Project Manager Study Start-Up, sponsor-dedicated

☞ Labcorp Drug Development

Vue: 184

Jour de mise à jour: 24-10-2024

Localisation: Munich Bavaria

Catégorie: Planification / Projets IT - Logiciel

Industrie: Staffing Recruiting Biotechnology Pharmaceuticals

Niveau: Entry level

Type d’emploi: Full-time

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le contenu du travail

Job Overview

Project Manager Study Start-Up, sponsor-dedicated

Location: Munich, Germany

Labcorp Drug Development 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
2021-61539

Covance is proud to be an Equal Opportunity Employer:

 As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant’s race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
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Date limite: 08-12-2024

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