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Clinical Project Leader

Employer
Labcorp
Location
Belgium
Salary
Competitive
Start date
27 Nov 2020
Closing date
4 Dec 2020

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


The Clinical Project Leader (CPL) is responsible for the set up and progress of a clinical trial/study within the allocated countries, ensuring compliance with company quality standards and regulations in force, the forecasted timelines, milestones and budget.

The CPL represents the countries in his/her perimeter at the global Clinical Trial Team (CTT) and is the main contact for the Regional Trial Manager (RTM) and global CTOM.

He/she ensures liaison with other CTT members (CSD, SDM, TSOM...).

He/she leads the monitoring teams in the designated countries for his/her trials

He/she represents the CSU at Medical Affairs/Business Unit meetings to feed back on study progress

KEY RESULTS/ACCOUNTABILITIES:

n Is 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), and that committed targets and timelines are met at all steps and until study completion (recruitment, active/inactive sites, deadlines for DMCs, DBL, closure of sites, archiving).

n Is the first point of contact for Regional Trial Managers (RTM), other global CTT members and the local monitoring teams.

n Is the 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

n Organizes kick-off meeting with local monitoring teams (MT).

n Organizes training of monitoring teams (study procedures, study devices, monitoring plan,...).

n Organizes investigators meetings.

n Provides support to MT (protocol, monitoring plan, CRF, tools...)

n Prepares or arranges the preparation of protocols, written subject information, other essential documents, CSR, etc. for studies initiated locally

n Ensures the preparation of local study AED within/across the countries, ensures optimization of costs, and manages the country study budget

n Ensures the implementation of study IT systems in the countries (IVRS, ePortal)

n Ensures adequate provisioning of devices and materials in the countries enough in advance

n Participates in the revision/preparation of study progress tools (newsletters,...)

n Ensures CTMS are updated appropriately (e.g. IMPACT, ClubNet, PRISMA etc.)

n Sources and manages service providers for studies initiated locally (e.g. Medical Writer, Statistician, Data Manager, Central Laboratory, CRO, etc.)

n Oversees field monitoring activities through regular contacts with local MT (e.g. local CTT meeting), review of MVRs, checks on monitoring tool compliance.

n Identifies potential problems (risks) and ensures issues are solved with action plans in place (recruitment, study conduct/data quality,...).

n Ensures high quality level in data collection and queries resolution for the countries.

n Conducts appropriate accompanied site visits

n Ensures preparation and proper response to audit/inspection reports and implementation of recommendations.

n Shares lessons learned and ensures adequate deployment of possible identified action plans for improvement within/across the countries.
Education/Qualifications:
  • Educated to degree level in a science or medical speciality. A post graduate qualification is highly desirable.
  • Knowledge of clinical trial design and development in relevant therapeutic areas.
  • Thorough working knowledge of all aspects of GCP and the regulatory/ethical framework pertaining to clinical trials; Ability to plan, set and manage clinical trial budgets.
  • Ability to learn and apply SOPs .
  • Good IT skills in, e.g. MS Office, are essential, for planning, tracking, communicating and reporting.
  • Management, leadership, negotiation skills and communication skills, organizational, analytical and planning abilities, results oriented, quality preserving, be proactive and able to anticipate and resolve conflicts/issues, reactivity to emergent needs, able to prioritize, time management
  • Fluent in English, French and Dutch
Experience:
A minimum of 5 years of professional experience in Clinical Development (e.g. as CRA) and a minumum of 1 year in a CPL/CTL posiiton or simmilar.

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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