Project Coordinator

4 days ago

Bengaluru, India MUM Fortrea Development India Pvt Ltd Full time
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
The mission of the Project Management Academy (PM Academy) is to early identify and develop potential clinical project management leaders of the future. Within a face-to-face, continuous learning environment, Project Coordinators (PC) are the right hand support to the Project Lead.
The Project Coordinator II performs the essential duties with occasional guidance and support from the Fortrea web of support that includes, but is not limited to, the Project Lead(s), Line Manager, mentor, and subject matter experts. As s/he progresses along the learning curve, the Project Coordinator II may train & mentor other PM Academy PCs in some areas of expertise.
Operational Delivery:
• TIME: Work with project team to set up and maintain project schedule. Update timelines within MS Project, CTMS, project governance tool, and other trackers. Escalate when timelines are at risk
• COST: Work with Project Lead to assist with TAQ/TAR (timesheet vs budget) reviews; vendor financial tracking & reconciliation; sponsor contract financial tracking & reconciliation; and final project financial reconciliation
• SCOPE: Work with Project Lead to conduct Contract vs Study Plan Review. Maintain tracker of out of scope (OOS) work performed. Assist the Project Lead to create Change Order Forms. Provide vendor management, escalating OOS activities to Project Lead.
• RISK: Update Xcellerate Risk Identification & Issue Resolution (RIIM) tool; and follow outstanding action items to resolution. Ensure Xcellerate Risk Assessment Categorization Tool (RACT) is complete, using Xcellerate Risk library. Work with Study Team to ensure Protocol Deviations are updated in Xcellerate RIIM
• QUALITY: Update Project Governance Tool on a monthly basis. Support the study team to identify, prevent and close quality compliance gaps. Support the Project Lead to prepare for audits and/or investigations, including creation of story boards to documenting issues that may occur during the study. Support study team to ensure timely closure of audit/inspection CAPAs
• TEAM COMMUNICATION: Facilitate study team communication & collaboration by attending & setting up team meetings; updating the ADI log; updating the Task Order Matrix; maintaining the Project Directory; setting up distribution lists, SP sites, mailboxes, and other collaboration tools; and set up / maintain project-specific trackers
• TEAM COLLABORATION: Collaborate with other support functions to facilitate timely TMF uploading, TMF reviews, TMF issue resolution, systems access, project-specific training curriculum, and other delegated tasks. Monitor for, escalate, and help to enforce redaction of subject sensitive information and identifiers in any study documentation
• LESSONS LEARNED: Work with Study Team to maintain Lessons Learned tracker
• OTHER: Performs other duties as requested by Line Manager, Project Lead, or other business leaders.
Minimum Required:
Minimum 2-10 years experience
¨ Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
¨ Computer competency with various programs (e.g., Microsoft Word, Excel, Project, Access and Power Point)
¨ Ability to develop accurate study related documents with minimal supervision
¨ Ability to communicate verbally and in writing
¨ Ability to mentor junior staff
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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