Pinky Patel

• Project Leadership: Spearheaded a global initiative aimed at combating tuberculosis in developing nations, overseeing and optimizing the execution of clinical trials. Guided a team of clinical operations professionals while collaborating with cross-functional teams to ensure the successful delivery of clinical projects within defined scope, timelines, and budgets.
• Regulatory Management: Directed the management of regulatory submissions to various national and international health authorities, including the Ministry of Health, SAPHRA, BPOM, and other regulatory bodies, ensuring compliance with all applicable standards.
• Study Development: Developed comprehensive study plans encompassing monitoring, statistical analysis, data management, and clinical operations. Created essential guidance documents and trackers for study start-up, closeout, payments, budgets, contracts, and recruitment tracking.
• Document Contribution: Played a pivotal role in crafting key study-related documents, including protocols, Investigator’s Brochures (IB), lab manuals, informed consent forms (ICFs), and promotional materials to support recruitment efforts.
• Vendor and Site Management: Led vendor engagement and site management by aligning team efforts with study goals, outcomes, and budgetary constraints, ensuring strong performance and timely delivery.
• Partnership Cultivation: Fostered and maintained robust partnerships domestically and internationally with external researchers, key opinion leaders, vendors, and study sites, facilitating effective collaboration and communication.
• Subject Safety and Compliance: Prioritized participant safety and adherence to clinical protocols and Good Clinical Practice (GCP) standards, utilizing medical monitoring to uphold these principles.
• Data Interpretation and Reporting: Analyzed clinical data to author comprehensive Clinical Study Reports (CSRs), incorporating insights from various stakeholders, vendors, and departments to ensure accuracy and clarity.
• Publication Strategy Support: Contributed to the strategic planning of clinical data dissemination, preparing and submitting study findings to leading scientific journals and conferences for publication.
• Regulatory Strategy Leadership: Directed clinical strategy for regulatory submissions, effectively responding to inquiries from regulatory bodies and presenting findings at official regulatory meetings.

• COVID Study Leadership: Contributed to global, multiphase clinical studies for both adult and pediatric populations, as well as a dose modification study focused on COVID-19.
• Scope and Budget Management: Developed and managed the scope and budget at the program level, including the creation and oversight of Requests for Proposals (RFPs), Statements of Work (SOWs), and resource allocations.
• Strategic Program Management: Provided strategic oversight of COVID programs, guiding clinical study execution from initial study design and protocol development through the completion of final study reports and regulatory filings.
• Investigator and Site Engagement: Actively participated in investigator and site selection, recruitment, and training. Fostered strong relationships with investigators and study sites throughout the trial process.
• Stakeholder Presentations: Planned and developed written and oral presentations of clinical study information, participating in Investigator’s Meetings and reporting key results, risks, and milestones to senior leadership as required.
• Cross-Functional Collaboration: Collaborated effectively with Research & Development, Quality Assurance, Clinical Operations, Regulatory Affairs, and other departments on clinical management, protocol enhancements, budget and contract negotiations, issue resolution, and document submissions.
• Risk Management and Feedback: Provided qualitative and quantitative feedback on trial execution, including risk assessments and mitigation plans, to senior stakeholders, key opinion leaders (KOLs), review committees, and internal team members.
• Regulatory Submission Support: Assisted in the preparation of regulatory submissions, including INDs, NDAs, IDEs, PMAs, and PMA supplements, ensuring thorough documentation and compliance with regulatory standards.
• Data Management Collaboration: Partnered with Data Management and Biostatistics teams to ensure that clinical studies were effectively planned, executed, and analyzed.
• Vendor Management: Recruited and managed vendors, ensuring that clinical study requirements and milestones were met.
• Team Leadership: Managed a diverse clinical research team, including Clinical Trial Managers and interns, focusing on professional development and performance enhancement.
• Cross-Functional Strategy Development: Collaborated with cross-functional teams, including R&D, Marketing, and Quality Assurance, to define, implement, and execute global clinical strategies aligned with business objectives.
• Clinical Activities Planning and Execution: Planned, developed, and executed various clinical activities (e.g., studies, surveys, committees) to ensure all deliverables were achieved on time and within budgetary constraints.
• Documentation Development: Drafted and refined clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other essential clinical study documents to meet regulatory requirements.
• Regulatory Documentation Review: Developed and reviewed essential clinical documentation such as Clinical Study Reports (CSRs), Post-Market Clinical Follow-Up (PMCF) Reports, and Clinical Evaluation Reports (CERs) for regulatory submissions.
• Site and KOL Interaction: Engaged with investigational sites, vendors, KOLs, and consultants to facilitate smooth study execution and foster collaboration.
• Clinical Monitoring Activities: Conducted on-site clinical monitoring activities as necessary to ensure compliance and address any issues promptly.
• Adverse Event Reporting: Collaborated with Medical Monitors, Regulatory Affairs, Clinical Operations, and Field Assurance teams to ensure timely reporting of Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Device Events (UADEs).
• Compliance Oversight: Led clinical projects to ensure compliance with study protocols, corporate standards, regulations, and Good Clinical Practice (GCP) guidelines.
• Post-Market Activities Leadership: Managed sustaining clinical activities for post-market product registrations in a $2 billion revenue-generating Business Unit, ensuring ongoing compliance and support.
• Subject Matter Expert Participation: Served as a subject matter expert on cross-functional project teams, providing expertise in clinical and regulatory strategies.
• Standardized Process Development: Developed standardized processes and procedures for Clinical and Medical Affairs to enhance operational efficiency.
• Global Product Registration Achievements: Played a key role in multiple successful global product registrations for regulatory bodies including Australia (TGA), Japan (PMDA), China (NMPA), Canada (Health Canada), the European Union (MDD and MDR), and the USA (FDA).
• Consultation on New Product Development: Provided consultation on clinical and regulatory submission strategies for New Product Development (NPD) and post-market surveillance product lifecycle compliance.
• Committee Management: Managed Clinical Event Committees (CEC) and Data Monitoring Committees (DMC)/Data Safety Monitoring Boards (DSMB) to ensure rigorous oversight of clinical trials.

