Clinical Project Administrator

at  EastHORN Clinical Services

Founded in 1997, Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase. Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award 2023, the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2023, the Asia-Pacific Contract Research Organization Company of the Year Award since 2006. The Company offers a comprehensive suite of services including laboratories, Phase I facilities, drug development consulting, regulatory expertise, and has experience with over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech is a trusted end-to-end strategic partner of choice.
Our international clients value our enthusiastic, flexible and quality-focused professional approach to meeting their needs, and we are continuing to grow further. To support our future development, we are currently looking for a Clinical Project Administrator.

JOB SUMMARY:

As a Clinical Project Administrator you will be expected to provide clerical support to project team during the study conduct, assist in regulatory submission and Clinical Research Associate activities at the study start and perform other administrative duties as assigned by management.
Reporting to the Senior Clinical Operations Manager, you will be an important member of the Clinical Operations team in Germany.
We are searching for an ambitious and energetic person, able to undertake challenges in the projects.
We ensure detailed training in the job responsibilities and on the job support and mentoring as well as possibility for further development and career advancement in our growing company.

REQUIRED QUALIFICATIONS, EXPERIENCE, COMPETENCIES

• Excellent written and oral communication skills in English and German
• Excellent organizational and time management skills
• Flexibility, adjustability, initiativeness
• Persistence in study and development
• Openness to learn new things and communicate across countries and cultures
• Attention to detail
• Ability to work well within a team
• Computer competency
• Degree in life sciences or related allied health profession (e.g. nursing certification, medical or laboratory technology)
• Previous experience in clinical research field will be additional advantage.

• Providing clerical support to project team (e.g., word processing, proofreading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, etc.)
• Assisting in submission and other Clinical Research Associate activities e.g. compiling of regulatory packages, translation of clinical documents, updating trackers, assisting in feasibility
• Setting up and maintaining clinical investigator files and documentation in-house and on-site
• Preparing investigator budget payments and tracking systems; generating tracking reports as assigned
• Performing data entry and maintenance of selected study tracking databases
• Preparing monitoring visit documentation for Clinical Research Associate
• Preparing study-related documents and other materials for delivery to archives, at appropriate intervals