Purpose

- Accountable for coordination of the operational management of assigned projects in order to develop compounds in line with Chiesi goals and medical/scientific standards.
- Accountable for communication to all stakeholders on the progress of the study
- Accountable to maintain and respect budget according to study signed contract

Main Responsibilities

• Typically manages 1-3 clinical trials, depending on size, complexity, phase of development and therapeutic area.
  • Responsible for management of the Clinical CRO/Providers
  • Acting as primary contact for Clinical (CRO) but also internal customers;
  • representing the Study Team for operational part of the clinical trials allocated to her/him.
  • Ensures adherence to scope of work within timelines and budget.
  • Reviews study related documents prepared by CRO (project plan, monitoring plan, risk management plan, site contracts when required,…). Performs co-monitoring when needed, as specified in SOP.
  • Collaborates in the set-up and maintenance of the Study Risk Register. Responsible clinical risk review involving all relevant study team functions and for the follow-up on actions with vendors (CRO, direct and third-party vendors).
  • Responsible for the management of the study eTMF (related to clinical operations) with the Clinical Trial Administrator (CTA).
  • Prepares and coordinates/collaborates to scientific meetings: investigators’ meeting, scientific/safety board meetings, Data reviews and any other relevant meeting(s).
  • Manages the preparation of experts/KOLs contract if any (when expert is dedicated to the study).
  • Study results and related deliverables:
    - Prepares & reviews he Clinical Study Report (CSR) in cooperation with the Medical Writer, and its approval.
    - Supports and/or coordinates the presentation of clinical study results internally and externally
• Clinical Trial Supplies:
  • liaises with Clinical Trial Supply (CTS) coordinator to define the CTS strategy/plan
  • Manages the CTS once delivered to sites
• Ensures that the trial complies to SOPs and all necessary quality standards. Responsible for corrective and preventive actions and follow-ups (e.g. in case of audits).
• Provides clinical operations input during study design, Clinical Protocol Approval Committee (CPAC), Extended Clinical Team Meetings
• Budget Management
  • prepares and presents budget in collaboration with Clin Ops Lead
  • accountable for budget management for the ongoing studies

Experience Required

At least 3 years of experience in a similar position in a pharmaceutical company or CRO.
Track record of achievements in successful planning and execution of at least 5 clinical studies.

Education

Degree in Life Sciences (biological science, pharmacy or other health related discipline) or equivalent.

Languages

Langues
English 5 or more (1 = beginner / 6 = fluent)

Technical Skills

Knowledge of principles of clinical study design
Knowledge of principles of Clinical Research Statistics
Knowledge of planning tools and planning principles
Knowledge of ICH/GCP and company SOPs
Knowledge of GLP for bio analytical assays (for Clinical pharmacology studies)
Familiar and up to date with relevant literature

Soft Skills