{"id":3180737,"url":"https://alion.io/job/merck-co-associate-director-clinical-data-management","title":"Associate Director, Clinical Data Management","company":{"id":3768,"name":"Merck & Co.","domain":"msd.com","url":"https://alion.io/company/msd","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":100,"open_postings":123,"ghost_share":0.008,"stale_share":0.122,"repost_share":0.089,"time_to_fill_p50_days":15,"computed_at":"2026-10-27T05:46:45Z"}},"role":"Field & Service","role_family":"Field & Service","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Rahway, United States","Argentina","Canada","Colombia","Poland","Costa Rica"],"countries":["US","AR","CA","CO","PL","CR"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":142400,"max":224100,"currency":"USD","period":"year","gross":null,"usd_annual":224100},"salary_estimate":null,"experience_years_min":15,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"CDISC","optional":false},{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"HL7","optional":false}],"status":"live","first_seen_at":"2026-10-23T21:25:32Z","employer_posted_date":"2026-10-23","last_verified_at":"2026-10-27T06:11:33Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Job Description\nThe Associate Director, Data Collection Data Steward, Global Data Management and Standards (GDMS), Global Clinical Data Standards (GCDS) provides program-level oversight of data standards, guiding study teams on library use and first-line governance while advancing new/modified standards and business processes. Lead Therapeutic Area Standards Teams (TASTs), training, support information governance, track conformance/benefits, and mentor junior staff.\nResponsibilities\nDefine and maintain standard data collection (EDC [Electronic Data Capture] and non-EDC modalities) definitions aligned with industry standards (e.g., CDISC [Clinical Data Interchange Standards Consortium]) and Health Authority regulations and guidance; ensure harmonization across the clinical lifecycle (collection, analysis and reporting, and submission).\nParticipate and lead organization initiatives as needed.\nSupport audits and inspections as required.\nSupport assigned information governance reviews (e.g., triage, impact assessment, curation, and stakeholder feedback/continuous improvement) via TAST (Therapeutic Area Standards Teams) and the SLIC (Shared Clinical Data Standards Council) governance teams.\nDevelop and deliver Standards training and best-practices to cross-functional teams.\nParticipate in training development, training delivery, and mentoring to members of the Global Clinical Data Standards team.\nEngage in industry forums, maintaining network of contacts, and influence industry strategic direction and clinical data standards development. Identify trends in developments of technologies, evolution in industry standards and regulatory requirements, and identify implications on our company's standards implementations.\nAct as a reliable partner to GDMS and other cross-functional teams, actively seeking input, aligning on priorities, and closing feedback loops to drive high-quality, coordinated delivery.\nProvide oversight and expertise within one or multiple TAs (Therapeutic Areas) on data collection/data transformation design and data modeling to all staff, assuring consistency with established standards guidelines.\nWork as a sitting member of the core design team for assigned studies and provide first line governance support for changes to existing library forms and new content. \nSupport the development of future standards libraries (including in new therapeutic areas) and reviews of existing processes within SOPs (Standard Operating Procedures), WIs (Work Instructions), etc., ensuring they are in-line with quality requirements.\nParticipate in assigned operational and study team forums ensuring clinical data standards align with industry standards, our company's standards and processes, and information management best practices.\nSupport the definition and maintenance of the data collection Functional Area business processes and supporting technologies related to the definition, maintenance, application, and sharing of clinical data standards.\nTechnical skills\nExpertise in clinical data standards development and implementation.\nDeep knowledge of and experience with applying CDISC Clinical Study Data standards (e.g., CDASH [Clinical Data Acquisition Standards Harmonization], Controlled Terminology, SDTM [Study Data Tabulation Model]).\nDeep understanding of and experience with clinical development trial processes, including data management and worldwide regulatory DM (Data Management) & reporting requirements.\nDemonstrated understanding of program-level clinical and business requirements and impact of standards\nStrong knowledge of the Drug Discovery Process, ICH (International Council for Harmonization) and GCP (Good Clinical Practice) guidelines.