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The Opportunity
Description
We're looking for a Senior Clinical Study Associate, working in Pharmaceuticals and Medical Products industry in South San Francisco, California, 94080, United States.
- Mentoring of junior level Clinical StudyAssociates.
- Communicate with internal team members and Contract Research Organizations (CROs) regarding trial start-up, maintenance, and close-outactivities.
- In collaboration with the Clinical Study Manager (CSM), assists in the oversight of vendor activities along with theCRO.
- Oversight/support of some CRO activities.
- Receive regulatory documents for review and submission to the Regulatory Department.
- Develop Trial Master File (TMF) plan and manage through transfer of documents to the Sponsor
- Provide guidance with development of the clinical trial binders for study sites.
- Manage and track study-specific payments and invoices.
- Provide support for Investigator Meeting planning, including organizing meeting materials and provide on-site meeting assistance (as needed).
Our Client Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success - Bachelors degree or equivalent
- A minimum of 5 years in clinical research, or health related industry is required
- Highly effective verbal and written communication skills; effectively delivers key messages; aptitude to independently communicate with teams and stakeholders
- Demonstrates an aptitude to distill information from multiple sources to create meaningful insights and induces collaboration and innovative thinking study-wide
- Experience with effective vendor management preferred
What Do You Think? Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
