Clinical Data Manager
Clinical Data Manager
Today, the biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $100M+. And the problem is only getting worse.
At TrialSpark, we don’t believe it has to be this way. Through technology and a new operational model, we’re reimagining how clinical trials are run, with the mission of bringing new treatments to patients faster.
We do this by partnering with physicians to enable them to run clinical trials within their existing practices. By providing the technology platform, equipment, and staffing, TrialSpark alleviates the operational burden of clinical research, enabling physicians to focus on what they do best -- patient care. And by bringing clinical research to physician practices, TrialSpark is enabling access for the 98% of patients who are never exposed to clinical trial opportunities.
About the role
The Clinical Data Manager (CDM) role is critical to the success of the studies TrialSpark is engaged in. The CDM oversees all facets of clinical data management of studies, from feasibility to closeout. They are responsible for ensuring that high-quality data is collected through design, validation and cleaning of the systems involved.
- Translate protocols into eCRF and eSource specifications
- Write UAT test scripts for eCRF and eSource forms
- Perform/execute User Acceptance Testing
- Track database set-up, testing, maintenance and data entry metrics
- Communicate with internal project teams and vendors on data management matters
- Review study documents, design and develop project specific guidelines and instructions
- Design eCRF, Data Management and Data Validation Plans and test EDC databases
- Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation
- Code medical data
- Track and report metrics leading to database lock
- Coordinate the processing, dispatch and archiving of CRFs/queries
- Maintain Clinical Data Management working files
- Perform database QC checks, prepare and attend audits
- Train internal project teams on CRF completion and data management topics
- Serve as an SME for clinical data management activities
- College/University degree, or equivalent combination of experience and education
- Prior experience with clinical data (3+ years minimum)
- Experience with Clinical Data Management systems (Medidata Rave, Oracle InForm, ClinTrial)
- Working knowledge of CDISC and SDTM
- Ability to write test scripts for User Acceptance Testing (UAT)
- Ability to conduct data review in accordance with the study protocol and DMP
- Ensure compliance with regulatory requirements and GCP
- Organizational and time management skills
- Ability to work independently and multi-task
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status