Associate Director, Clinical Data Standards & Governance

MSD

Argentina

On-site

ARS 217,624,000 - 342,483,000

Full time

5 days ago
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Job summary

Merck & Co., Inc. in Rahway, NJ, USA seeks an Associate Director, Data Collection Data Steward to oversee program-level data standards within GDMS/GCDS. Lead Therapeutic Area Standards Teams, train staff, and support information governance across the clinical lifecycle.

You will guide data definitions (EDC and non-EDC), ensure harmonization with CDISC and regulatory guidance, and mentor junior staff while partnering with cross-functional teams globally.

Qualifications

  • Associate’s degree and 15 years’ clinical data management or standards experience (or related discipline).
  • Bachelor’s Degree and minimum of 8 years’ clinical data management or standards experience.
  • Advanced Degree (Masters or Doctorate) and minimum of 4 years’ clinical data management or standards experience.

Responsibilities

  • Define and maintain standardized data collection definitions aligned with industry standards and regulations.
  • Participate and lead organizational initiatives as needed.
  • Support audits and inspections as required.
  • Develop and deliver standards training and best practices to cross-functional teams.
  • Mentor junior staff and engage in governance forums.

Skills

CDISC Standards
GCDS/GDMS
EDC Data Capture
GCP Compliance
Data Modeling
Regulatory Knowledge

Education

Associate’s degree
Bachelor’s degree
Advanced Degree

Tools

SDTM
CDASH

Job description

Merck & Co., Inc. in Rahway, NJ, USA seeks an Associate Director, Data Collection Data Steward to oversee program-level data standards within GDMS/GCDS. Lead Therapeutic Area Standards Teams, train staff, and support information governance across the clinical lifecycle.

You will guide data definitions (EDC and non-EDC), ensure harmonization with CDISC and regulatory guidance, and mentor junior staff while partnering with cross-functional teams globally.

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