Job DescriptionThis 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.
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.
Qualifications- 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.
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
The annual base salary for this position ranges from $205,000 to $230,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
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