Covance

Senior Study Start-Up Specialist - Clinical Trials

Company
Covance
Location
Munich, Germany
Salary
Competitive
Posted
14 May 2021
Closes
12 Jun 2021
Ref
10024_64447
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

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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