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Sr Project Support Coord

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Coordinate, oversee, and complete functions on assigned trial activities. Ensure tasks are performed within budget and to high quality standard. Support study documentation maintenance and global support. Provide system support and perform administrative tasks on assigned trials. Support scheduling and organization of meetings. Drive ISF template compilation. Attend project meetings and support study set-up.

Job description 

Job Description

 

  • 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 in appropriate system. Follows up for resolution of findings and escalates whenever necessary.
  • Ensures allocated tasks are performed on time, within budget and to a high quality standard. Escalates in cases of variances (overburn/underburn) for self and junior PSCs, reviews and re-distributes the tasks based on junior PSC’s free capacity (in case involved in a Lead role).
  • Supports the maintenance and oversight of study specific documentation and global support with specific systems, tools and trackers including, but not limited 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, tracking study level documents, maintaining audit readiness and communicating 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 or 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 4 years).

Set alert for similar jobsSr Project Support Coord role in Mumbai, India
Thermo Fisher Scientific Logo

Company

Thermo Fisher Scientific

Job Posted

9 months ago

Job Type

Full-time

WorkMode

On-site

Experience Level

3-7 Years

Category

Software Engineering

Locations

Mumbai, Maharashtra, India

Qualification

Bachelor or Master

Applicants

Be an early applicant

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