Senior 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
• Ideal candidate will be located in Eastern Time Zone

Main Responsibilities

• Making appropriate operational decisions to ensure that clinical trials are initiated and completed on time, on budget and to the required quality standards, securing compliance ICH and Chiesi SOPs.
• Providing clinical operations input to Clinical Program Leader and study team members during study design, Protocol Review Committee and critical steps of the study conduct.
• Study documents:
  • Developing full protocol from the Study Outline contained in the CDP, involving all relevant contributors/accountable persons (Clinical Research Physician, Clinical Pharmacologist, statisticians, Cl.Ph.Vig. Health Economics consultant, data manager, CTS coordinator etc.)
  • Managing e-doc process for relevant study documents. Register the study in clinical trial.gov. Responsible for preparation of study documents for e-submissions
  • Collaborates with relevant contributors and accountable team members to ensure timely production and review of study-related documentation (IMPD, Insurance certificate, EUDRACT form, CRF, Statistical Analysis Plan, Data Management Plan, CSR etc.), and giving his/her professional support to the planning and organisation of investigator meeting and/or scientific/safety board meetings, Data Safety Reviews, Blind reviews and any other study-relevant meeting.
• Clinical Trial Supplies: Liaising with CTS coordinator to assess needs for drug supply, completion of the CTS request form, place orders with relevant departments in due time, and agree with CTS primary & secondary packaging, use of IVRS, shipment to depot or to investigational site(s), management of study drugs labels / study drug leaflets. If applicable he/she might delegate to CTA.
• Obtaining, evaluating and coordinating required input from all internal departments/specialists to ensure clinical trials comply with SOPs and all necessary standards, as detailed below. Giving input in the Chiesi system to track study audits.
• Study Budget Studies to start within a year:
  • Prepares in collaboration with LSHM and Outsourcing Manager the budget to be validated during the PRC.
  • Prepares in collaboration with LSHM forecast for studies that are planned within the year but have not reached the stage of PRC at the time of forecast/pre-closing.
• Ongoing Studies:
  • Responsible of reconciling original budget with actual charged ensuring that invoices received are checked and correspond to actual expenses done (approved or challenge them until approved). Twice a year provides forecast & budget revision according to study progress (March/April & August/September)
  • CRO and/or Providers selection: contributing to their selection by completing the RFP and review the proposals/contracts as per the Chiesi guideline/SOP in place.
  • Acting as primary contact for internal or external (CRO) customers, for operational part of the clinical trials allocated to them. Managing day-today relationships, raising issues as soon as they are identified.
  • Is accountable for the clinical study archiving as per Chiesi SOP.
  • Typically manages 1-3 clinical trials at any one time, depending on size, complexity and phase of development, ideally focused on a single multiple therapy area.
  • When applicable responsible of presenting clinical study results internally and externally (i.e. scientific conferences)
• For Clinical pharmacology studies:
  • Acting as the scientific lead person for development and validation of bioanalytical methods as well as routine study sample analysis. Responsible for managing projects ensuring compliance with GLP practices.

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.
• 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)

Education

Degree in Life Sciences or equivalent.