Dr Rucchii Joshi

Senior Project Manager, Clinical Operations (Global Projects) Jan 2025 -

HRAPL

• Overseeing end-to-end clinical operations for domestic and international trials, ensuring seamless execution across all study phases
• Independently manages, supervises and oversees activities of reporting Project managers, Project Coordinators, Clinical Research Coordinators, and Clinical Research Associates, also, passively manages the Start-up team as and when required. Responsible for performance development discussions, maintaining metrics of the direct reports and ensuring the team is functioning as per the organization’s requirements and expectations
• Managing site selection, investigator evaluations, and pre-study activities to optimize trial feasibility
• Driving effective communication with global teams and senior management to align with client expectations and project goals
• Ensuring adherence to study timelines, quality standards, and budgets while maintaining regulatory compliance
• Developing and negotiating study proposals, budgets, and Clinical Trial Agreements (CTAs) with sponsors
• Leading patient recruitment strategies, monitoring progress, and implementing best practices across sites
• Tracking and reporting study metrics, providing critical insights to internal teams and sponsors
• Coordinating project handovers, resolving study-related challenges, and maintaining sponsor relationships
• Ensuring compliance with New Drug&Clinical Trial Rules, ICH-GCP, FDA, EMEA, and Indian regulatory guidelines
• Supporting business development by conducting feasibility assessments, drafting proposals, and engaging with clients
• Establishing and refining SOPs, operational plans, Monitoring plans, Monitoring Visit Report templates and risk mitigation strategies for clinical research projects.
• Drafting, designing and executing PDC metrics, and RACI structure for the organization as per their requirements
• Conducting site visits, audits, and inspections to ensure protocol adherence and regulatory preparedness
• Mentoring and training research teams, fostering excellence in study execution and reporting accuracy.
• Handling successful Induction/Onboarding Programs within the company for New Hires
• Overseeing quality management processes to uphold high clinical trial standards
• Providing comprehensive audit and inspection support, ensuring all documentation meets compliance requirements

Clinical Researcher Apr 2024 - Dec 2024

Clinical researcher Freelancer, freelance

• Designed, managed, and executed global clinical research trials from start-up to close-out
• Led feasibility assessments, site selection, and investigator identification for multi-site studie
• Managed EC submissions, CTRI registrations, contracts, NDAs, SOWs, and vendor coordination
• Developed study budgets, proposals, and operational frameworks to enhance study

  efficiency

• Created and implemented SOPs, study projections, and start-up strategies

• Provided recruitment support, troubleshooting investigator concerns, and optimizing site

  performance

• Trained and mentored research teams, improving study execution and regulatory adherence

• Ensured regulatory compliance with international and national clinical trial guidelines

Clinical Operations Manager Sep 2021 - Mar 2024

Parexel

• Monitoring project performance for accuracy and completeness in documentation and correspondence.
• Leading sponsor calls, representing the ClinOps Team, and implementing project requirements.
• Contributing as a senior-level member of project teams, ensuring high-quality delivery of deliverables and generating study-specific status reports.
• Supervising and Managing a huge team of Direct reportees including Study Startup initiation CRA, Clinical Trial Assistants, and On-site CRAs who were associated with multiple global studies
• Facilitating metric collection and resource planning to keep projects on schedule and within budget
• Overseeing staffing, assignments, quality control, and efficiency of project deliverables, including resource planning and monitoring
• Liaising between the project team, sponsors, and management for performance reviews
• Directing project team members and fostering a collaborative work environment
• Managing study timelines, including patient recruitment, retention, and data cleaning
• Conducting quality checks on Central Files to ensure work integrity
• Implementing process improvements within projects and participating in revenue forecasting
• Managing project scope, collaborating on database lock activities and changes with project leaders
• Ensuring completion of all administrative closeout procedures in line with project checklists
• Providing technical support to staff, guaranteeing they have the necessary knowledge for their duties
• Driving staff performance to meet productivity and quality metric.
• Recruiting, retaining, and developing a skilled team to exceed client expectations
• Enhancing staff efficiency in prioritizing work and improving performance
• Participating in staff performance and salary reviews as per corporate standards
• Engaging in client networking, public speaking, and contributing to project bids and client presentations Managing client or account activities as required
• Participating in system and standards improvement initiatives
• Maintaining productivity and fostering a positive work environment