• Project Planning and Implementation: Directed project planning, scheduling, and implementation, defining project scope, resource requirements, and deliverables. Developed and maintained comprehensive cross-functional project management plans, while overseeing budgets (overall, vendor, site, ancillary) and timelines (overall, study start-up, recruitment, data locks).
• Study Startup Oversight: Oversaw all study start-up activities, leading the evaluation, feasibility, and selection of investigative sites. Managed the establishment of portals, systems, and databases, and developed initial project plans.
• Vendor and CRO Management: Participated in the selection and maintenance of vendors and Contract Research Organizations (CROs). Coordinated and monitored activities, ensuring effective management of timelines and budgets, including addressing performance issues through the development and monitoring of corrective action plans.
• Study Closeout Activities: Ensured all closeout and post-closeout activities were completed, including data review, Trial Master File (TMF) finalization, database lock (DBL) management for global teams, vendor reconciliation, and contributions to Clinical Study Reports (CSRs).
• Integrity and Compliance: Maintained the highest integrity in study execution by monitoring safety, protocol deviations (PDs), query entries (QEs), and ensuring compliance with GCP, ICH, and other regulations and policies.
• Audit and Compliance Responsibilities: Managed audit reviews and Corrective and Preventive Actions (CAPA) resolution. Presented at bid defenses and ensured accuracy in contracts and budget modifications, while collaborating with finance on purchase orders and contract updates.
• Tracking and Reporting: Tracked and reported timelines, budgets, and other study metrics using dashboards and trackers. Worked cross-functionally to align clinical study timelines and goals, effectively escalating or mitigating risks.
• Stakeholder Communication: Prepared and presented updates on study progress for stakeholders, committees, and internal teams, ensuring transparent communication of timelines and performance.
• Study Documentation Development: Prepared, reviewed, and approved study plans (internal and external) and essential study materials such as CRFs, ICFs, drug accountability forms, study manuals, and monitoring documents.
• Clinical Trial Management System (CTMS): Set up and managed CTMS, portals, and trackers for the company and external vendors to optimize project tracking and data management.
• Team Development and Mentorship: Built and developed clinical, regulatory, and Quality Assurance (QA) teams in the US office. Established a leadership structure, budget, induction and onboarding processes, and ongoing training programs, all in alignment with GCP/ICH guidelines.
• Quality Assurance Procedures: Established departmental quality assurance procedures, including SOPs, policies, templates, and working documents to ensure compliance and operational excellence.
• Leadership and Team Management: Managed and mentored a multi-national team of direct reports, fostering professional growth and development within the team structure.
• Women’s Health Studies: Contributed to the planning and execution of women's health studies, aligning research efforts with organizational goals and addressing critical health needs.
• Cross-Functional Strategy Collaboration: Planned and strategized with R&D, Marketing, Quality, and other business partners to define, implement, and execute global clinical strategies supporting the organization’s objectives.
• Clinical Activities Execution: Planned, developed, and executed clinical activities (e.g., studies, surveys, committees) to ensure timely and budget-compliant deliverables.
• Clinical Documentation Development: Developed clinical study protocols, ICFs, CRFs, and other essential documentation, ensuring thorough preparation for regulatory submissions.
• Regulatory Submission Support: Developed and reviewed clinical documentation (e.g., CSR, PMCF Report, CER) to support regulatory submissions and compliance.
• Site and KOL Interaction: Engaged proactively with investigational sites, vendors, key opinion leaders (KOLs), and consultants to facilitate smooth study operations.
• On-Site Monitoring: Conducted on-site clinical monitoring activities as necessary to ensure adherence to study protocols and compliance with regulatory guidelines.
• Adverse Event Reporting Collaboration: Worked collaboratively with Medical Monitors, Regulatory Affairs, Clinical Operations, and Field Assurance to ensure timely reporting of Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Device Events (UADEs).
• Clinical Research Direction: Directed and implemented clinical research plans and programs according to established design principles and integrated Clinical Development Plans (CDP) and Development Plans (DDP).
• Research Project Participation: Actively participated in both internal and joint internal/external research project teams related to new compound development and further studies of marketed compounds.
• Clinical Finding Analysis: Analyzed and summarized clinical findings from studies to support safety and efficacy decision-making for new drug applications, clinical study reports, and publications.
• Protocol Development Leadership: Led the development of clinical protocols aligned with CDP objectives and planned clinical trials, operational plans, and settings based on clinical development strategies.

