Senior Clinical Data Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer specialized knowledge in the operational elements of Clinical Data Management for designated clinical trials.

• Assist in activities throughout the clinical study lifecycle and share responsibility with the Clinical Data Lead.

• Design and evaluate Case Report Forms (CRFs), edit checks, reports, and listings.

• Develop documentation, cleanse data, manage inquiries, and identify as well as mitigate risks.

• Serve as a backup for the Clinical Data Lead and provide support to cross-functional teams.

• Implement data strategies and verify adherence to global standards.

• Help monitor and report on the overall progress of the study.

• Thoroughly review study data in accordance with Biogen's processes, regulatory requirements, and study-specific plans.

• Reconcile data gathered in Electronic Data Capture (EDC) systems with safety databases and external vendor systems.

• Investigate discrepancies and suggest appropriate solutions.

• Analyze study metrics, communicate data-related topics across internal and external teams, and escalate issues for prompt resolution.

• Contribute to the creation, enhancement, and innovation of Data Management processes.

• Assist in evaluating vendor quality and efficiency.

• Engage in cross-functional collaborations, study-specific activities, and special projects.

⛳️ Requirements

• A Bachelor's degree is strongly preferred in a scientific field such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.

• A minimum of 4 years of experience in Clinical Data Management is required.

• Extensive technical experience with Electronic Data Capture platforms, preferably Medidata Rave.

• Familiarity with data review tools, ideally Elluminate.

• Project management abilities to effectively collaborate with various business functions.

• Exceptional written and verbal communication skills in English.

• Capability to effectively communicate with a range of cross-functional teams in diverse scenarios.

• Strong attention to detail, with a demonstrated ability to manage multiple competing priorities successfully.

• Knowledge of drug development processes and the biopharmaceutical industry.

• Recognized subject matter expertise among Clinical Data Management peers.

🏝️ Benefits

• Short-term and long-term incentives, including cash bonuses and equity incentive opportunities.

• Medical, Dental, Vision, and Life insurance coverage.

• Fitness and Wellness programs, including reimbursement for fitness-related expenses.

• Short- and Long-Term Disability insurance.

• A minimum of 15 days of paid vacation annually.

• Additional paid time off during the end-of-year shutdown (December 26-31).

• Up to 12 company-paid holidays.

• 3 paid days off for Personal Significance.

• 80 hours of sick leave per calendar year.

• Paid Maternity and Parental Leave benefits.

• Participation in a 401(k) program with company-matched contributions.

• Employee stock purchase plan.

• Tuition reimbursement of up to $10,000 per calendar year.

• Participation in Employee Resource Groups.

• Opportunities for learning, professional growth, and skill development.