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Clinical Operations Study Country Lead (Coscl)

0-2 years
$100,500.00 - $145,166.66
10 Sept. 12, 2025
Job Description
Job Type: Hybrid Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Clinical Operations Study Country Lead (COSCL)

Location

  • Cambridge, Massachusetts

  • Morristown, New Jersey

  • Remote, Oregon / US Remote

Salary Range

USD 100,500 – 145,166.66


About the Job

Are you ready to shape the future of medicine?
The race is on to accelerate drug discovery and development to deliver answers for patients and their families.

We are seeking a highly motivated and experienced Clinical Operations Study Country Lead (COSCL) to support US clinical trial operations. This role is pivotal in ensuring the success of country-level clinical trial execution while driving innovation through AI-enabled solutions.


Job Purpose

The COSCL is a strategic leader within the Clinical Study Unit (CSU), accountable for the planning, execution, and oversight of clinical trials in the US. This includes managing all stages of the study — from country allocation through study closure and archiving — while ensuring compliance with:

  • Sanofi SOPs

  • ICH/GCP guidelines

  • Local regulatory requirements


Key Responsibilities

  • Strategic Leadership

    • Represent the US at global study meetings as the primary interface between CSU and global study teams (COSL).

    • Escalate risks and make country-level decisions to ensure successful study delivery.

  • Study Operations

    • Oversee all trial activities from allocation to archiving.

    • Ensure compliance with international and local regulations.

    • Drive operational efficiency by leveraging AI-driven solutions and digital technologies.

  • Collaboration & Stakeholder Management

    • Partner closely with internal cross-functional teams and external stakeholders.

    • Support business continuity and process optimization.

    • Actively contribute to accelerating clinical trial execution in the US.


Ideal Candidate Profile

  • Strong background in clinical operations and trial management.

  • Proven expertise in ICH/GCP and regulatory requirements.

  • Deep understanding of digital technologies and AI applications.

  • Demonstrated success in implementing innovative trial solutions.

  • Effective communicator with leadership experience in cross-functional/global teams.