Global Project Manager: Jan 2015-May 2017

• Operational and Financial Management: Oversee the operational and financial aspects of clinical studies on a global scale, managing projects from initiation through the closeout phase to ensure successful delivery.
• Site and Vendor Selection: Actively participate in the selection of investigative sites and vendors to align capabilities with study requirements and objectives.
• Vendor and Department Oversight: Manage multiple vendors and departments, ensuring coordination and efficient communication to achieve project goals.
• Trial Master File (TMF) Management: Develop and implement the TMF Management Plan, ensuring the quality, completeness, and regulatory compliance of the TMF throughout the study lifecycle.
• Budget Management: Maintain and manage study budgets proactively, ensuring alignment with study objectives while monitoring for cost efficiency.
• Risk Mitigation and Contingency Planning: Develop contingency plans and proactively identify issues to mitigate risks throughout the clinical study process.
• Audit Management: Address internal and external audit findings effectively, ensuring compliance with GCP, relevant SOPs, and regional regulatory requirements.
• Study and Site Start-Up Activities: Oversee global start-up activities, including document development, vendor and site selection, as well as managing contracts and budgets.
• Project Planning and Implementation: Oversee the development and implementation of comprehensive project plans that guide study execution.
• Project Management Reporting: Prepare detailed project management reports for clients and management to track progress and ensure transparent communication.
• Staff Direction and Resource Management: Direct the activities of assigned project support staff by implementing resource strategies to achieve project objectives effectively.
• Collaboration and Consistency: Collaborate with other Project Managers across the program to ensure consistency in study approach and methodologies.
• Performance Management: Manage line responsibilities, including performance reviews, resource allocation, and oversight of quality and deliverables.
• International Experience: Successfully executed OA trials across North America, Latin America, Europe, and Asia Pacific regions, demonstrating strong global coordination capabilities.
• Team Leadership in Oncology Trials: Directed a team of 15 CRAs for the management of over 10 oncology trials, resulting in a 25% increase in patient enrollment over a two-year period.
• Operational Improvements: Implemented strategic operational improvements that reduced study timelines by an average of 15%, significantly expediting drug development processes.
• Enhanced Compliance: Achieved a 30% increase in site compliance with protocol and regulatory requirements through the establishment of rigorous training programs and quality control measures.
• Cross-Functional Collaboration: Initiated collaborations with laboratory services for precision medicine studies, aligning clinical objectives with patient-centric outcomes.
• Global Protocol Design Contribution: Key contributor to the design of global trial protocols, integrating innovative methodologies that facilitated patient recruitment and retention in rare disease research.
• Proactive Budget and Resource Management: Managed study budgets and resource allocation proactively to prevent cost overruns across concurrent clinical trials.

