Sr. Clinical Project Manager

This is what you will do

• 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 

You’ll be responsible for:

• 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 them.
• 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 

You will need to have

• At least 3 years of experience in a similar position in a pharmaceutical company.
• Fluent in English
• Track record of achievements in successful planning and execution of at least 5 clinical studies.
• Degree in Life Sciences (biological science, pharmacy or other health related discipline) or equivalent.
• 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

Location

Hybrid role based in Cary, NC. #LI-Hybrid