Executive Lead, Clinical Data Standards & Governance

Merck; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck in Rahway, NJ seeks an Associate Director, Data Collection Data Steward to provide program-level oversight of data standards within Global Data Management and Standards. You will guide study teams on library use and governance while advancing new and modified standards and business processes.

You will lead Therapeutic Area Standards Teams, deliver training, support information governance, and mentor junior staff, influencing industry directions and ensuring high-quality, compliant data

Qualifications

• 15+ years of clinical data management or standards experience for the TA/leadership role.
• Strong knowledge of CDISC standards and regulatory guidance (CDASH, SDTM, Define.xml).
• Experience with electronic data capture and data transformation to SDTM.
• Ability to lead cross-functional teams and mentor staff.
• Excellent communication and governance skills.

Responsibilities

• Define and maintain standard data collection definitions aligned with industry standards and regulations across the clinical lifecycle.
• Lead organization initiatives and participate in governance teams.
• Support audits and inspections as required.
• Deliver Standards training to cross-functional teams and mentor staff.
• Engage in industry forums to influence standards development.

Skills

Data standards

CDISC/CDASH/SDTM

GCDMP/GCP

Data governance

Mentoring/leadership

Data modeling

EDC knowledge

Education

Associate’s degree and 15+ years of clinical data management or standards experience

Bachelor’s degree in a related field

Advanced degree (Master’s/PhD) in a related field

Job description

Merck in Rahway, NJ seeks an Associate Director, Data Collection Data Steward to provide program-level oversight of data standards within Global Data Management and Standards. You will guide study teams on library use and governance while advancing new and modified standards and business processes.

You will lead Therapeutic Area Standards Teams, deliver training, support information governance, and mentor junior staff, influencing industry directions and ensuring high-quality, compliant data