Ref #: 28244

Employment type: Permanent - Full-Time

Location: Home based anywhere in Germany

Posted: 07-Apr-2021



If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in Biotechnology, then here is your chance. To strengthen our internal SSU Team, DOCS is hiring a Study Start-Up CRA (m/f) to work closely with one of the most successful international biotech companies.

Key responsibilities:

• Work independently on EC and local authority submissions in Germany
• Manage document amendments and corrections as requested by the authorities
• Provide input into feasibility, identify clinical investigators and conduct site evaluations post-feasibility to determine site suitability and selection
• Conduct occasional site visits as necessary for SSU purposes
• Responsible for study start-up activities, including creating site folders, collating, preparing and maintaining (e)SIP documents and updating systems in collaboration with the CTA-Team
• Ensure collection, review, track and provision of appropriate clinical documents to support regulatory submission and to perform IRB/IEC submissions including preparation and submission of all documents to the central and/or local committee

Education & Experience

• BSc. or MSc. degree in life sciences or equivalent
• Several years of experience working as CRA and/or as SSU (working on industry-sponsored or industry-partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company)
• Strong experience within study start-up, especially in EC trial submissions phases 1,2,3 and NIS with a track record of having managed submissions independently from start to finish
• Attention to detail, organizational skills, time management & prioritization
• Proficiency in English and German
• Good working knowledge of common software packages

What is offered:

• Home-office with occasional travel
• Great work environment
• Interesting trials in various therapeutic areas
• Possibility to gain solid experience in a global pharmaceutical company
• Unlimited employment contract with DOCS
• Compensatory time-off
• Contribution to pension scheme

Why this vacancy is right for you:

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Would you like to know more? Please submit your CV to or via our homepage We are looking forward to your application.