Study Site Specialist
Study Site Specialist
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Job Description
Job Summary
This position will be responsible for participating in endtoend site management from feasibility to site closure serving as a point of contact for investigative sites and the study team members. This includes supporting site qualification site level regulatory green light and site maintenance/closeouts.
Duties and Responsibilities
- Participate in development of inhouse model process documents.
- For assigned sites and countries serve as a primary site contact for endtoend study activity.
- Participate in all assigned Study Site Management study team meetings providing crossfunctional teams with detailed updates related to study and site activity.
- Utilize systems and tools to track assigned activities and produce reports and metrics as needed.
- 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 sitespecific activities (e.g. compiling submitting and obtaining import/export licenses radiation board and biobank committee approvals etc. required to activate or maintain sites for a study as appropriate.
Qualifications (Minimal acceptable level of education work experience and competency)
- Bachelors Degree in Business Administration Finance science or related field or work experience equivalent.
- Minimum of five years of relevant experience in the biopharmaceutical/CRO industry.
- Ability to negotiate complex contract and payment terms.
- Flexibility to assume a workload which frequently necessitates an adjustment of priorities.
- Goal oriented selfstarter 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.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at .
At IQVIA we believe that diversity inclusion and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone everywhere. When our talented employees bring their authentic selves and their diverse experiences to work they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multitalented collaboration harnesses innovation to deliver superior outcomes.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
