Associate Director, Clinical Data Management (Rahway, New Jersey)

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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 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.

• Business 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.

• Networking 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.

Qualifications & experience

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

OR

• Bachelor's 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

#GDMS 

clinicaltrialjobs

eligibleforERP

Required Skills:

Adaptability, 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:

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Secondary Language(s) Job Description

Directeur(trice) associé(e) Gestion des données cliniques

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