Sr. Study Site Specialist

The Sr. Study Site Specialist will be responsible for conducting end-to-end site management from feasibility to site activation serving as the primary point of contact for the site and the study team. This includes supporting site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, and all study and site start-up, maintenance and close-out activities.

• Assist in development of in-house model process documents.
• Serve as an In-House Study Lead, a primary point of contact to study team on end-to-end study activity.
• Lead In-House Study team meetings as appropriate.
• Participate in In-House Study Management meetings.
• Utilize tools to track activities and develop reports.
• Oversee Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires.
• Oversee site contract/budget negotiations (Confidentiality Agreements, Clinical Trial Agreements and Ancillary Agreements).
• Oversee essential document collection, tracking & review.
• Support the collection of country and site level intelligence.
• Support Ethics Committee and Regulatory Authority submissions.
• Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a study as appropriate.
• Assist in the development of In-House study processes and procedures.

• Minimum of five years of relevant experience in the biopharmaceutical/CRO industry.
• Flexibility to assume a workload, which frequently necessitates an adjustment of priorities.
• Goal oriented, self-starter with proven ability to work independently.
• Able to proactively identify issues and provide potential solutions for resolution.
• Detail oriented.
• Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
• Proficiency with Veeva Vault and all applications of Microsoft Office.
• Good interpersonal skills.
• Comfort with ambiguity; ability to act without having the total picture.
• Read, write and speak fluent English

   

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