Clinical Trial Administrator - Germering, Germany in Germering bei Optimapharm d o o

Location: Company’s office in Germering

Who we are?

Optimapharm is a leading, mid-sized, full-service CRO working across Europe and North America to deliver new therapies to improve and save patients’ lives. Optimapharm’s key priorities are our people and consistently exceeding our client’s expectations.

With 27 strategically located offices, Optimapharm operates in 40+ countries, giving unrivaled access to Patients and Investigators in all countries in Europe and North America.

OPTIMAPHARM acquired SSS CRO, a highly reputable full-service CRO from Germany, and since then, significantly strengthened its presence in the DACH region.

In-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years.

We are looking for a CTA to join our Clinical Operations team in Germany and support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.

What do we offer?

• Working in a successful company that’s growing and changing every day
• Working with a highly experienced team of the clinical research professionals
• International projects and professional growth
• Performance bonus
• Training opportunities
• Work from home
• Flexible work hours

Who are we looking for?

Qualifications and Experience

• University degree (bacc.), High School Diploma or an equivalent combination of education, training & experience
• At least 1-2 years of administrative support experience as a CTA
• Computer proficiency is mandatory (strong knowledge of Outlook, Microsoft Word, Excel and PowerPoint)
• Fluent in local language and English; both, written and verbal
• Strong organizational skills and strong attention to detail, with the ability to manage multiple tasks effectively
• Understanding clinical trials, and relevant regulations, including ICH GCP
• Strong negotiation skills and proactivity

Your responsibilities

• Supporting the Clinical Project Managers and Clinical Research Associates in the trial feasibility process, start-up, and initiation, monitoring, and close-out activities.
• Supporting the Clinical Project Managers and Clinical Research Associates with set up and maintenance of trial-related files.
• Assisting with the preparation of submission dossiers to Ethics/Regulatory/local Institutional Boards, as needed; preparation of back-up files of submission dossiers (electronically and/or hard copy), as needed.
• Assisting in the tracking of the project-specific data regarding trial progress, including Ethics/Regulatory, if needed, patient recruitment, site information, monitoring visits, safety reporting, trial supplies, data collection, trial documentation, payments, and other trial-related tasks. Development of appropriate tracking tools.
• Ensuring that submissions and approvals are filed in the project files (paper and/or electronic, as applicable)
• Ensuring the content of the project files (paper and/or electronic) is ICH GCP compliant and that these files are compliant with applicable SOPs
• Upload and/or send documentation to the Trial Master File (TMF) or eTMF
• Follow up on queries from the Sponsor regarding eTMF/TMF
• Co-ordination of delivery for trial supplies and trial documents with the sites

By joining our fast-growing and prosperous team, you will have a great opportunity for further personal growth and career development.

If you would be interested in joining the Optimapharm team, please send your CV in English and note that only shortlisted candidates that meet the requirements will be contacted for the further selection process.