ROMIL SHAH
Mansfield
Summary
A highly motivated and purposeful Clinical Research Professional with 6+ years of clinical research experience and a master’s degree in public health (Major- Health care Organization) and Doctor of Pharmacy, seeking a senior level position in a pharmaceutical company to grow professionally and further improve my skills, knowledge, and experience. Possess strong experience in clinical research implementation, clinical research projects, analyzing information for research projects, budget and contract negotiations. Proficient in financial modeling (using various tools), trend analysis and risk assessment. Exceptional leadership skills to motivate staff to perform at their best abilities and to provide solid growth of organization. Adapt to fostering and sustaining cordial, yet professional, relationships with all coworkers, management, and patients. Remarkable communicator and innovative thinker who utilizes creativity and teamwork to produce exemplary results.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Senior Clinical Financial Analyst
Medtronic
Minneapolis
05.2025 - Current
- Oversaw monthly and quarterly assessments of financial performance against budget goals.
- Collaborated with study teams and finance to prepare monthly accruals.
- Managed processing of accounts receivable and payable, generating reports as required.
- Developed and updated departmental annual operating plan (AOP).
- Reconciled monthly activity and generated year-end reports in partnership with finance.
- Administered PACS payment and resource management systems for optimal efficiency.
- Engaged with global team to resolve site contract issues effectively.
- Provided ongoing budget oversight in collaboration with key CRO partners.
Clinical Research Budget Manager
Memorial Sloan Kettering Cancer Center
New York
08.2024 - 05.2025
- Develop and lead budgets for clinical research studies, ensuring alignment with various funding sources.
- Review study documentation to create budgets, letters of intent (LOIs), and amendments, while incorporating all relevant expenses.
- Collaborate with cross-functional teams to gather cost data and assess study feasibility.
- Negotiate budgets and payment terms with industry sponsors to secure funding and improve revenue.
- Ensure compliance with regulations and internal controls while maintaining detailed tracking of budget statuses.
- Analyze budget data for accuracy and trends, and present findings to management.
Clinical Research Operations Manager
UMASS CHAN MEDICAL SCHOOL
Worcester
03.2022 - 08.2024
- Leading a team of four analysts in processing and executing financial aspects of study agreements.
- Managed the progression of a clinical project portfolio from preliminary valuation until final cost reconciliation including study budget review and financial validation.
- Negotiated over 100+ Medicine, Oncology, Neurology, Dermatology etc Budgets and Contracts.
- Provided clinical operations support in managing clinical contracting activities across multiple projects and vendors.
CLINICAL TRIAL ADMINISTRATOR II
The University of Alabama at Birmingham
Birmingham
01.2019 - 10.2021
- Managed a team of three study coordinators and collaborated on financial aspects of clinical research, including contract negotiations, updating CTMS, study start up, regular invoicing to study closeout.
- Work with sponsors and grant/contract administrators to complete clinical trial agreements through collaborative efforts.
- Plan and execute clinical research projects within specified budgetary constraints as well as develop, improve, and maintain tools to assist in the evaluation, reconciliation, creation, and negotiation of clinical trial budgets.
- Ensure timely subject recruitment and smooth implementation of studies by leading, guiding, and motivating site personnel to complete study goals.
- Collects, records, and prepares data for publication; collaborates with the Office of Grants and Contracts and the Institutional Review board and adhere to CTMS.
- Ensure appropriate distribution of documents, forms, supplies, equipment, laboratory samples, and study devices required for the execution of clinical trials.
- Responsible in Continuous Monitoring of clinical activities in CTMS and send invoices as per clinical activities done to sponsor as per defined timelines.
- Prepare research documentation and submit at several levels including keeping CTMS UpToDate. (i.e., IRB, IND or FDA submissions, educational materials, reports, grant renewals and, study forms).
- Support in recruiting, enrolling, and scheduling patients for clinical trials, as well as follow-up visits.
- Perform assigned administrative tasks to support team members with clinical trial execution.
- Provide progress reports to all customers, receive permissions for all lab results, and keep them up to speed on any protocol concerns that may arise.
- Work with medical personnel, university departments, and ancillary departments as a point of contact.
- Oversee EDC clinical database data input, data review and resolving outstanding questions in-house.
Drug Safety Associate
Synowledge LLC
Mysuru
11.2015 - 05.2016
- Responsible for final QA on all study closeout activities for all trials.
- Coding of data in the safety database.
- Collected data from patients regarding their health status and wrote the narrative for case analysis.
