Sr. Principal, Clinical Data Lead (San Francisco)

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Sr. Principal, Clinical Data Lead

Apply remote type Hybrid locations San Francisco, CA time type Full time posted on Posted Yesterday job requisition id REQ21406

Biogens 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.

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 will provide operational leadership and be accountable for all Clinical Data Management activities throughout the clinical study lifecycle.

What Youll Do

• Single 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 clinical study lifecycle. This includes oversight of all Data Management tasks and will also include 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.

• Reviews operational metrics and trends and initiates process and efficiency optimization.

• 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 on study teams and for special projects, providing Data Management expertise and highlighting.

• Supports special projects and 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 trials, programs, and the organization.

Required Skills

• Bachelors degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc..

• 7+ years relevant work experience within the pharmaceutical/biotech industry, with a focus on clinical data management, 4+ years as a Trial 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, such as J-Review or Business Objects.

• Strong project management skills and ability to effectively lead and collaborate with various business functions.

• Strong written and verbal communication skills and the ability to communicate to 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 biopharmaceutical industry.

Job Level: Management

Additional Information

The base compensation range for this role is: $138,000.00-$185,000.00

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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

#TeamBiogen

Were united by a shared purpose, proud of our work, and inspired by one another and the lives we strive to change.

Perks of Biogen

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission.

Caring Deeply. Achieving Excellence. Changing Lives.

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