Are you a detail-oriented, proactive administrator with a passion for supporting clinical research? Join our dynamic Clinical R&D team as Clinical Study Administrator and play a vital role in the success of clinical trials. You will support both project managers and clinical study staff, ensuring the completeness, accuracy, and proper management of essential study documentation.
Key Responsibilities
* Clinical Study Administration (85%)
* Process, track, and file study documents according to regulations and departmental guidelines.
* Manage and maintain the Trial Master File (TMF) for assigned clinical studies.
* Build, upload, and track documents in clinical trial management systems ((one)CTMS and v-TMF).
* Create and distribute regulatory binders and wet-ink signed documents binders.
* Assist study staff and investigators in resolving issues related to study files and implementing corrective actions.
* Support communication of important clinical data and events within the team.
* Maintain tracking activities in (one)CTMS.
* Provide safety documentation to support safety committee meetings (supporting role).
* Support creation, ordering, and distribution of study supplies and devices when needed.
* Assist with logistics for investigator/expert panel meetings and newsletters.
* Participate in process improvement activities related to CTMS and TMF.
* Other Administrative Activities (15%)
* Provide general administrative support for clinical studies or department activities as assigned.
Requirements
Education
* Minimum of a Bachelor’s degree.
Experience
* At least 1 year of relevant administrative support experience is required.
* Clinical study administration or previous clinical research experience is a strong advantage.
* Clinical or medical background is a plus.
Skills & Competencies
* Strong experience with Microsoft Office tools (Excel, Word, PowerPoint).
* Excellent tracking, organizational, and documentation skills.
* High attention to detail.
* Effective written and verbal communication skills in English.
* Ability to work independently and proactively.
* Fluent in English (spoken and written); any other language is an advantage.
What can you expect?
* Company car and net expense allowance: You will receive a competitive salary package that includes a company car
* Opportunities for training and development: Arcadis offers a wide range of internal and external training opportunities to help you expand your expertise and advance your career.
* International network: Become part of a worldwide network of professionals and collaborate with colleagues and clients from across the globe.
* Innovation and sustainability: Contribute to innovative and sustainable projects that truly make a difference.
Choosing Arcadis means a dynamic work environment, interesting projects, and excellent opportunities for personal and professional growth!
Join Arcadis. Create a Legacy.