Director, Data Management
Alkermes
August 20, 2026
Remote friendly (Greater Boston)
United States
IT
Responsibilities:
- Provide strategic and operational leadership for Clinical Data Management across all clinical development programs.
- Plan, coordinate, and oversee Data Management deliverables for internally managed studies.
- Provide sponsor oversight for CRO-managed studies and govern external Data Management vendors.
- Establish and monitor vendor performance via KPIs, quality metrics, timelines, issue management, and governance meetings.
- Oversee end-to-end clinical trial database design, build, validation, testing, deployment, and maintenance (ICH-GCP, regulatory, company standards).
- Develop study-level Data Management strategies (data collection approaches, risk-based data cleaning, database quality objectives).
- Ensure inspection readiness of Clinical Data Management Trial Master File (TMF) documentation and deliverables.
- Establish standards for eCRF design, CDASH, controlled terminology, data collection conventions, and CDISC-compliant outputs.
- Oversee key documentation (DMPs, DVS, edit checks, manual data review, data review plans, database lock).
- Partner with Biostatistics/Statistical Programming to deliver quality datasets (cleaning, queries, SAS listing review, TLF dry runs, lock).
- Develop and communicate departmental performance metrics; lead initiatives (SOPs, standards, systems, optimization, automation, data integration, governance).
- Evaluate new technologies/best practices; support RBQM/centralized monitoring as applicable.
- Recruit, mentor, and manage Data Management staff; represent Data Management on cross-functional governance committees.
Qualifications:
- Bachelor’s degree (Life Sciences/Health Sciences/Computer Science/Clinical Research or related).
- 10+ years data management in pharma/biotech (at least 3 years supervisory/leadership); CCDM preferred.
- Lead Data Manager (or equivalent) with end-to-end experience across multiple studies.
- Experience with global trials and geographically distributed teams.
- Advanced GCP/ICH knowledge and 21 CFR Part 11.
- Strong leadership, cross-functional collaboration, and organizational/interpersonal/multi-tasking skills.
Hybrid/Compensation:
- Hybrid: ~60% office / 40% home; onsite at Waltham, MA at least 3 days/week; not fully remote.
- Base salary: $205,000–$230,000; eligible for annual performance bonus; competitive benefits package.
- Provide strategic and operational leadership for Clinical Data Management across all clinical development programs.
- Plan, coordinate, and oversee Data Management deliverables for internally managed studies.
- Provide sponsor oversight for CRO-managed studies and govern external Data Management vendors.
- Establish and monitor vendor performance via KPIs, quality metrics, timelines, issue management, and governance meetings.
- Oversee end-to-end clinical trial database design, build, validation, testing, deployment, and maintenance (ICH-GCP, regulatory, company standards).
- Develop study-level Data Management strategies (data collection approaches, risk-based data cleaning, database quality objectives).
- Ensure inspection readiness of Clinical Data Management Trial Master File (TMF) documentation and deliverables.
- Establish standards for eCRF design, CDASH, controlled terminology, data collection conventions, and CDISC-compliant outputs.
- Oversee key documentation (DMPs, DVS, edit checks, manual data review, data review plans, database lock).
- Partner with Biostatistics/Statistical Programming to deliver quality datasets (cleaning, queries, SAS listing review, TLF dry runs, lock).
- Develop and communicate departmental performance metrics; lead initiatives (SOPs, standards, systems, optimization, automation, data integration, governance).
- Evaluate new technologies/best practices; support RBQM/centralized monitoring as applicable.
- Recruit, mentor, and manage Data Management staff; represent Data Management on cross-functional governance committees.
Qualifications:
- Bachelor’s degree (Life Sciences/Health Sciences/Computer Science/Clinical Research or related).
- 10+ years data management in pharma/biotech (at least 3 years supervisory/leadership); CCDM preferred.
- Lead Data Manager (or equivalent) with end-to-end experience across multiple studies.
- Experience with global trials and geographically distributed teams.
- Advanced GCP/ICH knowledge and 21 CFR Part 11.
- Strong leadership, cross-functional collaboration, and organizational/interpersonal/multi-tasking skills.
Hybrid/Compensation:
- Hybrid: ~60% office / 40% home; onsite at Waltham, MA at least 3 days/week; not fully remote.
- Base salary: $205,000–$230,000; eligible for annual performance bonus; competitive benefits package.