Clinical Project Support Specialist
hace 4 semanas
Key Role Details
The Clinical Project Support Specialist plays a pivotal role in ensuring the smooth execution of phase I-IV clinical trials by providing administrative, logistical, and operational support on a global level.
This role is designed to optimize study efficiency, compliance, and quality, contributing to the timely regulatory submissions and market approval of new medicines and medical devices.
Key Responsibilities
- Create and maintain different study documents and tools to support various roles within the study.
- Update study Q&A and Action log.
- Oversight of QSD tracker to ensure timely availability of QSD lists.
- Set up and maintain project and study platforms/software.
- Support Clinical/Study Team members with ad hoc tasks.
- Support audits and inspections according to company policy and SOPs.
- EU-CTR transition support and study submissions.
- Meeting support and communication.
- Operating trackers/reports.
- System management.
- Vendor/CRO handling.
Requirements
- Bachelor's degree or equivalent in a relevant field with 1 year + of experience in clinical research/development ideally in the pharmaceutical industry.
- Experience working with VEEVA System is a plus.
- Ability to manage multiple high-level parallel tasks, work unsupervised, and have effective computer skills.
- Excellent knowledge of Microsoft Office programs and strong prioritization skills.
- Flexibility, willingness to support the team, and ability to manage complexity.
- Excellent planning and organizational skills, innovativeness, and keen attention to detail.
- Strong interpersonal, communication, and team working skills.
- Fluency in English (both written and oral) with additional language skills a plus.
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