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Our client is a leading research-based biopharmaceutical company. They apply science and their global resources to deliver innovative therapies that extend and significantly improve lives. Every day, colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
ROLE SUMMARY
The Clinical Study Team Sr. Associate Role is an essential part of our client’s Study Team and is responsible for driving and/or supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and their SOPs. The role collaborates with global study team members and is responsible for multiple tasks that span from study start-up to study close-out which enables the efficient execution of clinical trials to high quality standards.
ROLE RESPONSIBILITIES
- Trial Master File (TMF) maintenance, compliance, and oversight
- Maintain their registries and systems as required to ensure compliance
- Liaising with cross functional study team members:
- Provide support with audit and inspection readiness activities
- Perform customization of ICDs and other site documents and coordinate the translation of documents as required
- Provide status updates and support on key tasks and activities and contribute to the Study Team Meetings as an active Study Team member.
- Provide support to CSTA managers for development and implementation of on-boarding training for new hires:
- Mentor new hires and entry level CSTAs
- Serve as Subject Matter Expert for key CSTA processes, systems and tasks. Work with CSTA managers to identify continuous improvement opportunities to enhance operational efficiencies.
BASIC QUALIFICATIONS
- 3+ years experience with BA/BS or 1+ years experience with MA/MBA/MS
- Proficient in Microsoft Office applications (Outlook, Word, PowerPoint, Excel, TEAMS)
- Relevant clinical research or clinical trial experience
- Strong understanding of the scope of clinical trial administration
- Proficient level of English
