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READING CENTER PROJECT MGR.
Job Title: READING CENTER PROJECT MGR.
Job Code: 0809
Job Level: 10
Revised Date: 04/01/2020
Job Family: JF 05
Project Manager Assistant (PMA) Duties
Interact with clinical study sites regarding image materials issues Assist with study startup, site certification activities Serve as backup liaison between the Duke Reading Center and the study sites Serve as backup liaison with study sponsor and CRO as appropriate Assist with data transfers to the study sponsor Attend conference calls with study sponsors Perform routine correspondence with sites, sponsors, and CROs Confirm receipt of all image materials received at the Duke Reading Center Respond to data queries as appropriate Prepare materials for grading and arbitration Perform data entry, filing, and other clerical duties Assist all Duke Reading Center staff members as necessary to meet the needs of the various studies Attend Duke Reading Center group meetings as needed
Level I Project Manager Duties
Interact with clinical study sites regarding image materials issues Initiate and facilitate study startup, site certification activities Serve as liaison between the Duke Reading Center and the study sites Serve as liaison with study sponsor and CRO as appropriate Maintain appropriate documentation for all related image materials received at the Duke Reading Center Assign study images to appropriate readers Notify clinical study sites of identifying information discrepancies and resolve these discrepancies Respond to data queries and questions from study sites, sponsors and CROs as needed Prepare materials for data checking and materials checking programs Assign OCT scan for QA cycles, on direction from QA/QC coordinator Coordinate data transfers to the study sponsor Conduct conference calls with study sponsors as needed Ensure that all data received and handled meet applicable HIPAA standards Train study coordinators and site technicians in their appropriate responsibilities Maintain an inventory and obtain duplicate scans for internal use and teaching presentations Attend Duke Reading Center group meetings as needed Attend study sponsor Investigator meetings as needed Manage studies without eligibilities Manage relatively small studies (typically less than 50 projected patients or less than 20 sites) Manage studies with one or two imaging modalities Draft work instructions for review by PM Level III Manage a study that has already met enrollment if eligibilities were required. This would be a study that is transitioned from a higher level PM to a PM 1, and could be a small, medium, or large study. Manage studies with no more than one Director of Grading Manage studies with no contractor involvement, unless the subcontractor is doing certification only.
Level II Project Manager Duties
Manage studies with eligibility and re-treatment evaluations for SDOCT, FAF, FA and FP FP and other imaging and functional testing modalities Process Eligibility and Re-Treatment Evaluations with a 48 hr turnaround Manage studies with multiple imaging/functional testing modalities Write work instructions Manage PMA and work study students Manage studies with more than one Directors of Grading (typically at least two) Manage studies with subcontractor involvement Train PMA and PM 1
Required Qualifications at this Level
Work requires analytical, communications, and organizational skills generally acquired through completion of a bachelor's degree program.
None above education listed above.
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
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Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.