ABHIJITH MADHUSUDHANAN
Hamilton,ON
Summary
Dedicated and hardworking pharmacy graduate with around 4 years of project coordination experience at Parexel International and 1 year experience at Metapharm clinical research Inc. Skilled in different types of EDC databases and systems used in CRO's. Expertise in Veeva Vault (TMF) illustrated around 4 years of hands-on experience and confidentially maintained all the project documents throughout the CT (Clinical Trial) period. Possess a demonstrated track record of successfully coordinating multiple complex projects, meetings, and training activities. Recognized for initiative, organization, time management, and task management.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Clinical Project Coordinator
Metapharm Clinical Research Inc
11.2022 - Current
- Coordinated internal audits for quality assurance purposes, driving continuous improvement within the organization.
- Facilitated cross-functional team meetings to provide updates on project status and address any challenges.
- Mitigated risks associated with clinical trials by conducting thorough risk assessments and establishing contingency plans.
- oversaw the projects' scope, budget, and schedule in addition to the work's integrity and progress with regard to deliverables.
- Participated in all project phases, including scheduling, documenting, tracking, and planning.
Project Data Coordinator
Parexel International
03.2019 - 09.2022
- Provided all administrative support in system access management for project, program, and partnership level
- Improved data accuracy by implementing stringent quality control measures for data management
- Initiated and maintained core project documents and study documents in TMF throughout the project with versions for multiple studies
- Scheduled and coordinated meeting with study leads, Investigators, CRAs and sponsors for the smooth deliverables of the project
- Prepared and distributed meeting minute, agendas, action items and followed up with study team for the closure of the action items
- Ensured the trial teams were aware of the most recent developments or updates in documentation management in TMF
- Identified and addressed potential study risks and escalated the project risks and outcomes to the senior project manager for preventive action (CAPA)
- Coordinated with the system set-up analyst to ensure that Clinical Trial Systems (IH, Medidata, PMED, and Vault e-TMF) and system interfaces are functioning and are ready for the project teams
- Performed review for SOP, PMP, RMP, PSSMP, study protocols, and Teamlist in Veeva Vault (TMF) in a timely manner
- Collaborated with all the functional leads to ensure that project deliverables are completed on time
- Extracted internal and external system reports from Vault e-TMF and provided the required information to the project team
- Coordinated with project leads to ensure documents are archived and final reports are handed over to the sponsor
- Supported in the TMF's close-out process and oversaw the planning, monitoring, and recording of all trial-level records in accordance with internal and external guidelines.
Pharmacist
Practo Technologies
08.2017 - 02.2019
- Approval of online prescriptions
- Maintained up-to-date knowledge on emerging pharmaceutical trends by attending conferences and completing continuing education courses
- Educated patients about possible drug interactions and gave special administration instructions.
Education
Bachelor of Pharmacy -
JSS University
06.2017
Skills
- Workflow Coordination
- Proficient in PMED, and Veeva vault
- Expertise in EDC, Mytrial (IVRS)
- Knowledge in ICH-GCP guidelines
- Ability in handling multiple projects
- Problem-solving skills
- Excellent time management skill
- Six Sigma-Green Belt
- Client focused approach to work
- Microsoft Office suite
Websites
Certification
Six Sigma Green Belt
CAPM (under progress)
Therapeutic Experience
- Pulmonary Disorders Phase - IV
- Tuberculosis Phase - II/III
- Global Managed Access Program studies - system and key documents management
- Time management
- Financial & Resource Management
- Arranging Internal & client meetings
- Electronic Trial Maser File management
Timeline
Clinical Project Coordinator
Metapharm Clinical Research Inc
11.2022 - Current
Project Data Coordinator
Parexel International
03.2019 - 09.2022
Pharmacist
Practo Technologies
08.2017 - 02.2019
Bachelor of Pharmacy -
JSS University
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