Senior Study Start-Up Specialist - Clinical Trials

Location: Munich, Germany / Home Office, 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 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!

As Senior Study Start-Up Specialist, you typically will:

• Provide expertise for local regulations, ICH/GCP and relevant study and sponsor requirements
• When delegated by Start-up Country Manager (SUCM), oversee and ensure quality data and audit readiness
• Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required
• Ensure efficient in country execution and local improvements aligned with global requirements
• Review and approve projections and timelines to study teams, ensuring that they accurately represent the country's performance and suggests mitigation actions in agreement with SUCM
• Develop project specific plans for the Site Activation component of assigned studies
• When appropriate, take a lead in team meetings to resolve issues and progress the trial
• Review and approve Country and Site Specific patient informed consents for compliance to local requirements and protocol with agreement by SUCM
• Proactively resolve informed consent and contractual language issues plus other significant barriers to study execution with study sites
• Oversee start up activities (possibly across a range of studies) to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual
• Liaise with Covance regulatory regarding document submission requirements
• Ensure appropriate systems are updated accurately and compliantly, with site information and study dates (projected and actual) ensuring others follow established processes
• Coach other start-up team members
• May take country start up lead role for larger/more complex projects
• May have line management responsibilities for a small number of staff, including performance management, career development, regular one to one's salary and promo recommendations

Education/Qualifications:

• 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

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

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