Project Support Coordinator - 11 Months Contract
Thermo Fisher · Remote, India
Thermo Fisher · Remote, India
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. • Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. Follows up for resolution of findings and raises whenever vital. • 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 • 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. • 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. • 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. • 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. • Exports and reconciles study metrics reports, and if required analyzes and identifies issues (if involved in a Lead role. • Maintains and regularly checks for correctness of vendor trackers. • Drives and coordinates the compilation of Investigator Site File (ISF) template, pharmacy binder with instruction from the Clinical Team Manager. • Attends Kick off and Project Launch meetings and takes notes when required, supports initial study set-up. Education and Experience: High / Secondary school diploma/ equiva</span