Rama Jaikumar

Manage and execute Global clinical trial in Oncology (Breast Indication) Phase 1a/1b study in advanced solid tumors in USA with 11 sites

Global clinical trial in Oncology (Breast Indication) 10 sites in US; 5 sites in Europe and 5 sites in France.

Lead Clinical Trial Team in key study planning, development and execution elements ensuring compliance to both GCP and ICH-GCP guidelines.

Ensure data managemend deliverables are met.

Accountable for ensuring protocol level plans.

Work closely with country affiliates to ensure country/site selection are completed and meet the needs of the recruitment deliverable.

Organize and provide Investigator Meeting and supplemental training to the Investigator Sites, Clinical Research Associates and clinical team members as needed.

Lead team for timeline management, risk identification, mitigation and issue resolution.

Operational oversight and management study specific partners and vendors.

Participate in the development or recruitment strategies to ensure milestones are met.

Implemented a tracking and follow-up tool to increase recruitment and ensure compliance with the recruitment plan.

Management of Global affiliates to ensure alignment with protocol expectations and deliverables. Ensure on-time and high-quality delivery of project specific on-site and remote monitoring services; accountability for clinical monitoring team training compliance; tracking of critical project tasks; strategic and tactical study enrollment support including, project-specific enrollment planning; and project accountability for CRA utilization

Led and managed the global phase 1 solid tumor study (with 40 sites in US, 2 sites in UK, and 1 in Ireland).

Led First-in-Human gene therapy study from start up, and tracked leukapheresis, T-cell manufacturing, and treatment processes (with 10 US sites and 5 sites in Spain and 2 sites in France). Successfully managed two other phase-1 solid tumor study.

Contributed medical/scientific/feasibility input for the development of the protocol synopsis with collaboration with country medical advisors.

Independently ensured quality and timely execution the clinical trial within timeline and budget.

Forecasted trial budget resource needs and accountable for the development, management and tracking of the budget throughout the clinical trial.

Wrote scientifically rigorous protocol with coordination of medical expert input and ensured timely finalization of document.

Responsible for authoring study-specific documents including, manual or procedures, informed consents, and site monitoring plans, and providing review and input in Investigator Brochure, Statistical Analysis Plan, and Data Validation Plan.

Closely worked with Clinical Trial to team complete feasibility and selection of countries and sites.

Ensured Investigational Product supply was obtained and in compliance with country-specific requirements.

Defined clinical outsourcing specifications for clinical trial to identify vendors, and define scope of work and contract requirements.

Tracked trial progress and milestones. Resolved issues within the team and appropriately escalated issues as needed.

Ensured ongoing data quality review, data cleaning, protocol deviation review and database lock. Escalated issues and trends as appropriate.

Lead Clinical Trial Team meetings and ensure timely communication of meeting agenda and minutes.

Contributed to the development of clinical sections of regulatory documents, including Investigator's Brochures, briefing packets, safety updated, IND/NDA submission documents, responses to Health Authority questions.

Responsible for implementation of best practices and standards for trial management including sharing lessons learned.

Developed training material materials, slide presentations, guidance documents and worksheets to train Investigators, Coordinators and Monitors for Investigator Meeting and and any other training needs.

Additional Initiatives above Senior Study Study Manager role:

• Lead a workstream for the Study Management role for the implementation of a new CTMS system with input in Planning and Payments workstreams.
• Seved as the Point of Contact/ Subject Matter Expert for Clinical Managers on the CTMS system, including:

Developed test scripts and completed system testing

Developed training plans and training materials

Provided onboarding training to new colleagues

Providing updates on systems enhancements

Addressed questions/issues and escalated as appropriate

• Appointed to the committees to provide subject matter expertise and input due to past Clinical Research experience:

IRT Governance Committee

Investigator Meeting Task force

Competency Committee.

• Mentored new and current colleagues as needed in areas or expertise.

Managed the clinical operational delivery phase I and II studies evaluating CAR-T therapy

Responsible for overall clinical operations, from start-up to maintenance

Organized and led project-specific launch activities and training for clinical team members

Successfully participated in a bid-defense; won the award for CAR-T therapy in allogenic stem cell transplant patients

Provided support and leadership to the Site Monitors on multiple clinical trials.

Conducted training teleconferences and supported training needs throughout all phases of the trial.

Planned and presented at Study Coordinator Trainings as a support to the Clinical Trial Team.

Ongoing review of monitoring visit reports with issue review, resolution and escalation as appropriate.

Developed training tools and guidance documents to support monitoring activities.

Developed and updated Case Report Form Completion Guidelines as needed.

Developed Site Monitoring Plans and updates as needed.

Timely distribution of communications to study team with follow-up as appropriate.

Mentor and Trainer to Monitors on the following:

• Therapeutic, protocol specific and general new hire training.
• Recruitment Initiative
• Audit Preparation
• Team Meeting Presentations

Technical Trainer Role:

• Conducted the integration of technical training for Monitors.
• Participated in the development of the Monitor Training program and development of the training manuals.
  

Committed and Initiative Involvement:

• Site Development Specialist
• Investigator Training Program - Trainer
• Patient Recruitment initiative
• Development of Site Management Model/Manual
• Development of Site Coordinator Training

• Enhanced patient care by effectively coordinating clinical team efforts and streamlining communication.
• Successfully managed complex cases by collaborating with physicians, nursing staff, and other healthcare professionals, ensuring optimal patient care delivery.
• Championed interdisciplinary collaboration between departments resulting in more comprehensive care plans for patients.
• Established a patient-centered care model within the clinical team, promoting positive relationships and open communication between staff and patients.

Successfully managed a variety of hematology oncology projects at the site level (SMO)

Selected to participate in a bid defense for CAR-T cell therapy study

Developed and implemented streamlined processes for study tracking (e.g., sample management)

• Coordinated with external research partners to ensure seamless integration of collaborative projects.
• Synthesized complex information into clear summaries to make findings accessible to diverse audiences.
• Contributed to development of research proposals, aligning with strategic objectives and securing project approvals.
• Enhanced participant recruitment strategies, leading to more diverse and representative study samples.

Managed the full service of clinical and operational delivery for the Multiple Sclerosis studies

• Cultivated productive working relationships with key opinion leaders in the field to enhance scientific credibility and promote trial awareness among stakeholders.
• Maximized participant retention rates through proactive identification of potential risk factors and implementation of effective mitigation strategies as needed throughout the course of the study.
• Supported timely patient enrollment by proactively addressing potential barriers and utilizing strategic communication methods.
• Streamlined clinical trial processes by implementing efficient data management systems and documentation practices.