Sr. Clinical Monitoring Project Lead: Aug 2014-Jan 2015

• Team Leadership: Lead a team of Project Leads across multiple regions to ensure program and study consistency, fostering collaboration and alignment among global clinical monitoring teams.
• Quality Assurance: Ensure the quality of clinical monitoring deliverables within the project by implementing effective tracking tools to maintain visibility of progress and identify any potential issues promptly.
• Report Review and Compliance: Review clinical monitoring reports within SOP-mandated timelines, ensuring adherence to monitoring plans and regulatory requirements for high-quality data reporting.
• Workload and Site Management: Allocate workload and site assignments among the clinical monitoring team, optimizing resource utilization and team efficiency.
• Information Dissemination: Ensure efficient dissemination of critical information across the Clinical Research Associate (CRA) team to maintain clarity and direction in project execution.
• Budget Alignment: Verify that clinical activities align with budget constraints, supporting financial accountability and responsible resource management.
• Direct Reports Management: Manage and mentor direct reports, providing guidance and support to enhance team performance and professional development.
• Study Materials Development: Support the development of study-related materials, presenting them effectively at investigator or study launch meetings to ensure clarity and buy-in from all stakeholders.
• CRA Training and Development: Create and deliver project-level CRA training sessions, covering topics such as clinical monitoring plans, clinical monitoring aids, and annotated visit reports, to enhance the competencies and effectiveness of the monitoring team.

Associate Clinical Trial Manager: Feb 2013-Jul 2014

• Protocol Execution Management: Oversee the execution of clinical trial protocols, managing all operational aspects from start-up through close-out while adhering to Standard Operating Procedures (SOPs) and ensuring compliance with country regulations and ICH/GCP guidelines.
• CRO Interaction Oversight: Manage interactions with Contract Research Organizations (CROs), providing oversight for operational functional activities such as study management, site monitoring, and site management to ensure alignment with project objectives.
• Vendor Leadership: Serve as the vendor lead, taking responsibility for risk management and the development of mitigation plans to address potential operational challenges.
• Document Development Assistance: Assist in the creation of essential internal and external study documents, including clinical monitoring and management plans, Team Charters, TMF management plans, protocols for deviation handling, screening/enrollment closure procedures, and pharmacy manuals.
• Study Status Reporting: Prepare comprehensive study status metrics and risk mitigation reports for presentation to senior management, ensuring clear communication of project progress and challenges.
• Risk Identification and Mitigation: Proactively identify potential study risks, recommending appropriate mitigation strategies and facilitating discussions to implement solutions effectively.
• Quality Data Management: Participate in ensuring quality clinical data review processes and uphold data integrity for assigned clinical trials, contributing to the accuracy and reliability of trial outcomes.
• Inspection Readiness: Ensure that clinical trial sites are always inspection-ready, participating in Quality Assurance and/or regulatory authority inspections and audits as needed, to maintain compliance.
• CRA Management: Directly manage Clinical Research Associates (CRAs), providing leadership and support to ensure effective monitoring and adherence to study protocols.

