Director, Clinical Data Management — Hybrid Leader

Alkermes; Massachusetts; Hybride; USD 205 000 - 230 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Competitive benefits

Résumé du poste

Alkermes is seeking a Director of Clinical Data Management to provide strategic leadership across all clinical development programs and to ensure high-quality, inspection-ready data. The role partners with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, and external vendors to define study-level data strategies and ensure regulatory compliance.

You will oversee DM deliverables for internal studies and sponsor oversight for CRO studies, establishing KPIs and

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Computer Science, Clinical Research, or a related discipline required.
• Minimum 10 years data management experience in pharmaceutical/biotech; at least 3 years in supervisory/leadership roles (CCDM preferred).
• Lead Data Manager or equivalent with end-to-end data management ownership across multiple studies.
• Experience managing global trials and cross-functional/geographically distributed teams.
• Advanced knowledge of GCP/ICH standards, 21 CFR Part 11.
• Strong leadership and ability to work in cross-functional teams.
• Excellent interpersonal, organizational, and multi-tasking skills.

Responsabilités

• Provide strategic and operational leadership for Clinical Data Management across all programs.
• Plan, coordinate, and oversee Data Management deliverables for internally managed studies.
• Oversee sponsor oversight for CRO studies and governance of external Data Management vendors.
• Establish and monitor vendor performance via KPIs, quality metrics, timelines, and issue management.
• Oversee design, build, validation, testing, deployment, and maintenance of clinical trial databases per ICH-GCP and company standards.
• Develop study-level Data Management strategies including data collection, risk-based cleaning, and CDISC outputs.
• Ensure inspection readiness of all Data Management TMF documentation and deliverables.
• Collaborate with Biostatistics and Statistical Programming to ensure timely high-quality datasets.

Connaissances

Data management

Leadership

Cross-functional teams

Regulatory compliance

GCP/ICH

Vendor management

Formation

Bachelor's degree

Description du poste

Alkermes is seeking a Director of Clinical Data Management to provide strategic leadership across all clinical development programs and to ensure high-quality, inspection-ready data. The role partners with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, and external vendors to define study-level data strategies and ensure regulatory compliance.

You will oversee DM deliverables for internal studies and sponsor oversight for CRO studies, establishing KPIs and