Project Manager Study Start-Up, sponsor-dedicated
- Experience Level
- Experienced (non-manager)
Project Manager Study Start Up - sponsor-dedicated
Location: Munich, Germany
Labcorp Drug Development has supported the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. If you are looking to broaden your therapeutic expertise and sharpen your leadership skills, whilst having a true impact on the lives and health of people, this is the perfect opportunity. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers.
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 will:
- Execute and oversight the local operational clinical trial activities for assigned protocols in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements both internally and externally
- Own both country and site budgets, negotiate and complete Clinical Trial Research Agreements, oversee and track payments, reconcile payments at study close-out and maintain accurate data in our financial systems
- Execute and oversee country submissions and approvals
- Interact with IRB / IEC and the German regulatory authorities for assigned protocols
- Ensure quality and compliance in assigned protocols and contribute to the development of local materials and best practices
- Collaborate closely with Country Research Managers, Clinical Trial Coordinators, Clinical Research Associates, Finance, Legal and Regional Operations to ensure all country deliverables (e.g. submissions, budgets, Clinical Trial Research Agreements, local milestones) are met and aligned with country timelines
- 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
- Degree in a relevant field such as pharmacology, (veterinarian) medicine, oecotrophology etc., alternatively an equivalent scientific or commercial Higher Vocational education or relevant professional experience
- Profound clinical research experience, preferably as a clinical research associate (CRA) and / or in study start-up situations
- Solid experience with regulatory submissions in Germany - observing all local regulations, ICH and GCP
- 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 - are a must