PRIYA KUMARI
Bangalore
Summary
Accomplished Clinical Project Associate with a proven track record at LabCorp, adept in TMF Management and Maintenance and cross-functional collaboration. Excelled in stakeholder management. Skilled in Veeva Vault and Agile methodologies, I drive project success through effective documentation control and quality review. Resourceful Project Associate known for productivity and efficient task completion. Specialized in project management tools, stakeholder communication, and risk assessment. Excel in teamwork, adaptability, and problem-solving to ensure project success.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Clinical Project Associate
LabCorp
Bangalore
07.2023 - Current
- Worked as a workload dealer, delegating duties and day-to-day tasks to associates, maintaining the task inventory by prioritizing high-priority projects on time without compromising quality.
- Proficiently handled multiple projects simultaneously, utilizing time management strategies to meet deadlines consistently.
- Managed day-to-day tasks, ensured quality and productivity, which includes resending lab reports, adhering to the process of sample disposal, and acting as a liaison between the client and the disposal team.
- Build purchase orders and billing requisition form so that records are maintained about essential services provided by the company.
- Managed project and technical documentation in an appropriate manner
- Provided administrative and technical support to internal departments as needed
- Also worked on the data revision request to ensure the accuracy, consistency, and integrity of the collected data.
- Performed checks to ensure the quality of the work completed.
- Ensured timely escalation, issue resolution, and other duties as assigned by management.
- Outlined work plans, assessed resources and determined timelines for projects.
- Conducted regular team meetings to monitor project progress and address any concerns.
- Forecasted, scheduled and monitored project timelines, personnel performance, and cost efficiency.
- Assisted project managers by identifying gaps and establishing best practices for existing and upcoming project initiatives.
- Prioritized tasks and assignments to maintain project momentum and meet critical deadlines.
- Utilized project management software tools to track project timelines, tasks, and deliverables.
Project Coordinator - II
Thermofisher Scientific
Bangalore
11.2021 - 07.2023
- Maintained and managed the Trial Master File (TMF) to ensure completeness, accuracy, and regulatory compliance.
- Assisted in audits and inspections, providing TMF-related support. Coordinated, oversaw, and completed functions on assigned trial activities detailed in the task matrix.
- Performed quality control checks on TMF content to ensure compliance with GCP, and inspection readiness.
- Contributed as a Subject Matter Expert (SME) in the field of TMF Lead activities within the Quality Management System.
- Performed department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system
- Ensured allocated tasks are performed on time.
- Proactively communicates any risks to project leads, and line manager, as appropriate.
- Generated weekly, monthly, quarterly reports summarizing key performance indicators.
- Developed and maintained project plans, schedules and budgets to ensure successful completion of projects.
- Developed and implemented project tracker or calendar to meet and maintain standards.
- Liaised with project managers to evaluate project scope and define milestones and deadlines.
- Performed regular reviews of project documentation and communicated results with relevant personnel.
- Coordinated with internal departments as well as external vendors to ensure successful completion of tasks.
- Collaborated with cross-functional teams to define requirements for new initiatives.
- Liaised between departments, vendors and clients to monitor project expenses.
- Prepared status reports to communicate progress to stakeholders and management teams.
- Facilitated meetings between stakeholders to discuss project requirements, objectives or outcomes.
- Supported the maintenance 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/client, and tracking of project level activity plans in appropriate system, also ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system
- Provided system support (i.e. GoBalto & eTMF)
- Supported RBM activities: Performed administrative tasks on assigned trials, including but not limited to timely processing of documents sent to the client (e)TMF as assigned, and performing (e)TMF reviews.
- Performed mass mailings and communications as needed and provided documents and reports to internal team members.
- Identified training needs for team members in order to keep them up to date.
- Served as point-of-contact to support order management, testing and reporting.
- Created project status presentations for delivery to customers or project personnel.
Project Coordinator - I
Thermofisher Scientific
Bangalore
02.2020 - 11.2021
- Collected trial-specific requirements to ensure the study setup of the TMF and the creation of the study-specific TMF plan.
- Worked as a TMF Specialist to ensure document metadata entry accurately reflects trial specific requirements and is entered in a consistent manner.
- Ensured that the Essential Documents Lists are regularly updated by the study team, allowing the completeness of the TMF to be accurately assessed.
- Conducted periodic quality reviews of study documents to identify missing documents or poor quality documents, and liaises with the document owners to ensure that all findings are addressed in a timely manner.
- Support is provided in audits and inspections to ensure that auditors have access to TMF.
- Processed study documents in accordance with the client and study requirements, as per the study-specific process.
- Maintained study files as per the study and/or client requirements.
- Proactively communicates any risks to project leads and line managers as appropriate.
- Performed completeness check, quality, and timeliness of TMF content for all assigned studies until closeout.
- Supported the maintenance 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/client, and tracking of project-level activity plans in the appropriate system.
- Ensured that the TMF is up to date by following file review schedules, and documenting findings in the appropriate system.
- Prepared status reports to communicate progress to stakeholders and management teams.
Education
Clinical Research and Clinical Data Management -
Cliniminds Institute
Bangalore01.2019
Bachelor's - Pharmacy
Invertis University
Bareilly U.P01.2018
Skills
- Veeva Vault
- CTMS
- Gobalto
- RACT
- Zavacore
- Gopher
- TMF Management and Maintenance
- Document Control and Quality Review
- Inspection and audit readiness
- Service delivery
- Stakeholder management
- Agile methodologies
- Cross-functional collaboration
- Stakeholder communication
- Administrative support
- Cross-functional team collaboration
- Mentoring
- Task prioritization
- Documentation management
Certification
- Agile Project Management Certifications, 02/24
- Agile Scrum Certifications
- Pragmatic Clinical Trials and Healthcare Delivery Evaluations - EDx 'The University of Texas M.D Anderson Cancer Center
Therapeutic Area Worked
- Hematology
- Influenza
- Hepatitis Chronic
- Covid 19
Accomplishments
- ACE Award Receiver
- Will To Win
- Game Changer
Timeline
Clinical Project Associate
LabCorp
07.2023 - Current
Project Coordinator - II
Thermofisher Scientific
11.2021 - 07.2023
Project Coordinator - I
Thermofisher Scientific
02.2020 - 11.2021
Clinical Research and Clinical Data Management -
Cliniminds Institute
Bachelor's - Pharmacy
Invertis University