Under the guidance of Clinical Study Support (CSS) management, this position will be responsible for performing site and site study personnel evaluations as needed for Global Clinical Studies (i.e. contracts, sponsor statements and insurance). Responsibilities include supporting CSS Central Services team as needed.
Summary Of The Essential Functions Of The Job
- Perform Pre-Study Visit (PSV) evaluations in accordance with SOPs and Work Instructions.
- Perform Site Study Staff qualifications checks including but not limited to Debarment, Disqualification, Quality Flag and Site Audit Checks.
- Liaise with systems personnel to create appropriate reports as needed.
- Maintain data in an identified system.
- Assist in the reporting of Key Performance Indicators and Central Services metrics.
- Maintains consistent communications with internal clients, including in-person discussion, telephone calls, and email.
- Bachelors Degree
- Minimum of three years of relevant experience in the biopharmaceutical/CRO industry.
- Experience with conflict resolution.
- Proven ability to effectively manage change.
- Ability to negotiate complex contract and payment terms.
- Flexibility to assume a workload which frequently necessitates an adjustment of priorities.
- Goal oriented, self-starter with proven ability to work independently.
- 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 all applications of Microsoft Office.
- Good interpersonal skills.
- Comfort with ambiguity; ability to act without having the total picture.