Sr. Lead CRA: May 2012-Feb 2013

• Clinical Trial Implementation and Monitoring: Implement and monitor clinical trials to ensure that both sponsor and investigator obligations are met, maintaining compliance with applicable local regulatory requirements and GCP guidelines.
• Site File and Data Reconciliation: Conduct thorough investigative site file reconciliation, investigational product (IP) reconciliation, and source data verification (SDV), utilizing centralized monitoring techniques in accordance with local regulatory requirements, GCP guidelines, project Standard Operating Procedures (SOPs), and sponsor mandates.
• Study Development and Start-Up Participation: Actively participate in the study development and start-up process, including protocol review, case report form (CRF) design and review, preparation of Informed Consent Forms (ICFs), and development of study documents. Engage in clinical training programs and maintain current knowledge in clinical research developments.
• Serious Adverse Event (SAE) Reconciliation: Reconcile serious adverse events against clinical data listings to ensure accurate reporting and compliance with safety regulations.
• Mentorship and Training: Mentor junior-level CRAs and serve as a knowledgeable resource for new team members, enhancing team competency and performance.
• Therapeutic Area Experience: Gained extensive experience in conducting oncology, endocrinology, and nephrology trials, contributing to a diverse range of clinical research projects.
• Site Activation Oversight: Successfully oversaw the activation of over 20 clinical trial sites within a 12-month period, ensuring compliance with GCP and ethical standards.
• Data Quality Enhancement: Monitored clinical study sites to identify and resolve issues, resulting in a noteworthy 15% improvement in data quality.
• Risk Mitigation Development: Played a critical role in developing risk mitigation strategies that led to a 40% reduction in audit findings, enhancing overall study compliance and efficiency.
• eTMF Documentation Management: Managed electronic Trial Master File (eTMF) documentation, achieving 95% completeness and accuracy in preparation for FDA inspections, thereby ensuring regulatory readiness.
• Relationship Building: Fostered strong relationships with site personnel and internal team members, enhancing communication and accelerating study progress.

• Project Management Leadership: Manage all aspects of large-scale clinical research projects, supporting the clinical team in achieving on-time and on-budget performance while ensuring adherence to project goals.
• Team Supervision and Mentorship: Supervise, train, and mentor junior staff members, fostering their professional development while managing various vendors to guarantee high-quality deliverables.
• Regulatory Document Oversight: Review and approve regulatory and administrative documents from investigative sites, preparing and submitting necessary regulatory documents to Institutional Review Boards (IRBs) and addressing any queries raised.
• SAE Report Management: Assist in the preparation and review of Serious Adverse Event (SAE) reports to ensure accurate documentation and compliance.
• Project Reporting: Prepare comprehensive project management reports for clients, project personnel, and pharmaceutical management, facilitating clear communication regarding project status and updates.
• Monitoring Report Development: Develop, review, and approve monitoring trip reports, ensuring thorough documentation of site visits and observations.
• Data Oversight: Review tables and listings generated from study data to ensure accuracy and compliance with study protocols.
• Monitoring Tools Creation: Author monitoring tools and help aids to enhance CRAs’ efficiency in conducting site visits and monitoring activities.
• Study Lifecycle Management: Track and expedite study startup, maintenance, and close-out activities in the U.S. while overseeing activities occurring in other countries.
• CRA Training: Train Clinical Research Associates (CRAs) on study specifics, internal procedures, and query resolution, enhancing their effectiveness in monitoring activities.
• Co-Monitoring Responsibilities: Co-monitor with CRAs to ensure compliance with GCP guidelines as per company and client Standard Operating Procedures (SOPs).
• Diverse Therapeutic Areas: Contributed to studies across diverse therapeutic areas, including oncology, asthma, allergy, cardiovascular, hematology, infectious diseases, Alzheimer’s, and rheumatology.
• Site Visits Management: Conduct site qualification, initiation, interim monitoring, and close-out visits—both on-site and remotely—ensuring compliance with regulatory, ICH-GCP, and protocol standards.
• Site Performance Evaluation: Assess overall site performance and staff effectiveness, providing actionable recommendations and escalating critical issues to the project team as needed.
• Informed Consent Verification: Ensure the informed consent process is conducted properly, assessing factors affecting patient safety and data integrity, including protocol deviations and pharmacovigilance issues.
• IP Management: Oversee investigational product (IP) inventory and reconciliation, ensuring compliance with protocol requirements regarding dispensing and administration.
• Investigator Site File (ISF) Review: Review the ISF for accuracy and completeness, reconciling it with the Trial Master File (TMF) and ensuring proper archiving of essential documents.
• Documentation and Tracking: Document project activities through confirmation letters, trip reports, and communication logs as per SOPs, supporting subject recruitment, retention, and awareness efforts.
• Liaison Role: Act as a primary liaison with study site personnel, ensuring compliance with regulatory and project-specific training requirements.
• Meeting Preparation: Prepare for and lead Investigator Meetings and sponsor presentations, ensuring effective communication and clarity of project goals.
• Audit Readiness Guidance: Provide guidance on audit readiness standards, supporting preparation for audits and necessary follow-up actions post-audit.
• CRA Leadership and Mentorship: Provide direct supervision and mentorship to junior CRAs, including training and sign-off visits as assigned.
• Business Development Participation: Participate in business development proposals and defense meetings under the supervision of an experienced Clinical Operations Lead or operational line manager.

