Study Start-Up Specialist
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 and leverage your know-how in the start-up phase of clinical trials - ensuring a successful start of important clinical studies -, this is the perfect opportunity. You will be working alongside a dedicated and supportive team of SSU experts and for world class pharmaceutical companies, 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!
Serve as the primary contact for investigative sites, proactively managing site activation and providing guidance for your sites during the start-up phase of your assigned studies
Ensure that all assigned maintenance and start-up activities are on track and in accordance with client expectations, ICH / GCP, SOPs, budget, quality and all applicable German laws and guidelines
Collect, track and perform a quality review of all essential and investigator documents required for effective and compliant study site activation and maintenance
Liaise with our regulatory department regarding document submission requirements and ensure documents required are collected and submitted on time. Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, taking ownership for compliance and audit readiness
Escalate any issues with submissions and / or approvals for your assigned studies appropriately and in a timely fashion, both to internal departments and to external stakeholders such as Institutional Review Boards (IRBs), Independent Ethics Committees (IECs) and German regulatory authorities
Customize country and site specific patient Informed Consent Forms to ensure compliance with local requirements and protocol
Support the negotiation of site contracts and budgets with study sites and track progress of contract and budget milestones / developments, intervening and escalating as appropriate
Degree in a relevant field such as pharmacology, life sciences, clinical trial management, (veterinarian) medicine, health care (management), nursing, chemistry, biology, oecotrophology etc.,
In lieu of the above, an equivalent completed vocational education or equivalent professional experience
Solid expertise in clinical trials within a CRO or a pharmaceutical company with a specialization in clinical study start up / regulatory processes
Demonstrated understanding of research protocol requirements as well as the ability to communicate them / educate others about them
Proven track record collaborating successfully with operational project teams as well as external investigative sites and German regulatory authorities (including IRBs and IECs)
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
Familiarity with investigator start-up documents and contract / budget negotiation processes with study sites
Autonomous work style with excellent time and project management skills
Business fluency in German and English - both spoken and written - is a must