{"id":3198651,"url":"https://alion.io/job/alkermes-director-data-management","title":"Director, Data Management","company":{"id":1780712,"name":"Alkermes","domain":"alkermes.com","url":"https://alion.io/company/alkermes","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":75,"open_postings":8,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Leadership","role_family":"Leadership","seniority":"head","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Waltham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":205000,"max":230000,"currency":"USD","period":"year","gross":null,"usd_annual":230000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"CDISC","optional":false},{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"SAS","optional":false}],"status":"live","first_seen_at":"2026-08-20T18:56:33Z","employer_posted_date":"2026-08-20","last_verified_at":"2026-10-25T10:44:47Z","board_verified":true,"closed_at":null,"days_open":65,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":65},"description":"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.\nThe 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.\n Provide strategic and operational leadership for Clinical Data Management activities across all clinical development programs.\n\nPlan, coordinate, and oversee all Data Management deliverables for internally managed clinical studies.\n\nProvide sponsor oversight for CRO-managed studies and ensure effective governance of external Data Management vendors.\n\nEstablish and monitor vendor performance through defined KPIs, quality metrics, timelines, issue management, and governance meetings.\n\nOversee the design, build, validation, testing, deployment, and maintenance of clinical trial databases in compliance with ICH-GCP, applicable regulatory requirements, and company standards.\n\nDevelop study-level Data Management strategies, including data collection approaches, risk-based data cleaning methodologies, and database quality objectives.\n\nEnsure inspection readiness of all Data Management Trial Master File (TMF) documentation and deliverables.\n\nEstablish, implement, and maintain standards for eCRF design, CDASH implementation, controlled terminology, data collection conventions, and CDISC-compliant data outputs.\n\nProvide 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.\n\nCollaborate 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.\n\nDevelop, monitor, analyze, and communicate departmental performance metrics and quality indicators to support continuous improvement.\n\nLead departmental initiatives related to SOP development, inspection readiness, data standards, system implementation, process optimization, automation, data integration, and clinical data governance.\n\nEvaluate and implement innovative technologies and industry best practices to improve Data Management efficiency and quality.\n\nContribute to Risk-Based Quality Management (RBQM) strategies and centralized monitoring initiatives, as applicable.\n\nRecruit, mentor, coach, and develop Data Management staff while fostering a culture of accountability, collaboration, and continuous learning.\n\nProvide direct people management, including performance management, goal setting, succession planning, career development, resource planning, and organizational growth.\n\nRepresent Data Management on cross-functional governance committees and provide strategic input into clinical development planning and operational decision-making.\n\n Bachelor's degree in Life Sciences, Health Sciences, Computer Science, Clinical Research, or a related discipline required.\n\nMinimum 10 years data management (atleast 3 years of supervisory/leadership) experience in a pharmaceutical/biotech setting, CCDM preferred.\n\nSignificant experience serving as a Lead Data Manager or equivalent, with direct responsibility for end-to-end clinical data management activities across multiple clinical studies.\n\nExperience managing global clinical trials and working with cross-functional and geographically distributed teams.\n\nAdvanced knowledge of GCP/ICH standards, 21 CFR Part 11.\n\nStrong leadership skills and ability to work within cross-functional teams.\n\nExcellent interpersonal, organizational, and multi-tasking skills.\n\nAlkermes 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.\nThe 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","description_format":"text","description_chars":5080,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Continuous learning","Hybrid work"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Biologics & Biosimilars","Psychiatric Care"],"lifecycle":[{"event":"open","at":"2026-10-24T06:46:48Z"}],"visa":[],"liveness":{"score":19,"band":"cold","label":"Long shot","p_open":1,"p_active":0.665,"p_room":0.28,"age_days":65,"expected_fill_days":22,"reasons":["conf:8","win:tail","crowd:"],"computed_at":"2026-10-25T05:49:26Z"},"pay":{"stated_usd_annual":230000,"is_top_pay":false},"html_url":"https://alion.io/job/alkermes-director-data-management","json_url":"https://alion.io/job/alkermes-director-data-management.json","meta":{"generated_at":"2026-10-25T18:55:34Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":26864,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1780712},"rest":"https://alion.io/mcp/rest/get_company?id=1780712"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Falkermes-director-data-management"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Falkermes-director-data-management"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Falkermes-director-data-management"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/alkermes-director-data-management\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Falkermes-director-data-management"}]}