Principal Data Scientist
Medtronic
PythonTableau
Principal Clinical Data Lead
Biogen
full-time
Posted on:
Location Type: Hybrid
Location: Research Triangle Park • Massachusetts, North Carolina • 🇺🇸 United States
Visit company websiteSalary
💰 $113,000 - $175,000 per year
Job Level
Senior
About the role
- Provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials
- Manages the flow of all Clinical Data throughout the clinical study lifecycle, from initial Case Report Form (CRF) development to Clinical Study Reporting (CSR)
- Ensure effective project planning, risk management and provision of high-quality data deliverables
- Leads the design and development of eCRFs, ensuring adherence to Biogen standards throughout
- Coordinates the development and testing of data management system edit checks and the listings/reports/tools utilized for the data review and discrepancy management activities
- Develops Data Management Plan documents utilized to deliver accurate, timely, consistent, and quality clinical data
- Acts as the primary and accountable Data Management (DM) representative to the study management team
- Partners with key cross functional team members to develop and implement project plans for assigned studies
Requirements
- 7+ years relevant work experience with a focus on clinical data management with full accountability across study start-up, conduct, and lock for Principal Clinical Data Lead
- 10+ years relevant work experience with a focus on clinical data management with full accountability across study start-up, conduct, and lock for Senior Principal Clinical Data Lead
- Robust experience with EDC (E.g. Medidata Rave) and use of Data Review tools such as eCS elluminate
- Deep understanding of drug development and biopharmaceutical industry required
- Exceptional project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
- High attention to detail including proven ability to manage multiple, competing priorities
- Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor
- Deep knowledge of clinical data management outsourcing operating model to functional-service providers and full-service/global CROs
- Demonstrated ability to influence without authority
- Excellent written and oral communication skills
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Clinical Data ManagementCase Report Form (CRF) developmentClinical Study Reporting (CSR)eCRF design and developmentData Management Plan developmentData Review toolsEDC (Electronic Data Capture)Medidata Ravedata management system edit checksdiscrepancy management
Soft skills
project managementleadershipcollaborationattention to detailability to manage multiple prioritiesrelationship buildinginfluence without authoritycommunication skills
Certifications
project management certification
