Director, Data Management
At a glance
Director-level Data Architecture & Governance role at Alkermes. Waltham · full-time · $205,000–$230,000 base.
dataroles summary, based on the employer's posting.
What you'll do
- Set data management plans across clinical programs and oversee deliverables for studies run internally or by CROs
- Guide vendors using performance measures, quality checks, timelines, issue tracking and governance reviews
- Oversee trial database design, testing and upkeep, plus study data cleaning approaches and quality goals
- Keep study records inspection-ready and set standards for eCRFs, CDASH, terminology and CDISC outputs
- Lead staff development and departmental work on SOPs, data standards, systems, automation and process improvement
What you bring
- A relevant bachelor's degree in life sciences, health sciences, computer science, clinical research or a related area
- At least ten years in pharmaceutical or biotech data management, including three or more years leading or supervising
- Hands-on leadership of end-to-end clinical data management across multiple studies, with lead data manager experience
- Strong GCP and ICH knowledge, including 21 CFR Part 11 requirements
Who this fits
This director role suits an experienced clinical data manager who has led teams and managed data across multiple studies, including global trials. You will directly manage staff and work with cross-functional and geographically distributed teams. The role requires at least three days a week on site in Waltham and is not fully remote.
From the employer
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.
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.
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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