Clinical Trial Lead - sponsor-dedicated

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Job Overview

Clinical Trial Lead - sponsor-dedicated

Location: Munich, Germany / Home Office, 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 both the success of important clinical studies and meaningful professional development of your team members -, 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

• flexible working hours, capped overtime and compensatory time off in lieu
• 100% home-based, permanent employment contract
• travel time = work time
• highly competitive compensation packages including Christmas and vacation allowances
• regular, merit-based salary adjustments
• significant employer contribution to an attractive pension scheme
• excellent training and career development opportunites as well as support with furthering your education
• strong support from Line Management and more than 20’000 colleagues worldwide
• the world’s most renowned pharmaceutical companies as our satisfied, repeat customers for many years
  

As Clinical Trial Lead, 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, 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, including solid independent monitoring experience as sCRA or Lead CRA
• Professional 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
  Remote
  
  2021-60859
  
  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.