Caredxinc
Clinical Trial Manager
Brisbane, CA
Sponsorship not specified$10k-$30kDetected 7 days ago
GCPProject ManagementExcelOperations ManagementProcess ImprovementVendor ManagementInventory ManagementPerformance ManagementClinical TrialsClinical ResearchClinical Laboratory TechniquesFDA RegulatoryBioinformaticsResearchLeadershipCommunicationCollaborationProblem SolvingOrganizational SkillsMicrosoft Office
About the role
- 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.
- This position provides direction and operational leadership of the clinical research studies to ensure delivery on time.
Responsibilities
- Drive site activation, enrollment, and overall study performance while ensuring alignment with protocols, operational plans, and business objectives.
- Proactively identify study risks (timeline, quality, and operational), lead mitigation planning and execution, and escalate issues effectively with clear action plans, defined ownership, and accountability
- Support study administration activities such as site engagement, training, and product inventory management to ensure efficient and compliant study execution.
- Ensure high-quality, inspection-ready documentation and study tracking through effective use of eTMF including oversight of TMF completeness, document quality, and real-time study status reporting
- Provide oversight and operational support for CTMS system and effective use of it for tracking study milestones, enrollment, monitoring activities, and performance metrics
- Maintain strong communication with clinical sites and stakeholders, including oversight of site visits, study documentation, and reporting, while ensuring compliance with GCPs, regulatory requirements, and study protocols.
Requirements
- Robust understanding of ICH/GCP, and knowledge of regulatory requirements.
- and participates in process improvement initiatives as required.
Nice to have
- RN or pharmaceutical experience preferred but not required
Skills
- A critical thinker and capable of problem solving and aligning the priorities with study outcomes and timelines.
- Strong clinical study/project management skills.
- Ability to motivate and collaborated with teams at other functional departments.
- Ability to work independently, take initiative, and meet company goals within timelines and budget.
- Able to work in a fast-paced environment with multiple competing tasks and demands, across time-zones.
- Must have a sense of urgency about problem-solving and completing projects.
- Ability to communicate with vendors and keep a high quality of clinical study
- Strong knowledge of FDA regulations and GCP.
- Travel estimate 10-30%.
- Operate within standard guidelines, but must engage in some independent decision-making.
- Errors that are not quickly detected and rectified could have a significantly adverse effect on the quality of the study.
- Works closely with other Clin
Compensation
- $10k-$30k
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This listing is sourced directly from Caredxinc's careers page and normalized into a canonical job model.