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Senior Start Up Specialist

Employer
Labcorp
Location
Brussels, Belgium
Salary
Competitive
Start date
3 Oct 2019
Closing date
2 Nov 2019

View more

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

Job Details

Discover new opportunities to grow your career as a Covance FSP Start-Up Project Manager.



Are you someone with previous regulatory submissions experience looking for developing your career within this area?

At Covance we are recruiting for a Start-Up Associate Project Manager to work sponsor dedicated into a top 5 pharmaceutical company to be based in Belgium



At Covance, you can redefine what is possible and discover your extraordinary potential within ourFunctional Service Providerteam (FSP).



As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise.

Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance studies.

With the support of exceptional people and an energized purpose, you'll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.



Responsibilities:



FINANCIAL (as applicable):
  • Assistance with the ownership of country and site budgets.
  • Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
  • Oversight and tracking of clinical research-related payments
  • Payment reconciliation at study close-out.



COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS (as applicable):
  • Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
  • Development of local language materials including local language Informed Consents and translations.
  • Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.



MANAGEMENT & QUALITY OVERSIGHT:
  • Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments.
  • Contributes to the development of local SOPs.
Education/Qualifications:
  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
Experience:
  • Good organizational and time management skills
  • Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
  • Excellent communication skills, oral and written.
  • Self-motivation with the ability to work under pressure to meet deadlines
  • Works well independently as well as in team environment.
  • Detail and process oriented
  • Positive attitude and approach
  • Interact with internal and external customers with high degree of professionalism and discretion
  • Multi-tasking capability.
  • Good computer skills with good working knowledge of a range of computer packages
  • Ability to lead and develop junior staff
  • Flexible and adaptable to a developing work environment


Locations:
Brussels, Belgium

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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