Covance

Clinical Project Leader - FSP -

Company
Covance
Location
Israel (IL)
Salary
TBD
Posted
27 Aug 2019
Closes
26 Sep 2019
Ref
35033
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

 

Covance is currently recruiting a Clinical Project Leader to join the teams of one of our main client, a well-known international and innovative pharmaceutical company with offices in Israel. 

 

 

 

The Clinical Project Leader (CPL) represents the countries in his/her perimeter and leads the monitoring teams in the designated countries for his/her trials.  

 

 

 

Responsibilities:

 

 

 

  • Accountable for set-up activities according to the company standards, regulations in
    force and country generic administrative timelines (submission to ECs/IRBs/HAs,
    approvals, contracts with sites, local AEDs)
  • Committed to have targets and timelines met at all steps and until study completion 
  • First point of contact for Regional Trial Managers (RTM), other global team
    members and the local monitoring teams
  • First point of contact for Medical Affairs/Business Units for locally initiated studies,
    providing input to feasibility, study design and budget development and providing
    feedback on study progress
  • Organizes kick-off meeting with local monitoring teams
  • Organizes training of monitoring teams (study procedures, study devices, monitoring
    plans...)
  • Organizes investigators meetings.
  • Provides support to the monitoring team (protocol, monitoring plan, CRF, tools…)
  • Prepares or arranges the preparation of protocols, written subject information, other
    essential documents, CSR, etc. for studies initiated locally
  • Ensures the implementation of study IT systems in the countries (IVRS, ePortal)
  • Participates in the revision/preparation of study progress tools (newsletters,…)
  • Ensures CTMS are updated appropriately
  • Sources and manages service providers for studies initiated locally (e.g. Medical
    Writer, Statistician, Data Manager, Central Laboratory, CRO, etc.)
  • Oversees field monitoring activities through regular contacts with local Monitoring teams (e.g; review of MVRs, checks on monitoring tool compliance)
  • Identifies risks and ensures issues are solved with proper action plans 
  • Ensures high quality level in data collection and queries resolution at a local level
  • Conducts appropriate accompanied site visits
  • Ensures preparation and proper response to audit/inspection reports and
    implementation of recommendations