Associate Director, Clinical Data Management (Hybrid)

MSD•Rahway, PA

6d•Hybrid

About The Position

Global Clinical Data Standards Therapeutic Area Lead At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join our team and contribute to our mission of making a difference in global health. Responsibilities Define standard collection and mapping data definitions, ensuring alignment with industry (CDISC) standards and Health Authority regulations. Ensure the definitions are maintained and aligned across the clinical lifecycle (e.g., data collection, analysis & report, and submission) deliverables. Lead standards data governance reviews. Contribute to the definition and maintenance of business processes related to the definition, use, maintenance, and sharing of clinical data standards. Lead or participate in department initiatives, cross-functional working groups, and process improvement activities. Participate in cross-functional project teams; establish collaborations/interactions with colleagues outside the department and make frequent contacts external to the area and/or company. Maintain knowledge of new technologies, industry standards, regulatory requirements, and our company's guidelines and SOPs. Work independently or as a team member with equal effectiveness. Interact with staff across multiple company sites.

Requirements

B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.
8+ years’ work experience which includes 4 years of data management experience and a minimum 2 years in clinical data standards development; or advanced degree with 6+ years’ work experience of which 2 years need to be in clinical data standards development.
Advanced knowledge and leading-edge skills in clinical data standards.
Study Data Tabulation Model (SDTM) expertise.
InForm expertise.
Analysis & Reporting experience.
Program-level clinical and business requirements knowledge.
Strong communication and presentation skills.
Proficient in education, training, and facilitation.
Must have an innovative spirit, outstanding interpersonal skills, leadership, and demonstrated proficiency in the management of multiple projects.
Knowledge of clinical data management.
Accountability
Adaptability
Business Processes
Clinical Database Programming
Clinical Data Management
Clinical Data Standards
Data Analysis
Data Collection Methods
Data Governance
Data Quality Assurance
Data Reporting
Data Validation
Detail-Oriented
Electronic Data Capture (EDC)
Establishing Contacts
Global Health
Good Clinical Data Management Practice (GCDMP)
Good Clinical Practice (GCP)
Interpersonal Relationships
Leadership
Management Process
Mentoring Staff
Process Improvements
Project Management

Responsibilities

Define standard collection and mapping data definitions, ensuring alignment with industry (CDISC) standards and Health Authority regulations.
Ensure the definitions are maintained and aligned across the clinical lifecycle (e.g., data collection, analysis & report, and submission) deliverables.
Lead standards data governance reviews.
Contribute to the definition and maintenance of business processes related to the definition, use, maintenance, and sharing of clinical data standards.
Lead or participate in department initiatives, cross-functional working groups, and process improvement activities.
Participate in cross-functional project teams; establish collaborations/interactions with colleagues outside the department and make frequent contacts external to the area and/or company.
Maintain knowledge of new technologies, industry standards, regulatory requirements, and our company's guidelines and SOPs.
Work independently or as a team member with equal effectiveness.
Interact with staff across multiple company sites.