- Used ArisG and Sceptre database for entering data of patients and coding all necessary terms according to MedDRA, WHO-DD.
- Regularly updated the study team on the progress of multi-site clinical trials and gathered signatures as required for sponsored multi-site trials.
- Monitored source documents and case report forms to verify they are current, complete, and filed in the site's regulatory binder.
- Monitored 6-8 protocols with diverse indications across the nation to verify protocol adherence, GCP compliance, and FDA requirements.
- Provided shadow training to newly reporting research coordinators and research assistants.
- Managed all regulatory compliance and filings.
- Conducted site closeout visits as needed to assure correct drug reconciliation, test item disposal, research file accuracy and completeness, and recovery of any outstanding documentation.
- Followed the Project Operations Manual and SOPs, completed and submitted monitoring forms and site visit reports.
Intern
Basaveshwara Medical College & Hospital
11.2014 - 11.2015
- Active participation in the following activities of Clinical Pharmacy during the internship at Basaveshwara Medical College and hospital with the collaboration of SJM College of Pharmacy in various departments like General Medicine, Psychiatry, and OBG.
- Practical Training in Wards and Community.
- Providing Drug Information.
- Ward Round Participation and Medication Chart Review.
- Safety Reporting Inwards.
- Treatment Chart Review.
- Handling Patient Referral.
- Providing Healthcare services at Community Levels.
- Provide Poison Information.
- Adverse Drug Reaction Detection, Reporting, Monitoring and Documentation.
- Assessing suspected ADRs by using different causality assessments scales.
- Supporting National Pharmacovigilance program by reporting ADR on day-to-day basis.
- Patient Counselling and Designing patient Information Leaflets.
Education
Master of Public Health - Health care Organization
University of Alabama at Birmingham
Birmingham, ALDoctor of Pharmacy - Pharm-D
Rajiv Gandhi University of Health Sciences
Bengaluru, KarnatakaSkills
- Clinical-trial practices
- Drug development process
- Project management
- Team leadership
- Technical skills
- Financial analysis
- Budgeting
- Cost estimation
- Budget development
- Variance analysis
- CIOMS form completion
- Administrative support
- Pre-clinical research
- Study start-up
- Analytical mindset
- IMPACT & Medidata- CTMS
- OnCore
- EPIC
- Florence- EDC
- Tableau
- RMS
- SOPs
- PSVs
- SIVs
- Coverage analysis
- Clinical trial budgets
- Contract negotiations
- Strong computer skills
- Microsoft Office
- Process improvemen
- Critical thinking
- Conflict resolution
- Time management
- Data analytics
- Troubleshooting
- Communication skills
- Active listening
- Team player
- Contract interpretation
- Operational compliance
- Budget amendment review
- Billing
- Clinical Research Management System usage
- Purchase order processing
- Account closure request processing
- Clinical research project planning
- Budgetary constraint management
- Tool development for evaluation and negotiation
Certification
- IRB CITI Good Clinical Practice
- HIPAA Training
- Human Research IRB Training
- Oncore 2100: Financials, 10/01/22
- Oncore 2000: CRM & Admin, 10/01/22
Timeline
Senior Clinical Financial Analyst
Medtronic
05.2025 - Current
Clinical Research Budget Manager
Memorial Sloan Kettering Cancer Center
08.2024 - 05.2025
Clinical Research Operations Manager
UMASS CHAN MEDICAL SCHOOL
03.2022 - 08.2024
CLINICAL TRIAL ADMINISTRATOR II
The University of Alabama at Birmingham
01.2019 - 10.2021
Drug Safety Associate
Synowledge LLC
11.2015 - 05.2016
Intern
Basaveshwara Medical College & Hospital
11.2014 - 11.2015
Master of Public Health - Health care Organization
University of Alabama at Birmingham
Doctor of Pharmacy - Pharm-D
Rajiv Gandhi University of Health Sciences
Similar Profiles
Anna Marie ErvinAnna Marie Ervin
Sales Solutions Coordinator - Diabetes at MedtronicSales Solutions Coordinator - Diabetes at Medtronic
Emery T. DossEmery T. Doss
Mechanical Product Engineering Intern at MedtronicMechanical Product Engineering Intern at Medtronic
Karianne KirkKarianne Kirk
Senior Principal Clinical Specialist at MedtronicSenior Principal Clinical Specialist at Medtronic
Corrine HookerCorrine Hooker
Receiver at MedtronicReceiver at Medtronic
Kim-Yen DuongKim-Yen Duong
Ophthalmic Technician at Parkland HospitalOphthalmic Technician at Parkland Hospital