Project Management Clinical Research

RISHITA DHAMSANIA

Old Bridge, NJ *****

*******.*********@*****.*** 732-***-****

PROFESSIONAL SUMMARY

Results-driven professional with over 10 years of experience in clinical research, regulatory compliance, and project management within the life sciences industry. Known for fostering collaboration across cross-functional teams and achieving operational milestones. Demonstrates expertise in GCP/ICH compliance and process optimization, with a hands- on approach to delivering high-quality results in fast-paced environments. SKILLS & CERTIFICATIONS

• Technical Skills: Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Project Management, Communication tools, Regulatory Compliance (ICH-GCP)

• Core Competencies: Project Planning, Risk Mitigation, Data Analysis, Site and Vendor Management

• Soft Skills: Leadership, Communication, Problem Solving, Adaptability, teamwork and Collaboration

• Certifications: Six Sigma Green Belt

PROFESSIONAL EXPERIENCE

Study Manager

Parexel FSP on assignment to Merck – Remote

Feb 2021 to March 2025

• Oversaw the operational planning and execution of Phase I, II and III Oncology clinical trials, ensuring strict compliance with Merck SOP, GCP, and ICH guidelines.

• Provided operational support across global scientific and medical functions, ensuring compliance with GCP/ICH guidelines and achieving a 95% milestone success rate.

• Led and supported key aspects of study planning and execution, including data management deliverables, trial timelines, country and site selection, site materials preparation, system updates, investigator meetings, communication plans, quarterly newsletter publications, and study close-out activities.

• Facilitated communication with study sites, reviewed site-level informed consents and patient-facing materials, and internal teams to resolve conflicts related to study data and operations effectively.

• Liaised with vendors such as IRT, imaging, central labs, eTMF, EDC, and translation services.

• Delivered comprehensive project status reports and performance metrics to leadership, enhancing transparency and decision-making.

• Ensured accurate and timely data collection across more than 50 study sites.

• Addressed and resolved site-specific data discrepancies, reducing reporting errors by 15%.

• Directed team efforts in timeline management, risk identification and mitigation, and issue resolution to maintain project efficiency.

• Maintained and updated Clinical Trial Management System (CTMS) and Trial Master File (TMF) throughout the study life cycle

Clinical Project Manager

Stryker (short term contract with IQVIA) – Remote

December 2020 to February 2021

• Spearheaded the entire project life cycle from definition through implementation.

• Maintained team focus, achieving timely deliverables.

• Developed project plan and drives project milestones

• Defined project goals and communicated expectations to stakeholders, improving alignment.

• Monitored project risks and implemented mitigation strategies. Clinical Project Manager

BioClinica – Princeton, NJ

March 2019 to December 2020

• Managed budgets exceeding $2M per project, ensuring fiscal responsibility.

• Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting

• Managed clinical trials from initiation to completion across Phase 1–4 studies

• Understanding SOPs and working closely with QA for clarification and documentation of deviations

• Training and maintaining project team knowledge and applications of SOPs

• Conducted financial forecasting and monthly billing with 99% accuracy.

• Cross trained among different therapeutics areas; Neuroscience (CNS), Cardiovascular, and Oncology

Regulatory Affairs Specialist

Reckitt Benckiser (short term contract with Kelly Services) – Parsippany, NJ October 2018 to November 2018

• Ensured 100% compliance in product labeling and regulatory submissions.

• Delivered timely product registrations to meet global distribution needs.

• Adjusted timelines to accommodate shifting regulatory requirements.

• Delivered project and brand specific activities such as registrations, submissions, labeling, and review. Bioanalytical Lead Scientist/Study Coordinator

Covance Inc (short term contract with SRG Woolf and Aerotek) – West Trenton, NJ July 2017 to July 2018

• Directed protocol design for over 10 studies, consistently meeting FDA standards.

• Mentored junior staff to improve efficiency by 25%.

• Authored comprehensive reports detailing clinical findings and outcomes.

• Performed quality control reviews, ensuring data accuracy for regulatory submissions.

• Drafted clinical protocols, amendments, study schedules and lab manuals.

• Collaborated entire study and wrote a report including table and figures according to FDA and GLP regulations.

• Supported cross-departmental collaboration to meet tight study deadlines. Associate Research Scientist

Bristol-Myers Squibb (short term contract with Townsend and Associates) – Lawrenceville, NJ July 2015 to July 2016

• Collaborated in the development and validation of Thermo LC-MS/MS assays and performed study sample analysis for GLP and Non-GLP studies for clinical and pre-clinical trials.

• Collaborated in the development and validation of procedure for protein/ peptide analysis using HPLC and Mass Spectrometry for drug discovery

• Enhanced biospecimen sampling accuracy, reducing errors by 20%.

• Supported method development for advanced analysis, bolstering discovery efforts.

• Managed and updated electronic laboratory notebooks (ELN), improving workflow efficiency.

• Collaborated on analytical studies, ensuring compliance with GLP standards. Laboratory Supervisor

Xenobiotic Laboratories – Plainsboro, NJ

June 2013 to July 2015

• Contacted and coordinated vendor for maintenance services

• Efficiently and safely supervised the daily operation and upkeep of lab and equipment with new federal, state and industry standards to meet OSHA and GHS requirement

• Coordinated maintenance schedules, reducing equipment downtime by 30%.

• Trained new hires, standardizing onboarding processes for lab personnel. Associate Scientist

Xenobiotic Laboratories – Plainsboro, NJ

June 2013 to July 2015

• Weighed, pipetted, and extracted bioanalytical samples such as blood, urine, serum, plasma, etc. using provided method for drug development

• Organized tests to demonstrate for Method validation and Method development

• Processed over 200 monthly bioanalytical samples with high accuracy.

• Supported validation processes that drove 15+ successful drug initiatives.

• Performed sample analysis including cell-based assays, immunoassays, and LC/MS/MS using Watson LIMS, Analyst, and MassLynx

EDUCATION

Master of Science in Biomedical Engineering

New Jersey Institute of Technology – Newark, NJ

May 2018

Bachelor of Science in Biotechnology

Kean University – Union, NJ

January 2013

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