Manager, Clinical Data Management
The Manager, Data Management provides oversight of data management tasks from study start-up through database lock. Collaborates with the clinical operations team and data management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines. This position reports to the Director of Clinical Data Management.
- Provide oversight of data management vendors and CROs
- Review clinical study protocols, ensure protocol compliance, and provide input relevant to data management issues
- Oversee the process of Electronic Case Report Forms (eCRF) development
- Review clinical study startup documents: Data Management Plan (DMP), Case Report Form Completion Guidelines (CCGs), Data Validation Specifications (DVS) including system queries and manual reviews, Data Transfer Agreements (DTA), etc.
- Perform User Acceptance Testing (UAT) on new clinical study databases including the testing of complex system queries
- Perform individual data review and assist in orchestration of cross-functional team data review
- Create and maintain study status reports for tracking eCRF completion, discrepancy management, and other study metrics as needed
- Manage the timely entry of data, oversee the study team data review process, and the locking of subject data
- Help identify inconsistencies and inefficiencies in data management processes and recommend solutions
- Attend team meetings as needed to represent CDM interests
- Bachelor’s degree in Life Sciences or Mathematics, combination of relevant education and applicable job experience may be considered
- 7 years of experience in management of CDM activities and with clinical trial methodology and Good Clinical Practice (GCP), with some experience at a pharmaceutical or biotechnology company
- Technical competency using data management systems, especially EDC systems
- Demonstrated ability to manage a complex workload and prioritize tasks based on program goals.
- Strong verbal and written communications skills, as well as problem-solving skills
- Ability to work quickly and independently and as a strong team player
- Experience in Infectious Disease or Oncology therapeutic areas
- CRO background in addition to sponsor side experience
- Phase 3 clinical trial experience
The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.
Cidara Therapeutics is an EEO/AA/Disability/Vets Employer and an E-Verify Company