Study Start-Up Associate - Clinical Trials

Location: Munich, 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 entry level 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 Study Start-Up Associate, you typically will:

• Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance
• Ensure that all assigned maintenance and start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines
• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements.
• May support / assist the contract negotiation process under supervision of an experienced colleague or line manager
• Escalate study issues appropriately and in a timely fashion
• Update study documents when there are changes in study personnel/study amendments
• Contribute to the preparation of submissions to IRB/IEC with appropriate supervision
• Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time
• Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision
• Perform other duties as assigned by management

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:

• First professional experience in clinical trials within a CRO or a pharmaceutical company, preferably with a specialization in clinical study start up / regulatory processes
• Basic understanding of research protocol requirements
• Working knowledge of ICH, IRB/IEC and other applicable regulations and guidelines
• Collaborative work style with strong time and project management skills
• Business fluency in German and English - both spoken and written - is a must

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