Ref #: 28244

Employment type: Permanent - Full-Time

Location: Home based anywhere in Germany

Posted: 07-Apr-2021

Description

Summary:

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 timo.kindermann@docsglobal.com or via our homepage www.ICONplc.com/FSP. We are looking forward to your application.
#CRA, #SSU