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Project Support Coord

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Thermo Fisher Scientific

1mo ago

  • Job
    Full-time
    Mid Level
  • Research & Development
    Healthcare
  • Bangalore

AI generated summary

  • You need a high school diploma or equivalent, relevant qualifications, and at least 4 years of experience to perform this role effectively.
  • You will coordinate trial activities, manage documentation, support system oversight, handle administrative tasks, organize meetings, track metrics, and assist in study setup.

Requirements

  • 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 4 years).

Responsibilities

  • 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.

FAQs

What is the primary responsibility of the Project Support Coordinator?

The primary responsibility is to coordinate, oversee, and complete functions on assigned trial activities as detailed on the task matrix.

What kind of environment does the Project Support Coordinator work in?

The Project Support Coordinator works in an office environment.

What qualifications are required for the Project Support Coordinator position?

A high/secondary school diploma or equivalent, along with relevant formal academic or vocational qualifications, is required.

How much prior experience is needed for this role?

The role typically requires previous experience comparable to at least 4 years that provides the necessary knowledge, skills, and abilities.

What types of documentation will the Project Support Coordinator be responsible for?

The Coordinator will be responsible for maintaining study specific documentation, managing global support systems, tools, trackers, and ensuring audit readiness of study level documents.

Is the Project Support Coordinator involved in meeting organization?

Yes, the Project Support Coordinator is responsible for scheduling and organizing client and internal meetings, along with completing and distributing meeting minutes and following up on action items.

What project management tools does the Project Support Coordinator need to be familiar with?

The Coordinator should have familiarity with systems such as CTMS, Oracle Activate, and eTMF.

Will the Project Support Coordinator perform administrative tasks?

Yes, the Coordinator will perform administrative tasks related to trials, including processing documents, coordinating reviews, and mass communications.

What is meant by 'audit readiness' in the context of this position?

Audit readiness refers to maintaining compliance and ensuring that all required documentation is accurate, organized, and accessible for audits and inspections.

What kind of meetings will the Project Support Coordinator attend?

The Coordinator will attend Kick Off and Project Launch meetings and may be required to take notes during these meetings.

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Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.