Sr Clinical Data Manager, WCH

Biogen, Inc.; United States; Remote; USD 93,000 - 121,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Wellness program

Disability insurance

Paid vacation

Company holidays

Sick time

Parental leave

401(k) matching

Employee stock purchase plan

Tuition reimbursement

ERGs

Job summary

Biogen, Inc. is seeking a Senior Clinical Data Manager to provide SME support across the clinical lifecycle and back up the Clinical Data Lead.

You will drive data management activities, ensure adherence to Biogen processes, and collaborate with cross-functional teams on study progress and data quality. You will design CRFs and edit checks, manage queries, and support data strategy while maintaining high standards of data integrity and regulatory compliance.

Qualifications

• 4+ years of Clinical Data Management experience.
• Strong experience with EDC platforms such as Medidata Rave.
• Experience using data review tools for data cleaning and validation.
• Project management skills to collaborate with cross-functional teams.
• Excellent written and oral English communication.
• High attention to detail with ability to manage multiple priorities.
• Understanding of drug development and the biopharmaceutical industry.

Responsibilities

• Design and test CRFs, edit checks, reports, and listings.
• Document creation and data cleaning.
• Query management and risk identification.
• Back up to the Clinical Data Lead and support cross-functional teams.
• Apply data strategy and global standards.
• Review study data per Biogen processes and regulatory guidelines.
• Reconcile EDC data with safety databases and external vendor systems.
• Communicate data topics across teams and escalate issues.
• Contribute to Data Management process improvements and new initiatives.
• Assess vendor quality and efficiency including Data Management FSP.
• Participate in cross-functional study activities and special projects.

Skills

CDM experience

Project management

Communication skills

Attention to detail

Drug development knowledge

Cross-functional collaboration

Education

Bachelor’s degree in a scientific discipline

Tools

Medidata Rave

Elluminate

Job description

About This Role

The Senior Clinical Data Manager is a support-level team member and provides subject matter expertise in operational aspects of Clinical Data Management for assigned clinical trials. You will be responsible for activities throughout the clinical study lifecycle and share accountability with the Clinical Data Lead.

What You’ll Do

• Responsible for assigned activities throughout the study lifecycle, such as designing and testing CRFs, edit checks, reports, and listings; document creation; data cleaning; query management; and risk identification and mitigation.
• Act as the back up to the Clinical Data Lead, providing subject matter expertise and support to cross functional teams.
• Applies data strategy, confirms use of global standards, supports cross functional study team members, and assists in monitoring and reporting overall study progress.
• Accountable for comprehensive review of study data, ensuring all tasks are performed according to Biogen processes, regulatory guidelines, and study specific plans.
• Performs or oversees the reconciliation of data collected in EDC with other sources, such as the safety database and external vendor systems.
• Investigates issues and recommends solutions using experience, judgement, and precedent.
• Reviews study metrics and effectively communicates data topics across internal and external teams, escalating relevant issues for timely resolution.
• Contributes to the development of Data Management process, including new process creation, process improvement, and innovation.
• Supports the assessment of vendor quality and efficiency, including Data Management FSP team members and external vendor data providers.
• Participates in cross-functional collaborations, including study level activities and special projects or initiatives.

Who You Are

You are recognized as a subject matter expert amongst Clinical Data Management peers. You enjoy supporting project teams, collaborating through thoughtful communication, and sharing and gaining Clinical Data Management knowledge to positively impact studies, programs, and the organization.

Required Skills

• Bachelor’s degree strongly preferred in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc 4+ years of Clinical Data Management experience required Robust technical experience with Electronic Data Capture platforms (Medidata Rave preferred) and use of data review tools (Elluminate preferred).
• Project management skills to effectively 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.
• Understanding of drug development and the biopharmaceutical industry.

Additional Information

The base compensation range for this role is: $93,000.00-$120,750.00. 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.

• 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 Biogen.

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.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.