Work Schedule
Other
Environmental Conditions
Office
Job Description
This is an 11-month contract position based in Bangalore and requires candidates to work in the afternoon shift.
- Coordinates, oversees and completes functions on assigned trial activities detailed on the task matrix.
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Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. Follows up for resolution of findings and raises whenever vital.
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Ensures allocated tasks are performed on time, within budget and to a high quality standard. Bring ups in cases of variances (overburn/underburn) for self and junior PSCs, reviews and re-distributes the tasks based on junior PSC’s free capacity
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Supports the maintenance and oversight of study specific documentation and global support with specific systems, tools and trackers to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system.
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Provides system (i.e. CTMS, Oracle Activate & eTMF) support by managing the access requests, supervising study level documents, maintaining audit readiness and presenting the non-compliance to the study team and suggesting resolution.
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Performs administrative tasks on assigned trials including, but not limited to: timely processing of documents sent to CRG's/Client eTMF as required, performing CRG's/Client eTMF reviews and coordinating and proposing issue resolution, performing mass mailings and communications as needed, providing documents and reports to internal team members.
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Supports scheduling and organization of client and/or internal meetings with completion and distribution of related meeting minutes and follow up for closure of action items, if required.
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Exports and reconciles study metrics reports, and if required analyzes and identifies issues (if involved in a Lead role.
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Maintains and regularly checks for correctness of vendor trackers.
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Drives and coordinates the compilation of Investigator Site File (ISF) template, pharmacy binder with instruction from the Clinical Team Manager.
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Attends Kick off and Project Launch meetings and takes notes when required, supports initial study set-up.
Education and Experience:
High / Secondary school diploma/ equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 0 to 4 years).
