Giri Prasad Venkiteela

I’m a Clinical Operations Leader with over 13 years of experience managing global clinical trials from First-in-Human through Phase III, primarily in oncology, infectious diseases, and rare conditions. I specialize in leading cross-functional teams, overseeing CROs and CRAs, and ensuring trials are delivered on time, within budget, and fully compliant with ICH-GCP. My work focuses on strategic planning, performance management, and driving operational excellence across all phases of clinical development.

Professional Experience

Clinical Operations Lead (Associate Director) – Global Clinical Operations (Aug 2024 – Apr 2025)
Senior Clinical Trial Manager (CTM) (Jan 2022 – Aug 2024)
Moderna Tx, Inc. – Remote
As Global Clinical Operations Lead for Moderna’s Infectious Disease therapeutic area, I spearheaded the strategic planning and hands-on execution of four complex global Phase I–III trials – including pivotal COVID-19 and Lyme disease vaccine studies. I oversaw trial delivery across North America, the U.K., and Asia-Pacific, ensuring programs were executed on time, within budget, and in full compliance with ICH-GCP, regional regulations, and internal SOPs.

Key Contributions & Achievements:

Study Oversight: Directed operational execution for 4 global studies spanning 5 countries and 450+ sites, consistently achieving >95% protocol compliance and ≥98% on-time delivery of critical milestones. Led two NDA-enabling pivotal trials, resulting in regulatory submissions with zero critical findings from major health authorities (FDA, Health Canada, EMA/MHRA, PMDA).

Team Leadership & Development: Managed and mentored a cross-functional clinical team of 5 CTMs and 4 CTAs, driving professional growth and maintaining a <5% turnover rate. Provided ongoing coaching, performance evaluations, and training opportunities to elevate team capabilities. Played a key role in recruiting and onboarding new clinical operations talent to scale program needs.

Budget & Vendor Management: Oversaw program budgets totaling $400M+, maintaining spend within 5% variance through robust forecasting and proactive risk mitigation. Led vendor oversight and contract negotiations with 2 major CROs, achieving ≥90% SLA adherence and >85% site satisfaction in post-activation surveys. Collaborated with CRO CRA managers to ensure optimal resourcing and monitoring quality, and designed targeted training programs for 100+ CRO team members to address performance gaps.

Site Engagement & Start-Up: Improved site activation timelines by 30% through refined site management organization (SMO) oversight and targeted investigator engagement strategies. Achieved 100% First-Patient-In on schedule across all studies, with >90% of sites meeting enrollment targets within expected timelines.

Quality & Inspection Readiness: Maintained 100% Trial Master File (TMF) completeness at study close-out via rigorous monthly QC reviews. Supported 3 internal audits and 2 regulatory inspections (FDA, PMDA) with no major findings. Ensured 100% team completion of GCP and study-specific training prior to site activations, strengthening inspection readiness.

Monitoring Excellence & Metrics: Established a comprehensive CRA performance metrics program (tracking trip report turnaround, query resolution, data entry currency) by leveraging new analytics tools for continuous improvement. This initiative improved CRA monitoring efficiency and data quality, reducing open query backlog by 20% and speeding up issue resolution times. Additionally, implemented digital dashboards and centralized issue-tracking, cutting issue resolution timelines to under 10 business days and enabling proactive risk management.

Stakeholder & Investigator Relations: Built strong partnerships across 450+ global sites. Hosted bi-monthly Principal Investigator webinars and led two international investigator meetings to maintain engagement and momentum. These efforts boosted investigator satisfaction scores by 20% year-over-year (per annual survey feedback).

Strategic Impact: Contributed to therapeutic-area level portfolio planning by providing real-time operational data and insights. Influenced key program decisions and adaptations (e.g., protocol adjustments, resource reallocations) that improved study feasibility and alignment with corporate strategy.

Clinical Trial Manager (CTM) – Global Phase II/III Trials (Dec 2020 – Jan 2022)
PPD, Inc. – Remote

Led end-to-end clinical trial operations for multiple Phase II–III global studies from start-up through close-out, ensuring 100% on-time delivery of key milestones across CNS, infectious disease, oncology/hematology, and rare disease programs.

Oversaw cross-functional collaboration with 10+ internal departments and 5+ external vendors, maintaining proactive sponsor communication and 95%+ adherence to timeline, quality, and budget expectations.

Acted as the primary client liaison for sponsor communications, fostering strong relationships that led to repeat project awards and consistently high sponsor satisfaction. Successfully led 3 cross-functional project teams (including subcontractors and partner CROs) to coordinated delivery.

