Director, Data Management

Alkermes

1d•Hybrid

About The Position

This role provides strategic and operational leadership for Clinical Data Management activities supporting the company's clinical development portfolio. This position is responsible for ensuring the delivery of high-quality, reliable, and inspection-ready clinical data through effective planning, oversight, and execution of data management activities across both internally managed and outsourced clinical studies. The Director partners closely with cross-functional stakeholders, including Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Clinical Systems, Quality Assurance, and external vendors, to define study-level data management strategies, ensure regulatory compliance, and drive continuous process improvements. This position also provides leadership for departmental initiatives, people development, and operational excellence.

Requirements

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

Nice To Haves

CCDM preferred

Responsibilities

Provide strategic and operational leadership for Clinical Data Management activities across all clinical development programs.
Plan, coordinate, and oversee all Data Management deliverables for internally managed clinical studies.
Provide sponsor oversight for CRO-managed studies and ensure effective governance of external Data Management vendors.
Establish and monitor vendor performance through defined KPIs, quality metrics, timelines, issue management, and governance meetings.
Oversee the design, build, validation, testing, deployment, and maintenance of clinical trial databases in compliance with ICH-GCP, applicable regulatory requirements, and company standards.
Develop study-level Data Management strategies, including data collection approaches, risk-based data cleaning methodologies, and database quality objectives.
Ensure inspection readiness of all Data Management Trial Master File (TMF) documentation and deliverables.
Establish, implement, and maintain standards for eCRF design, CDASH implementation, controlled terminology, data collection conventions, and CDISC-compliant data outputs.
Provide oversight for key Data Management documentation, including Data Management Plans (DMPs), Data Validation Specifications (DVS), edit check specifications, manual data review guidelines, data review plans, and database lock documentation.
Collaborate closely with Biostatistics and Statistical Programming to ensure timely delivery of high-quality datasets through effective data cleaning, query management, SAS listing review, TLF dry runs, and database lock activities.
Develop, monitor, analyze, and communicate departmental performance metrics and quality indicators to support continuous improvement.
Lead departmental initiatives related to SOP development, inspection readiness, data standards, system implementation, process optimization, automation, data integration, and clinical data governance.
Evaluate and implement innovative technologies and industry best practices to improve Data Management efficiency and quality.
Contribute to Risk-Based Quality Management (RBQM) strategies and centralized monitoring initiatives, as applicable.
Recruit, mentor, coach, and develop Data Management staff while fostering a culture of accountability, collaboration, and continuous learning.
Provide direct people management, including performance management, goal setting, succession planning, career development, resource planning, and organizational growth.
Represent Data Management on cross-functional governance committees and provide strategic input into clinical development planning and operational decision-making.