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Clinical Project Manager
Il y a 4 mois
**Date**: Mar 15, 2024
**Department**: Global Clinical Development
**Job Type**: Direct Employee
**Team**: R&D, Pharmacovigilance & Regulatory Affairs
**Contract Type**: Permanent
**Location**:
Paris, Bois Colombes, FR
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
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