\nDemonstrated knowledge in at least 1 TA with ability to drive consistency across all studies in a clinical development program and/or therapeutic area\nKnowledge of Analysis & Reporting.\nExpertise in electronic Data Capture and external supplier data\nAbility to take an enterprise-wide view of study needs that is inclusive of Controlled Terminology, SDTM, analysis and reporting, and submission targets and deliverables to ensure appropriate application of standards.\nAbility to interpret the study protocol as it relates to study design. Ability to interpret protocol requirements to facilitate cross-functional understanding of data types and sources which are then translated into high quality, compliant data standard definitions.\nPreferred:\nDirect experience implementing industry standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM [Analysis Data Model], & HL7 [Health Level Seven International]) and requirements for analysis & reporting and submission deliverables (e.g., SDRG [Study Data Reviewer's Guide], ADRG [Analysis Data Reviewer's Guide], Define.xml).\nExperience managing clinical data management processes including electronic eCRF (electronic Case Report Form) design, clinical database development and validation, user acceptance testing, external data management and knowledge of data transformation to SDTM, and analysis & reporting.\nAbility to leverage technical solutions to manage functional and/or project deliverables and associated quality with assigned projects.\nNon-technical knowledge, skills, and abilities\nStrong communication and collaboration across cross-functional and global teams; crafts concise, decision-ready summaries for leadership, clearly framing risks, options, and recommendations.\nStrong organization and prioritization, managing multiple deliverables, planning across tasks, running risk/change control, aligning stakeholders (including vendors), and providing reliable status and governance updates.\nAbility to lead through influence, motivating cross-functional and geographically diverse teams, guiding and reviewing work, and fostering an inclusive, high-trust culture.\nSound judgment and accountability, operating effectively in ambiguity, managing escalations, and contributing to consensus on process and technology improvements (including RCA [Root Cause Analysis]/ CAPA [Corrective and Preventive Action] where applicable).\nLeadership presence and people development, mentoring and coaching team members, representing the team professionally in internal and external/vendor forums, and maintaining resilience under pressure.\nContinuous improvement mindset, proactively identifying ways to improve quality, efficiency, and transparency in ways of working, tools, and governance.\nAbility to drive adoption of standardized ways of working, engaging cross-functional partners to support consistent use.\nEnterprise Leadership Skills\nInfluence: Involve others in exploring solutions-Ask for others’ ideas and build on them to reach a mutually agreeable solution; seek and respect alternative approaches and conflicting viewpoints to identify points of agreement.\nBusiness Savviness: Analyze-Use organization and industry information to identify trends, assess current business practices and results, and/or evaluate specific function/operation changes and anticipate their impact.\nNetworking and Partnerships: Seek opportunities to build relationships-Proactively build effective working relationships with those who have the knowledge, experience, resources or influence to advance work goals.\nQualifications & experience\n Associate’s degree and a minimum of 15 years’ clinical data management or standards experience (or related discipline)\nOR\nBachelor’s Degree and minimum of 8 years’ clinical data management or standards experience\nOR\n Advanced Degree (Masters or Doctorate) and minimum of 4 years’ clinical data management or standards experience\n#GDMS\nclinicaltrialjobs\neligibleforERP\nRequired Skills:\nAdaptability, Adaptability, Building Capability, Clinical Database Programming, Clinical Data Management, Clinical Data Standards, Coaching, Competency Management, Compliance Activities, Data Analysis, Data Management, Data Quality Assurance, Data Reporting, Data Validation, Detail-Oriented, Enterprise Leadership, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Implement Training Programs, Interpersonal Relationships, Mentoring Staff, Operational Quality, Prioritization, Process Improvements, Process Standardization {+ 9 more}Preferred Skills:\nCurrent Employees apply HERE\nCurrent Contingent Workers apply HERE\nSecondary Language(s) Job Description\nDirecteur(trice) associé(e) Gestion des données cliniques\nLe directeur associé ou la directrice associée, responsable de la gouvernance des données de collecte, GDMS GCDS, assure la supervision des normes de données à l’échelle des programmes, guide les équipes d’étude dans l’utilisation des bibliothèques et la gouvernance de première ligne, et fait progresser les normes nouvelles ou modifiées ainsi que les processus opérationnels. La personne dirige les équipes responsables des normes par domaine thérapeutique (TAST) et les activités de formation, soutient la gouvernance de l’information, assure le suivi de la conformité et des avantages obtenus, et encadre le personnel moins expérimenté.