About This Role The Senior Principal, Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They provide operational leadership and are accountable for all Clinical Data Management activities throughout the clinical study lifecycle.
What You'll Do - Primary point of contact for the execution of Data Management deliverables on assigned trials and programs. Interprets and applies data strategy, ensures use of global program standards, coordinates and oversees Data Management study team members, and monitors and reports overall study progress.
- Accountable for all Data Management activities throughout the study lifecycle. This includes oversight of all Data Management tasks and performing tasks such as document creation, data cleaning, and query management.
- Accountable for Data Management standards across assigned trials and programs. Ensures high utilization of CRF and edit check standards library components.
- Develops and executes plans for risk identification and mitigation.
- Assesses operational metrics to optimize process efficiency.
- Assesses study metrics and effectively communicates data topics across internal and external teams, escalating relevant issues for timely resolution.
- Oversees issue investigation and solution proposals using experience, judgement, and precedent.
- Contributes to the development of Data Management process, including new process creation, process improvement, and innovation as applicable.
- Manages quality and efficiency performance with vendors, including Data Management FSP team members and external vendor data providers. Develops and implements strategies and plans for improvement when needed.
- Leads and participates in cross-functional collaborations, including study level activities and special projects or initiatives.
Who You AreYou are recognized as an operational specialist in Clinical Data Management and study execution by cross-functional groups. You enjoy leading project teams, collaborating through thoughtful communication, and sharing Clinical Data Management knowledge to positively impact studies, programs, and the organization.
Required Skills - Bachelor's degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
- 7+ years' experience in Clinical Data Management within the biopharmaceutical industry.
- 4+ years' experience as a Lead Data Manager with full accountability across study start-up, conduct, and lock.
- Robust technical experience with Electronic Data Capture platforms (Medidata Rave preferred) and use of data review tools (elluminate preferred).
- Strong project management skills to effectively lead and collaborate with various business functions.
- Excellent written and oral communication skills in English.
- Ability to effectively communicate with a variety of cross-functional teams in a variety of scenarios.
- High attention to detail, including proven ability to manage multiple competing priorities successfully.
- Deep understanding of drug development and the biopharmaceutical industry.
Job Level: Management
Additional InformationThe base compensation range for this role is: $134,000.00-$179,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Job Level: Management
