Screening Manager


Summary:
The Screening Manager is responsible for overseeing the Screening. This position will ensure that the screening and panel review activity flow well together in an efficient and well-organized manner to maintain data integrity, and study participant safety.

Duties and Responsibilities:
Manages the Screening and Panel Review staff and that they communicate well together.
Conducts 1-on-1 with the screening and panel review staff on a weekly basis.
Oversees and/or Reviews Inclusion/Exclusion Criteria and Source Documents for all screening visits conducted.
Ensures that visits are done correctly, with minimal errors.
Oversees and/or performs audits to check for accuracy and completeness.
Conducts and documents staff training as needed.
Ensure that Site SOPs are being followed, and update and/or develop SOP's as necessary.
Review sources prior to randomization and verify that all subject eligibility criteria have been met.
Act as a resource for staff and provide support when necessary.
Implement processes that will minimize errors and risks on projects.
Track subject enrollment through randomization.
Obtain and review lab results prior to randomization.
Perform 100% quality control review of screening sources.
Create daily correction logs and follow up with staff for corrective action.
Maintain system of tracking errors and provide insight on how to increase efficiencies.
Must be pro-active in ensuring the quality control of subject data prior to the arrival of Sponsor/CRO monitoring visits by communicating and working with study teams.
Communicate information to Recruitment and Clinical Operations as subject eligibility is determined to ensure that study goals and timelines are met and adjustments are made accordingly.
Create and finalize screening summary sheets for all protocols.
Qualifications:
Management experience required.
Committed to ensuring customer service along with working independently and successfully managing multiple priorities simultaneously.
Clinical research experience minimum 3 years required.
Current BLS certification required.
Requires a thorough knowledge of the:
Clinical trial conduct
FDA regulations and ICH Guidelines
Demonstrated exceptional skills including, but not limited to:
Interpersonal, leadership and professional skills
Strong verbal and written communication skills
Drug development process
Clinical trial processes
Clinical monitoring
FDA regulations and ICH Guidelines
Requires a thorough knowledge of the:
Computer Programs, proficient in:
Microsoft Office (Excel, PowerPoint, Word and Publisher)
SharePoint
Preferred experience working in Clinical Operations for CRO or Pharmaceutical Company.

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