Amee Shah
Lumberton,NJ
Summary
Dedicated clinical project manager experienced in complying with study protocols, standard operating procedures and good clinical practices. Practiced problem-solver with strong attention to detail. Well-organized and hardworking with excellent communication and planning skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
5
5
years of professional experience
Work History
Project Manager, FSPx (SPOT Planner for BMS)
Fortrea/BMS
Lawrenceville, United States of America
08.2023 - Current
- Worked as a Study Planning Optimization Tool (SPOT) Planner on Full SPOT and SPOTLite Studies. Gained experience in Project Web App (PWA) while managing multiple templates for early, late and cell therapy clinical studies.
- Responsible for project delivery with regards to agreed time, scope, cost and quality
- Served as client primary contact for areas assigned by Project Manager (PM), Senior Project Manager (SPM), or Associate Director (PD)
- Assisted in the leadership of the core project team, as directed by PM/SPM/PD to facilitate their ability to lead extended cross-functional project team including the maintenance of timelines in MS Project, creation of PowerPoint presentations and storyboards and maintenance and escalation of items into an ADI log and/or RACT
- Followed project issue escalation process as defined by the Quality Council
- Under direction of PM/SPM/PD, tracked project progress against financial milestones using applicable financial systems
- Under direction of PM/SPM/PD, proactively led quality control and risk assurance activities to ensure project deliverables are met according to regulatory, organization and client requirements
- Assisted in the successful design, implementation, tracking and revision of project plans for assigned projects
- Assisted all staff allocated to assigned projects in adhering to professional standards and SOPs
- Tracked and maintained key project performance indicators for client specified metrics
- Contributed and participated in the delivery of presentations for new business.
- Advised other departments on best practices related to managing large-scale projects.
- Acted as Subject Matter Expert to mentor Sr. CRAs, CRAs and CTAs on topics such as Vendor Management and Effective Resourcing.
Project Manager
ICON Clinical Research
Remote, Pennsylvania, United States of America
11.2022 - 08.2023
- Responsible for projects focused on patient-centered research, market access, health economics and outcomes research and epidemiology
- Managed project budget, timelines, and resources by implementing and managing project changes and interventions to achieve project outputs
- Developed risk mitigation strategies by creating and implementing risk assessment categorization tool for all projects
- Tracked project progress and reported to stakeholders on weekly basis
- Provided direction and support to project team by conducting weekly check-ins
- Partnered with wider ICON teams for timely completion of project milestones and maintained strong relationships with delivery teams
- Advised other departments on best practices related to managing large-scale projects.
- Participated in cross-functional teams responsible for developing innovative solutions for complex problems.
- Ensured client satisfaction is maintained from proposal through delivery.
Clinical Operations Manager
CPC Clinical Research
Remote, Colorado, United States of America
10.2021 - 09.2022
- Defined and monitored project scope, timelines, and deliverables from project initiation to close-out
- Developed and reviewed essential study documents including protocols, case report forms (CRFs), source documents, project management plans, monitoring plans, reference tools, and study manuals
- Identified project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation
- Developed and managed site and vendor contracts including investigational product (IP) supply, interactive voice/web response system, electronic data capture system, core labs and other applicable clinical services
- Used performance metrics and quality indicators to assist the Executive Clinical Operations Manager in driving study execution.
- Worked with the Business Development team on budgets, proposals and change orders
- Ensured sponsors are aware of and in agreement on any change in project scope that has financial or resource impact by routinely advising management on project status
- Scheduled project team meetings and prepared meeting agendas and minutes as needed
- Oversaw timely and accurate entry and cleaning of data for all study databases; maintained and filed data management documentation as required
- Ensured overall quality of projects and deliverables through collaboration with internal and external stakeholders.
- Provided Head of Trial Master File scope of service to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper
- Functioned as point person for study team TMF questions and managed close-out of TMF-related issues.
Clinical Project Coordinator
Zydus Discovery DMCC
Jumeirah Lake Towers, Dubai, United Arab Emirates
03.2019 - 01.2021
- Worked in conjunction with Project Director (PD) to formulate, track, measures and maintain project specific matrix without the employment of a CRO
- Assisted PD with identification of changes in scope of work
- Assisted clinical operations team with study management to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP and applicable SOPs
- Maintained support responsibility, including scheduling, managing agenda updates, and meeting minutes for project team meetings and other meetings, as assigned
- Provided project support including development of monthly reports, newsletter, project management and communication trackers
- Provided project administrative support including mass site communication distribution, shipping, filing, tracking and status summarization, as appropriate
- Participated and assisted in planning of vendor or investigator meetings and development of required material including training tools
- Initiated contract/budget requests and tracked ongoing status
- Participated in vendor selection, qualification, and ongoing vendor management
- Assisted in protocol writing and managed startup activities for sites selected in US.
Education
Post-Graduate Diploma in Clinical Pharmacology -
University of Glasgow
Glasgow, Scotland, United KingdomBachelor of Engineering (Hons.) in Biotechnology -
Birla Institute of Technology and Science - Pilani
Dubai, United Arab EmiratesSkills
- Contract Management
- Procedure Development
- Project Planning
- Technical Support
- Risk Management
- Work flow planning
- Strategic Planning
- Resource Allocation
- Document Management
- Compliance Monitoring
Therapeutic Experience
- CardioMetabolic - Metabolic and Cardiovascular Risk - Type I Diabetes and Type II Diabetes (Phase II)
- Cardiovascular Disease - Peripheral Artery Disease, PAD, PAOD (Phase II)
- Immune Mediated Inflammatory Disease (IMID): Rare Disorders - Other Rare Disorders (Primary Biliary Cholangitis)(Phase II and IIb)
- Infectious Disease: Vaccines for bacterial or viral disease prevention - COVID-19 (Phase III, Health Technology Assessment, Heath Economic Outcomes Research and Market Access), Respiratory Syncytial Virus (RSV)(Health Technology Assessment, Heath Economic Outcomes Research, Epidemiology and Market Access)
- Other: Non-Inflammatory, non infectious Gastroenterology - Non-Alcoholic Fatty Liver Disease (Phase IIa), Non-Alcoholic Steatohepatitis (NASH) (Phase II and III), Other GI (Barrett's Esophaegus) (Phase II)
Systems Experience
- Microsoft Project: 3 years
- Cloudbyz (CTMS): 4 months
- DataTRAK (CTMS & EDC): 6 months
- SureClinical (eTMF): 1 year
- Octalsoft (CTMS & eTMF): 2 years
- Oracle (EDC): 2 years
- Veeva Vault (eTMF): 3 year
Languages
Hindi
Full Professional
Gujarati
Native/ Bilingual
References
References available upon request.
Timeline
Project Manager, FSPx (SPOT Planner for BMS)
Fortrea/BMS
08.2023 - Current
Project Manager
ICON Clinical Research
11.2022 - 08.2023
Clinical Operations Manager
CPC Clinical Research
10.2021 - 09.2022
Clinical Project Coordinator
Zydus Discovery DMCC
03.2019 - 01.2021
Post-Graduate Diploma in Clinical Pharmacology -
University of Glasgow
Bachelor of Engineering (Hons.) in Biotechnology -
Birla Institute of Technology and Science - Pilani