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Clinical Project Leader - FSP -

Employer
Labcorp
Location
Israel (IL)
Salary
TBD
Start date
27 Aug 2019
Closing date
26 Sep 2019

View more

Discipline
Clinical Research, Clinical Project Manager
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

 

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

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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