\nResponsabilités\nDéfinir et tenir à jour les définitions normalisées de collecte de données, tant pour la saisie électronique des données (EDC [Electronic Data Capture]) que pour les autres modalités, en conformité avec les normes de l’industrie (p. ex., CDISC [Clinical Data Interchange Standards Consortium]) ainsi qu’avec la réglementation et les lignes directrices des autorités de santé; assurer leur harmonisation tout au long du cycle de vie clinique (collecte, analyse et production de rapports, et soumission réglementaire).\nParticiper aux initiatives organisationnelles et les diriger, au besoin.\nSoutenir les audits et les inspections, au besoin.\nSoutenir les examens de gouvernance de l’information qui lui sont confiés (p. ex., triage, évaluation des répercussions, curation et rétroaction des parties prenantes/amélioration continue) par l’intermédiaire des équipes de gouvernance TAST (Therapeutic Area Standards Teams, équipes responsables des normes par domaine thérapeutique) et SLIC (Shared Clinical Data Standards Council, conseil des normes communes de données cliniques).\nÉlaborer et offrir aux équipes interfonctionnelles des formations sur les normes et les pratiques exemplaires.\nParticiper à l’élaboration et à la prestation de formations ainsi qu’au mentorat des membres de l’équipe mondiale des normes de données cliniques.\nParticiper aux forums de l’industrie, entretenir un réseau de contacts et influencer l’orientation stratégique de l’industrie ainsi que l’élaboration des normes de données cliniques. Repérer les tendances liées aux avancées technologiques, à l’évolution des normes de l’industrie et aux exigences réglementaires, et déterminer leurs répercussions sur la mise en œuvre des normes de notre enterpsie.\nAgir comme partenaire fiable auprès de GDMS et des autres équipes interfonctionnelles en sollicitant activement leurs commentaires, en harmonisant les priorités et en assurant le suivi de la rétroaction afin de favoriser une exécution coordonnée et de grande qualité.\nAssurer la supervision et fournir une expertise au personnel, dans un ou plusieurs domaines thérapeutiques (TA [Therapeutic Areas]), en matière de conception de la collecte et de la transformation des données ainsi que de modélisation des données, en veillant au respect des lignes directrices établies en matière de normes.\nSiéger à l’équipe principale de conception des études qui lui sont confiées et fournir un soutien de première ligne en matière de gouvernance pour les modifications aux formulaires existants des bibliothèques et l’ajout de nouveau contenu.\nSoutenir l’élaboration de futures bibliothèques de normes, y compris dans de nouveaux domaines thérapeutiques, ainsi que l’examen des processus existants décrits dans les procédures opératoires normalisées (SOP [Standard Operating Procedures]), les instructions de travail (WI [Work Instructions]), etc., en veillant à leur conformité aux exigences de q...","description_format":"text","description_chars":23630,"description_truncated":true,"requirements":{"experience_years_min":15,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":false},"security_clearance":false,"languages":[]},"benefits":["Flexible schedule"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"},{"name":"Puerto Rico","iso":"PR","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","Veterinary Medicine","Vaccines","Biologics & Biosimilars"],"lifecycle":[{"event":"open","at":"2026-10-23T21:25:32Z"}],"visa":[],"liveness":{"score":81,"band":"hot","label":"Hiring now","p_open":0.9,"p_active":0.903,"p_room":1,"age_days":3,"expected_fill_days":15,"reasons":["conf:57","velocity","win:early","comp:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":{"stated_usd_annual":224100,"is_top_pay":true},"html_url":"https://alion.io/job/merck-co-associate-director-clinical-data-management","json_url":"https://alion.io/job/merck-co-associate-director-clinical-data-management.json","meta":{"generated_at":"2026-10-27T09:44:21Z","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":11030,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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":3768},"rest":"https://alion.io/mcp/rest/get_company?id=3768"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmerck-co-associate-director-clinical-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%2Fmerck-co-associate-director-clinical-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%2Fmerck-co-associate-director-clinical-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/merck-co-associate-director-clinical-data-management\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmerck-co-associate-director-clinical-data-management"}]}