Clinical Project Manager

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