Sr. Principal, Clinical Data Lead

Biogen•San Francisco, CA

1d•$131,000 - $185,000

About The Position

About This Role Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. 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. Developes 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 Are You 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.

Requirements

Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
7+ years relevant work experience with a focus on Clinical Data Management.
4+ years 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 is required.
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.

Responsibilities

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.
Developes 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.

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