Biogen

Senior Principal, Clinical Data Lead

Biogen

full-time

Posted on:

Location Type: Remote

Location: Remote • California, Massachusetts • 🇺🇸 United States

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Salary

💰 $131,000 - $185,000 per year

Job Level

Senior

About the role

  • 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.

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.
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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Data ManagementClinical Data ManagementElectronic Data Capturedata cleaningquery managementrisk identificationprocess improvementdata review toolsproject managementstudy metrics
Soft skills
communication skillsattention to detailcollaborationleadershipproblem-solvingtime managementorganizational skillsjudgmentinnovationcross-functional teamwork