Clinical Data Manager
As a Clinical Data Manager at CareDx, you will lead the implementation and execution of clinical data capture, cleaning, and transfer in clinical studies. You will be a member of the Clinical Development Team that works collaboratively to ensure that CareDx’s clinical studies are conducted successfully. Specifically, you will own the primary responsibilities of clinical data completion and integrity.
- Serve as the domain expert in providing clinical data management and electronic data capture (EDC) expertise to support clinical studies
- Design the case report forms (CRFs) in collaboration with the medical and clinical operation team according to clinical protocol and study data requirements
- Develop EDC specifications to implement the CRFs electronically and ensure that the vendor or CRO properly builds the clinical database system through User Acceptance Testing (UAT)
- Provide oversight and management of clinical data management activities throughout the life cycle of a clinical study, including the support of site monitoring and query generation/resolution
- Manage data transfers from the CRO and reporting at required intervals and database locking and archiving at the end of the clinical study
- Coordinate creation of Data Management plan, CRF Completion Guidelines, Data Cleaning Guidelines, Data Transfer Plan, and other clinical data management related documents
- Partner with CRO, site, and EDC vendors to establish processes to ensure study deliverables are met, and the data collection activities satisfy the clinical trial regulation and requirements
- Assist in generating datasets for analysis and reporting by supporting the cross-functional team of different stakeholders.
- BA/BS 4-year degree in science (biological or computer) related discipline; Master’s degree preferred
- 6 years’ experience of clinical data management experience in the industrial or CRO setting
- Strong experience with multiple EDC systems, such as Medrio and RedCap Cloud with programming abilities preferred
- Experience in CRO communications, oversight, and management by working effectively both in a core team and functional team settings
- Knowledge of GCP, ICH Guidelines and use of good clinical data management practices
- Strong analytical skills and business acumen
- Demonstrated problem-solving skills
- Proven experience in establishing and maintaining connections with diverse set of senior contacts
- Must be self-motivated and able to perform tasks and achieve goals with minimum supervision and direction
- Excellent communication and detailed follow-up skills
- The successful candidate will display the following qualities: competent, friendly, self-confident, able to form strong customer relationships, highly ethical
Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.
Our competitive Total Rewards package includes:
- Competitive base salary and incentive compensation
- Health and welfare benefits including a gym reimbursement program
- 401(k) savings plan match
- Employee Stock Purchase Plan
- Pre-tax commuter benefits
- And more!