Associate Director, Clinical Data Management
Biogen
19 days ago
Remote friendly (United States)
United States
Clinical Research and Development
About This Role
The Associate Director of Clinical Data Management is accountable for Clinical Data Management deliverables across assigned studies and clinical programs, partnering strategically and operating as a leader to define and execute robust data strategies that ensure high-quality data flow, data integrity, and process adherence. Oversees portfolio-level milestones, standards, dashboards, timelines, and resource planning (including input to the annual operating plan). Supports regulatory submissions, drives continuous improvement across programs, and leads or contributes to departmental initiatives/workstreams. Provides talent development through training, coaching, mentoring, and formal people management.
What You’ll Do
- Accountable for Data Management expertise for assigned studies/programs: oversee data quality and performance; ensure consistent implementation of data collection, data cleaning standards, and quality plans.
- Contribute to Data Management department strategy: processes, technology, data standards, reporting, process improvement, and innovation; support related process/system enhancements.
- Hire, assign, and develop staff; provide coaching/mentoring, feedback, career development, and engagement/retention support.
- Serve as escalation point for Data Management activities with cross-functional customers; resolve complex issues and escalate appropriately.
- Research and resolve complex issues; ensure clear, thorough communication.
Required Skills/Qualifications
- Bachelor’s degree (preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.).
- 12+ years in Pharmaceutical/Biotech with focus on Clinical Data Management.
- In-depth drug development/biopharmaceutical industry understanding.
- SME in Clinical Data Management processes, quality management, and data standards development.
- Technical experience with EDC platforms (Medidata Rave preferred) and data review tools (elluminate preferred).
- Strong project management; establish processes/relationships with external stakeholders; influence without authority.
- Experience supporting audits/inspections; strong attention to detail and ability to manage competing priorities.
- Excellent written/oral communication in English.
Benefits (explicitly listed)
- Medical, dental, vision, and life insurance; fitness/wellness programs (fitness reimbursement); short- and long-term disability.
- 15+ days paid vacation; end-of-year shutdown (Dec 26–Dec 31); up to 12 paid holidays + 3 personal significance days.
- 80 hours sick time/year; paid maternity and parental leave; 401(k) with company match; employee stock purchase plan.
- Tuition reimbursement up to $10,000/year; Employee Resource Groups participation.
The Associate Director of Clinical Data Management is accountable for Clinical Data Management deliverables across assigned studies and clinical programs, partnering strategically and operating as a leader to define and execute robust data strategies that ensure high-quality data flow, data integrity, and process adherence. Oversees portfolio-level milestones, standards, dashboards, timelines, and resource planning (including input to the annual operating plan). Supports regulatory submissions, drives continuous improvement across programs, and leads or contributes to departmental initiatives/workstreams. Provides talent development through training, coaching, mentoring, and formal people management.
What You’ll Do
- Accountable for Data Management expertise for assigned studies/programs: oversee data quality and performance; ensure consistent implementation of data collection, data cleaning standards, and quality plans.
- Contribute to Data Management department strategy: processes, technology, data standards, reporting, process improvement, and innovation; support related process/system enhancements.
- Hire, assign, and develop staff; provide coaching/mentoring, feedback, career development, and engagement/retention support.
- Serve as escalation point for Data Management activities with cross-functional customers; resolve complex issues and escalate appropriately.
- Research and resolve complex issues; ensure clear, thorough communication.
Required Skills/Qualifications
- Bachelor’s degree (preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.).
- 12+ years in Pharmaceutical/Biotech with focus on Clinical Data Management.
- In-depth drug development/biopharmaceutical industry understanding.
- SME in Clinical Data Management processes, quality management, and data standards development.
- Technical experience with EDC platforms (Medidata Rave preferred) and data review tools (elluminate preferred).
- Strong project management; establish processes/relationships with external stakeholders; influence without authority.
- Experience supporting audits/inspections; strong attention to detail and ability to manage competing priorities.
- Excellent written/oral communication in English.
Benefits (explicitly listed)
- Medical, dental, vision, and life insurance; fitness/wellness programs (fitness reimbursement); short- and long-term disability.
- 15+ days paid vacation; end-of-year shutdown (Dec 26–Dec 31); up to 12 paid holidays + 3 personal significance days.
- 80 hours sick time/year; paid maternity and parental leave; 401(k) with company match; employee stock purchase plan.
- Tuition reimbursement up to $10,000/year; Employee Resource Groups participation.