• Study Document Development: Create and develop critical study-related documents to ensure the effective execution of clinical trials for both monitors and sites. This includes crafting monitoring plans, manuals of operations, Serious Adverse Event (SAE) reporting guidelines, monitoring tools, report templates, case report form (CRF) completion instructions, and CRF development, all in accordance with SOPs, GCP, and FDA guidelines.
• Site Visit Management: Conduct comprehensive site visits, encompassing initiation, monitoring, and close-out activities. This includes electronic CRF review and site training to ensure site personnel are fully equipped to meet study requirements.
• SAE Reporting Procedures Implementation: Spearhead the implementation of new procedures for receiving and reviewing Serious Adverse Events (SAEs) in-house, enhancing the efficiency and accuracy of safety reporting.
• Therapeutic Area Expertise: Contributed significantly to the management of clinical trials in cardiovascular and urology studies, leveraging specialized knowledge to improve study outcomes and compliance.

• Site Visit Execution: Conduct periodic site visits to initiate, monitor, and close out clinical research sites, ensuring thorough oversight throughout the study lifecycle.
• Compliance Management: Oversee site management to ensure compliance with study protocols and adherence to Institutional Review Board (IRB) guidelines, Good Clinical Practice (GCP), and FDA regulations, maintaining the integrity of the clinical trial process.
• Study Start-Up and Termination Management: Manage all aspects of study start-up and termination tasks as specified by sponsors and internal SOPs. Key activities include developing monitoring tools, writing case report forms (CRFs), resolving queries, conducting data listing audits, and addressing both in-house regulatory and site audit findings.
• Therapeutic Area Focus: Gained experience in conducting Phase 2 and open-label extension studies within Pain Management, with a specific focus on Rheumatoid Arthritis, contributing to advancements in treatment and patient care.

• In-House Monitoring Coordination: Coordinate and perform in-house monitoring activities related to the conduct of clinical trials, ensuring that all operations align with study protocols and regulatory requirements.
• Regulatory Documentation Management: Provide technical services for the collection, review, maintenance, and tracking of regulatory documentation in databases and Central Files for Phase II and III studies, ensuring that all records are current and compliant.
• Regulatory Compliance Assurance: Ensure strict compliance with FDA regulations pertaining to Good Clinical Practice (GCP) guidelines and Standard Operating Procedures (SOPs), thereby safeguarding the integrity of clinical data and participant safety.
• Progression Reporting: Compile and deliver monthly reports on the progression of studies for various sponsor companies, facilitating transparent communication and informed decision-making.
• Budget Tracking and Investigator Payment Coordination: Maintain efficient tracking of study budgets and coordinate investigator payments on a monthly basis, ensuring timely compensation and adherence to financial agreements.