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.
ResponsibilitiesProvide 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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About Us
Why join Team Alkermes?
Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
Skills Required
- Bachelor's degree in Life Sciences, Health Sciences, Computer Science, Clinical Research, or a related discipline
- At least 10 years of data management experience in a pharmaceutical or biotechnology setting
- At least 3 years of supervisory or leadership experience
- Significant experience as a Lead Data Manager or equivalent with end-to-end clinical data management responsibility across multiple studies
- Experience managing global clinical trials and geographically distributed cross-functional teams
- Advanced knowledge of GCP and ICH standards
- Knowledge of 21 CFR Part 11
- CCDM certification
- Strong leadership, interpersonal, organizational, and multitasking skills
What We Do
Alkermes focuses on the development of innovative medicines that seek to address unmet needs of people living with serious mental illness, addiction, and cancer. As a fully-integrated, global biopharmaceutical company, we apply our scientific expertise and proprietary technologies to develop products that are designed to make a meaningful difference in the way patients manage their disease. We are inspired by some of the most pressing public health challenges of our time to help advance innovation with the potential to improve treatment options and outcomes for patients. Beyond our important mission of developing medicines, we believe it is our responsibility to take a holistic approach as we seek to support patients, caregivers, and broader impacted communities. In this context we also work to help support and enhance the systems through which these complex diseases are treated. We are committed to patient engagement, disease education and awareness, and advocacy for important policies that support equitable access to quality treatment. Headquartered in Dublin, Ireland, we have an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. See our Community Guidelines: https://www.alkermes.com/social-community-guidelines
