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Clinical Operations Manager

Il y a 3 mois

BoisColombes, Île-de-France Chiesi Group Temps plein
Objective

Responsible for overseeing the operational management of designated projects to advance compounds in alignment with Chiesi's objectives and medical/scientific standards.
- Ensures effective communication with all stakeholders regarding study progress.
- Maintains and adheres to budgetary constraints as per the signed contract.

Key Responsibilities
  • Manages 1-3 clinical trials, varying by size, complexity, phase of development, and therapeutic area.
    • Oversees the management of Clinical CRO/Providers.
    • Acts as the primary liaison for Clinical (CRO) and internal stakeholders.
    • Represents the Study Team concerning the operational aspects of assigned clinical trials.
    • Ensures compliance with the scope of work within established timelines and budget.
    • Reviews study-related documents prepared by CRO, including project plans and monitoring plans, and performs co-monitoring as necessary.
    • Collaborates in the establishment and maintenance of the Study Risk Register, conducting clinical risk reviews with relevant study team functions and following up on actions with vendors.
    • Manages the study eTMF related to clinical operations in conjunction with the Clinical Trial Administrator (CTA).
    • Prepares and coordinates scientific meetings, including investigators' meetings and safety board meetings.
    • Handles the preparation of contracts for experts/KOLs when applicable.
    • Oversees study results and deliverables:
      - Prepares and reviews the Clinical Study Report (CSR) in collaboration with the Medical Writer and secures its approval.
      - Supports and/or coordinates the presentation of clinical study results both internally and externally.
  • Clinical Trial Supplies:
    • Coordinates with the Clinical Trial Supply (CTS) coordinator to define the CTS strategy/plan.
    • Manages the CTS post-delivery to sites.
  • Ensures compliance with SOPs and quality standards throughout the trial, including corrective and preventive actions as necessary.
  • Provides clinical operations insights during study design and Clinical Protocol Approval Committee (CPAC) meetings.
  • Budget Management:
    • Prepares and presents the budget in collaboration with the Clinical Operations Lead.
    • Accountable for ongoing budget management for studies.
Required Experience

A minimum of 3 years in a similar role within a pharmaceutical company or CRO.
A proven track record of successful planning and execution of at least 5 clinical studies.

Educational Background

A degree in Life Sciences (biological sciences, pharmacy, or a related health discipline) or equivalent.

Language Proficiency

Languages:
English proficiency level 5 or higher (1 = beginner / 6 = fluent).

Technical Expertise

Familiarity with clinical study design principles.
Understanding of Clinical Research Statistics.
Proficient in planning tools and methodologies.
Knowledge of ICH/GCP and company SOPs.
Awareness of GLP for bioanalytical assays (for Clinical pharmacology studies).
Up-to-date with relevant literature.

Interpersonal Skills