Associate Director, Clinical Data Management

Job Description

The 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.

Responsibilities

• Define 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).

• Participate and lead organization initiatives as needed.

• Support audits and inspections as required.

• Support 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.

• Develop and deliver Standards training and best-practices to cross-functional teams.

• Participate in training development, training delivery, and mentoring to members of the Global Clinical Data Standards team.

• Engage 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.

• Act 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.

• Provide 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.

• Work 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.

• Support 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.

• Participate 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.

• Support 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.

Technical skills

• Expertise in clinical data standards development and implementation.

• Deep 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]).

• Deep understanding of and experience with clinical development trial processes, including data management and worldwide regulatory DM (Data Management) & reporting requirements.

• Demonstrated understanding of program-level clinical and business requirements and impact of standards

• Strong knowledge of the Drug Discovery Process, ICH (International Council for Harmonization) and GCP (Good Clinical Practice) guidelines.

• Demonstrated knowledge in at least 1 TA with ability to drive consistency across all studies in a clinical development program and/or therapeutic area

• Knowledge of Analysis & Reporting.

• Expertise in electronic Data Capture and external supplier data

• Ability 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.

• Ability 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.

Preferred:

• Direct 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).

• Experience 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.

• Ability to leverage technical solutions to manage functional and/or project deliverables and associated quality with assigned projects.

Non-technical knowledge, skills, and abilities

• Strong communication and collaboration across cross-functional and global teams; crafts concise, decision-ready summaries for leadership, clearly framing risks, options, and recommendations.

• Strong organization and prioritization, managing multiple deliverables, planning across tasks, running risk/change control, aligning stakeholders (including vendors), and providing reliable status and governance updates.

• Ability to lead through influence, motivating cross-functional and geographically diverse teams, guiding and reviewing work, and fostering an inclusive, high-trust culture.

• Sound 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).

• Leadership presence and people development, mentoring and coaching team members, representing the team professionally in internal and external/vendor forums, and maintaining resilience under pressure.

• Continuous improvement mindset, proactively identifying ways to improve quality, efficiency, and transparency in ways of working, tools, and governance.

• Ability to drive adoption of standardized ways of working, engaging cross-functional partners to support consistent use.

Enterprise Leadership Skills

• Influence: Involve others in exploring solutionsAsk for otherss ideas and build on them to reach a mutually agreeable solution; seek and respect alternative approaches and conflicting viewpoints to identify points of agreement.

• Business Savviness: AnalyzeUse organization and industry information to identify trends, assess current business practices and results, and/or evaluate specific function/operation changes and anticipate their impact.

• Networking and Partnerships: Seek opportunities to build relationshipsProactively build effective working relationships with those who have the knowledge, experience, resources or influence to advance work goals.

Qualifications & experience

• Associates degree and a minimum of 15 years clinical data management or standards experience (or related discipline)

OR

• Bachelors Degree and minimum of 8 years clinical data management or standards experience

OR

• Advanced Degree (Masters or Doctorate) and minimum of 4 years clinical data management or standards experience

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Secondary Language(s) Job Description

Directeur(trice) associe9(e) Gestion des donne9es cliniques

Le directeur associe9 ou la directrice associe9e, responsable de la gouvernance des donne9es de collecte, GDMS GCDS, assure la supervision des normes de donne9es le2ge des programmes, guide les quipes de9tude dans le2utilisation des bibliothe8ques et la gouvernance de premie8re ligne, et fait progresser les normes nouvelles ou modifie9es ainsi que les processus ope9rationnels. La personne dirige les quipes responsables des normes par domaine the9rapeutique (TAST) et les activite9s de formation, soutient la gouvernance de le2information, assure le suivi de la conformite9 et des avantages obtenus, et encadre le personnel moins expe9rimente9.

Responsabilite9s

• De9finir et tenir jour les de9finitions normalise9es de collecte de donne9es, tant pour la saisie lectronique des donne9es (EDC [Electronic Data Capture]) que pour les autres modalite9s, en conformite9 avec les normes de le2industrie (p. ex., CDISC [Clinical Data Interchange Standards Consortium]) ainsi que2avec la re9glementation et les lignes directrices des autorite9s de sante9; assurer leur harmonisation tout au long du cycle de vie clinique (collecte, analyse et production de rapports, et soumission re9glementaire).
• Participer aux initiatives organisationnelles et les diriger, au besoin.
• Soutenir les audits et les inspections, au besoin.
• Soutenir les examens de gouvernance de le2information qui lui sont confie9s (p. ex., triage, valuation des re9percussions, curation et re9troaction des parties prenantes/ame9lioration continue) par le2interme9diaire des quipes de gouvernance TAST (Therapeutic Area Standards Teams, quipes responsables des normes par domaine the9rapeutique) et SLIC (Shared Clinical Data Standards Council, conseil des normes communes de donne9es cliniques).
• Participer le2laboration et la prestation de formations ainsi que2au mentorat des membres de le2quipe mondiale des normes de donne9es cliniques.
• Participer aux forums de le2industrie, entretenir un re9seau de contacts et influencer le2orientation strate9gique de le2industrie ainsi que le2laboration des normes de donne9es cliniques. Repe9rer les tendances lie9es aux avance9es technologiques, le2volution des normes de le2industrie et aux exigences re9glementaires, et de9terminer leurs re9percussions sur la mise en uvre des normes de notre enterpsie.
• Agir comme partenaire fiable aupre8s de GDMS et des autres quipes interfonctionnelles en sollicitant activement leurs commentaires, en harmonisant les priorite9s et en assurant le suivi de la re9troaction afin de favoriser une exe9cution coordonne9e et de grande qualite9.
• Assurer la supervision et fournir une expertise au personnel, dans un ou plusieurs domaines the9rapeutiques (TA [Therapeutic Areas]), en matie8re de conception de la collecte et de la transformation des donne9es ainsi que de mode9lisation des donne9es, en veillant au respect des lignes directrices tablies en matie8r