Associate Director, Clinical Data Management (Hybrid)

Merck • North Wales, PA

7d • 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.

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.

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.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees