Area Clinical Operations Lead

Purpose

•    Responsible to ensure the connection between the high level expertise within different studies and the wider view of the program. Early, late phase and RWE components need to be connected and to become functional part of a bigger picture. Late phase global study coordination, early phase study management and interaction with Health Authorities represent key assets for the position.
•    Accountable for coordination of the operational management of assigned projects in order to develop compounds in line with Chiesi goals and medical/scientific standards. 
•    Be the referent point for the other functions in CDP (having the Clinical Project Managers as subject matter expert of the different studies) overseeing the entire value chain of Clinical Operations within the program (switch from activities to continuity in the development). 
•    Accountable to maintain and respect program budget 
•    Line management of Clinical Project Managers 

Main Responsibilities

- To ensure the connection between the high level expertise within single study conduction to the wider view of the program. Early, late phase and RWE components need to be connected and to become functional part of a bigger picture.

- To supervise and oversee the entire value chain of Clinical Operations within the assigned program 
- To ensure that GANTT master on the clinical operations activities within an assigned program is set up 
- Late phase global study coordination, early phase study management and interaction with Health Authorities experience represent key assets for the position
- To be the referent point for the other functions in CDP (having the Clinical Project Managers as subject matter expert of the different studies). Contributes to the Clinical Development Plan (CDP) definition in relation to the studies’ operational aspects and geographic feasibilities (including costs and timelines input on the CDP)
- To supervise and ensure that the CRO and/or Providers selection for Clinical Studies is fit for purpose for the overall project development requirements 
- Participates in the preparation of the documentation for eCTD submissions 
- Provides strategic and operational input/support to the CPM during study design, Clinical Protocol Approval Committee preparation 
- Contribute as CDP team member to the preparation of the update following committee:
 o    CPRF (Clinical Project Review Forum) update; 
 o    PRM (Project Review Committee meeting)
 o    XRC or other according to Company need
- Involved in the writing/review of SOPs and working instructions (WI). 
- Performs Line Management of Clinical Project Managers
- Project Management:
 o    Supervises the development of full synopsis and protocol according to Study Outline contained in the CDP and of any other important study-related documentation

 o    Ensures that the CPMs develop the  timelines/GANTT chart on the clinical operations activities within an assigned study  
 o    Supports the CPMs in the selection process for the CRO and/or other service providers
 o    Acts as escalating contact for CRO and/or other service provider. 
 o    Prepares in collaboration with the Head of Clinical Project Management Unit the forecasting for future studies 
 o    Supervise the study budget prepared by CPM to be validated during the CPAC. Shares the budget proposed with the with the Head of Clinical Project Management Unit
 o    Supervises variations of the study budgets compared to forecast & preclosing. Twice a year, reviews the forecast & preclosing budgets prepared by the CPMs according to study progress
    

Experience Required

• As a plus, experiences abroad in particular in US
• At least 8 years of experience in a Clinical Research Project Management in a pharmaceutical company or CRO.
• Track record of achievements in successful planning and execution of at least 10 clinical studies.
• A previous managerial experience in a global context of at least 5 years is recommended. 
• Plus are represented by 8 years experience in pharmaceutical company at Corporate Level and management of interaction with Health Authorities (HA), in collaboration with Regulatory Affairs for submission strategies and early interactions with FDA and European authorities; 
• Preferred location is US, but there is flexibility in evaluating other possible locations based on candidate’s needs

Education

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

Languages

English fluent

Technical Skills

• Knowledge of principle of clinical drug development from early stages to post approval setting
• 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
   

Soft Skills