Lead Senior Site Report Specialist Jul 2019 - Sep 2021

IQVIA

• Managed and oversaw visit report reviews for studies, ensuring compliance with protocols, SOPs, and GCP guidelines
• Conducted comprehensive reviews of visit reports, ensuring adequate documentation and follow-up for high-quality SVRs
• Led as SRS on multiple projects, focusing on team coordination and quality control
• Oversaw project team compliance with SOPs, maintaining direct communication with CRAs and Dedicated Line Managers (DLM)
• Ensured visit report alignment with audit or inspection findings, implementing corrective/preventative action plans
• Collaborated with project teams to minimize report corrections, offering support and mentoring to CRAs
• Supported Open Action Items Management, working closely with CRAs and study teams
• Provided team support through quality checks, data trending, backup support, and mentoring junior SRSs
• Developed study operational plans within clinical SOPs and FDA guidelines, integrating clinical/medical strategies with regulatory team
• Assisted in clinical trial startup phases, including investigator identification, meetings, and site initiation preparations
• Maintained tracking systems for accurate study progress monitoring and timely report production

Clinical Research Associate/Acting Associate Project Manager Jul 2017 - Jun 2019

Baxter

• Developed operational plans within clinical SOPs and FDA guidelines, integrating clinical strategies with regulatory and team collaboration
• Acted as backup CPM, addressing and resolving issues efficiently.
• Responsible for managing and coordinating core Clinical Operations tasks of assigned studies and projects, as directed by the CPM
• Performed on-site and remote monitoring, including SIV and COV activities
• Managed project aspects like budgeting, vendor selection, and site visits
• Facilitated communication with study sites and teams, including CROs
• Supported CPM in enhancing study-specific procedures and processes
• Managed study projections in CTMS, including patient ramps and milestones, and executed Jasper reports. Maintained CTMS for assigned studies in collaboration with CPM
• Supported clinical trial startups, including investigator identification and site initiation preparations
• Ensured accurate tracking of study progress and timely report production
• Handled study documentation compliant with GCP and SOPs
• Participated in audit preparations, both internal and external
• Contributed to study documentation development and prepared clinical study summary reports
• Managed eTMF, designing metadata fields, uploading, and approving documents
• Reviewed and drafted study documents, ensuring protocol and GCP compliance
• Managed regulatory documentation as per FDA requirements

Clinical Study/Research Associate Nov 2016 - May 2017

AbbVie

• Specialized in remote monitoring and study start-up, with expertise in QC and monitoring of clinical trial documents
• Performed critical reviews and quality control to ensure document accuracy and completeness, facilitating investigational product release to study sites
• Proficient in CTMS and eTMF systems, including Veeva VAULT, RAVE, IMPACT, eDocs, GEARS, Zephyr, and specific expertise in Veeva Vault operations
• Maintained an audit-ready trial master file (TMF), ensuring site documentation was current and compliant with regulatory requirements
• Prepared sites for Site Initiation Visits (SIVs), managing required initiation supplies
• Managed the TMF, ensuring document accuracy, completeness, and consistency with SOPs and regulatory standards
• Developed and executed study/site start-up plans, coordinating documentation submission to the IRB and managing site start-up processes
• Handled submission requirements for each site, including IRB compliance and contract execution
• Tracked and reported site/study status, managing Country&Study level trackers
• Participated in regulatory and QA audit preparations, coordinating site communications and maintaining task prioritization
• Ensured availability of required documentation in the Investigator's Site File
• Submitted documentation for Clinical Study Reports (CSRs) or regulatory filings, collaborating with clinical and field operations teams
• Managed site and study document audits, using internal systems and procedures, and generated status reports as needed
• Acted as central liaison for cross-functional teams and the regulatory department, addressing compliance issues
• Conducted quality checks for GCP compliance and regulatory agency requirements
• Managed global site operations in the US, Puerto Rico, Canada, and other countries

Clinical Research Coordinator (Acting Role of Clinical Research Associate) Sep 2016 - Nov 2016

ACRI

Clinical Researcher Freelancer Feb 2016 - Aug 2016

Freelancer

Clinical Research Coordinator Aug 2011 - May 2014

KEM Hospital and Research Center

University of West Midlands, UK 2009 - 2010

Field of study: Emergency Medical Services
Degree: Post Graduate Diploma

Maharashtra Univeresity of Health Sciences 2008 - 2011

Field of study: Medicine
Degree: MD

University of Boston, USA 2007 - 2008

Field of study: Gynaecology and Obstetrics
Degree: Associate Degree

Maharashtra University of Health Sciences, India 2000 - 2007

Field of study: Homeopathic Medicine and Surgery
Degree: BHMS