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Project Manager Study Start-Up, sponsor-dedicated

Employer
Labcorp
Location
Munich, Germany
Salary
Competitive
Start date
13 Jun 2021
Closing date
14 Jun 2021

View more

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

Job Details


Project Manager Study Start-Up, sponsor-dedicated
Location: Munich, Germany

Covance by Labcorp has supported the pharmaceutical industry in developing more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers.
If you are looking to take on responsibility, hone your leadership skills and leverage your extensive know-how in clinical trials - ensuring a successful start of important clinical studies -, this is the perfect opportunity. You will be working directly with one of our renowned key sponsors, in a role that allows you to have a real impact on people's health and lives.

What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.
Sounds exciting? Then we would love to hear from you!

As Project Manager Study Start-Up, you typically will:
  • Execute and oversee the local clinical trial activities for assigned protocols in compliance with ICH/GCP and German regulations, client policies and procedures, quality standards and adverse event reporting requirements
  • Own both country and site budgets, negotiate and close Clinical Trial Research Agreements, oversee and track payments, reconcile payments at study close-out and ensure accurate data in our financial systems
  • Manage and coordinate local processes such as clinical and ancillary supplies management, im- and exporting requirements, supplies destruction, local electronic / hard copy filing, archiving and retention requirements, insurance process management and data quality
  • Execute and oversee country submissions and approvals
  • Collaborate with Institutional Review Boards (IRBs), Independent Ethics Committees (IECs) and other regulatory authorities
  • Contribute to the development of local materials and best practices
  • Collaborate closely with other internal and sponsor departments to ensure all country deliverables are met and aligned with timelines
Education/Qualifications:
  • Degree in a relevant field such as pharmacology, life sciences, clinical trial management, (veterinarian) medicine, health care, nursing, chemistry, biology, oecotrophology etc.
  • In lieu of the above, an equivalent completed vocational education or equivalent professional experience
Experience:
  • Deep expertise in clinical trials within a CRO or a pharmaceutical company, either including independent monitoring experience or a specialization in clinical study start up processes
  • In-depth experience with submissions to the German regulatory authorities - observing all local regulations and guidelines as well as international standards such as ICH and GCP
  • Leadership skills demonstrated by coaching, mentoring and coordinating teams locally and/or virtually
  • Leadership experience in a comparable position (e.g. Clinical Trial Lead, Clinical Research Manager, Study Start-Up Lead, Clinical Safety / Quality Manager etc.) a definite plus
  • Autonomous work style with excellent time and project management skills
  • Ability to build trustful, sustainable relationships with a wide variety of stakeholders based on your outstanding listening and communication skills
  • Business fluency in German and English - both spoken and written - is a must


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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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