Director, Clinical Data Management Medical Coding

2 weeks ago

Massachusetts, United States SoTalent Full time

Director, Clinical Data Management – Medical Coding


Remote (U.S. – based in Massachusetts)


Estimated Salary: $130,000 – $156,000 per year

About the Role

We're seeking an experienced Director of Clinical Data Management with a focus on medical coding to lead the strategic design and execution of global coding operations across clinical programs. This leadership role oversees internal teams and vendor partners to ensure timely, compliant, and high-quality coding deliverables in alignment with regulatory standards and best practices.

Key Responsibilities

  • Define and implement a long-term medical coding strategy, including resource planning, vendor partnerships, and technology adoption.
  • Oversee global coding operations across programs, ensuring compliance with ICH-GCP, regulatory requirements, and internal quality standards.
  • Serve as the subject matter expert for medical coding, collaborating with data management, pharmacovigilance, and medical teams to ensure consistency and accuracy.
  • Partner with cross-functional and technology leaders to optimize systems that support efficient dictionary management and coding oversight.
  • Lead the development and implementation of global coding conventions to drive standardization across therapeutic areas.
  • Manage vendor performance, ensuring quality deliverables, adherence to metrics, and continuous process improvement.
  • Support regulatory submissions through timely and accurate coded data delivery.
  • Recruit, mentor, and develop a high-performing medical coding team.
  • Provide strategic input on cross-functional initiatives, operational improvements, and data governance.

Qualifications

  • Bachelor's or Master's degree in life sciences, health sciences, or a related technical field (RN or RPh preferred).
  • 10+ years of clinical data management and medical coding experience within the pharmaceutical or biotechnology industry.
  • 7+ years managing vendor relationships and partnerships.
  • 5+ years of people management experience.
  • Deep knowledge of GCP, ICH, and FDA regulations as they apply to clinical data management and coding.
  • Expert proficiency with MedDRA and WHO Drug dictionaries.
  • Hands-on experience with clinical data management systems such as Oracle Clinical, TMS, Medidata RAVE, or InForm.
  • Proven ability to lead large-scale coding operations for global development programs.
  • Strong cross-functional communication and stakeholder management skills.
  • Experience with budget management and strategic resource planning.

Ideal Candidate

You're a collaborative leader with strategic vision and operational expertise in clinical data management. You bring deep technical knowledge of coding standards and systems, a passion for innovation, and the ability to align global teams toward a unified data strategy.

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