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Clinical Project Support Specialist
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Job Purpose: The Clinical Project Support Specialist plays a vital role in ensuring the smooth execution of phase I-IV clinical trials on a global level. This individual will provide comprehensive operational support to the global study team, optimizing study efficiency, compliance, and quality, and 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, such as study guides, instructions, and newsletters, to support various roles within the study.
- Establish and manage multiple Study Contact Lists, including Study/Clinical Team, Vendor/External Suppliers, and Study Organizations in Veeva.
- Update study Q&A and Action Log, as well as oversee the QSD tracker to ensure timely availability of required documents.
- Set up and maintain project and study platforms/software, such as SharePoint and Teams, and support Clinical/Study Team members with ad-hoc tasks.
- Support audits and inspections according to company policy and SOPs, and assist with EU-CTR transition and study submissions.
- Act as a Study Team key contact with eTMF Specialist/System Specialist and support the organization of Clinical/Study Team and Steering Committee meetings.
- Maintain different study trackers to ensure study oversight and quality at various levels, including vendor trackers and logistics.
- Create study-specific reports and update team study trackers that cannot be pulled from existing systems.
What You'll Need: To succeed in this role, you will require strong organizational and communication skills, with the ability to work effectively in a global team environment and manage multiple tasks and deadlines. You will also need to be proficient in relevant software and systems, and have a solid understanding of clinical trial operations and regulatory requirements.
