio and Medidata, eTMF, CTMS, and safety-report platforms.

• RN or pharmaceutical experience is preferred but not mandatory.

• Experience with organ transplantation clinical studies is preferred.

🏝️ Benefits

• Competitive base salary along with incentive compensation.

• Comprehensive health and welfare benefits.

• Gym reimbursement program.

• 401(k) savings plan with matching contributions.

• Employee Stock Purchase Plan.

• Pre-tax commuter benefits.

• Up to 30 days of paid leave annually for full-time employees who donate an organ or bone marrow.

• Additional discretionary bonuses/incentives and restricted stock units may be available.