CRA Team Oversight: Provided oversight and mentoring to CRA teams across all assigned studies. Conducted co-monitoring visits and regular quality reviews of monitoring reports, ensuring consistent adherence to monitoring plans, GCP guidelines, and high data quality across 75+ sites.

Managed operational risk assessments and mitigation plans, reporting to senior leadership and reducing protocol deviations by 30% through early intervention strategies and corrective action plans.

Streamlined investigator recruitment and site selection, accelerating site activation by 25% and contributing to >90% of sites meeting enrollment targets.

Maintained an audit-ready TMF with an 85% QC pass rate. Supported 2 successful regulatory inspections and multiple sponsor audits with no critical findings.

Provided ongoing oversight of clinical vendors and consultants: tracked study KPIs (enrollment, data entry, query resolution), proactively escalated issues, and forecasted IMP and clinical supply needs to prevent delays.

Senior CRA / Lead CRA (Jun 2018 – Dec 2020)
PPD, Inc. – Remote

Served as Lead CRA, supporting the CTM and Clinical Operations Lead by overseeing site performance and mentoring a team of junior CRAs – efforts that led to a promotion into the CTM role.

Independently managed monitoring activities across 15+ sites for Phase II–III oncology and infectious disease trials, ensuring 100% adherence to ICH-GCP and all protocol requirements.

Conducted 250+ site visits (initiation, routine monitoring, and close-out), providing timely follow-up, issue resolution, and on-site training. Achieved >95% site compliance with study procedures and minimized data queries through diligent source data verification.

Collaborated with cross-functional teams to support study start-up activities, including regulatory document submissions, EC/IRB approvals, and contract execution – contributing to on-time activation of >90% of sites.

Oversaw investigational product (IP) accountability and maintained complete Investigator Site Files (ISFs) at each site, ensuring all essential documents and drug supply records were audit-ready and compliant.

CRA I / II / III (Oct 2012 – Jun 2018)
Prowess CRO Solutions (contracted to AbbVie) – Remote
Progressed from CRA I to CRA III over five years through strong performance, attention to detail, and dedication to site management excellence. Gained broad monitoring experience across 100+ sites and numerous therapeutic areas (Oncology, Dermatology, Neurology, Infectious Disease, etc.), supporting global Phase I–III trials.

Supported study start-up and feasibility as a CRA I by managing CDAs, site questionnaires, site identification, and pre-study qualification visits – contributing to a >90% accuracy in selecting high-performing sites.

Coordinated the preparation and collection of essential regulatory documents, IRB/EC submissions, and site contracts, facilitating on-time activation for 100+ sites across multiple studies.

Progressed to full monitoring responsibilities, conducting 600+ site visits (initiation, monitoring, close-out) across 75+ investigator sites. Ensured >95% adherence to GCP and protocol standards through rigorous oversight and site coaching.

Maintained strong site relationships and proactively resolved site-level issues, resulting in ≥90% of sites meeting or exceeding enrollment targets within planned timelines.

Performed comprehensive source data verification and query management, contributing to clean data lock and a 25% reduction in data entry timelines.

Ensured 100% compliance in site documentation and record-keeping (ISF maintenance, protocol deviation logs, essential documents), leading to audit-ready sites with no documentation findings.

Oversaw investigational product handling at sites (shipment tracking, accountability logs, reconciliation), helping reduce IP-related deviations by >30%.

Provided ongoing training and re-training to site staff on protocol procedures, informed consent, and GCP, which improved site audit readiness scores.

Identified site performance trends and early warning signs of issues, escalating to CTM/PM as needed and contributing to CAPA development and follow-up.

Coordinated with central laboratories and eClinical vendors (e.g., ePRO, IRT systems) to ensure smooth data flow and logistics for sites across North America.

Recognized frequently by CTMs and sponsors for proactive communication and timely follow-up, improving overall monitoring efficiency in assigned regions.

Mentored new CRA hires (as a CRA II/III), sharing best practices and promoting consistent monitoring approaches across projects.

Regulatory Affairs Associate (Mar 2012 – Sep 2012)
Prowess CRO Solutions – Glasgow, UK

Supported regulatory submissions (IMPD/IND/CTA packages) by preparing, reviewing, and tracking documents to ensure compliance with global regulatory guidelines and timelines. Coordinated communication between project teams and regulatory authorities, contributing to successful clinical trial application approvals.

Data Management Associate (Nov 2010 – Mar 2012)
Prowess CRO Solutions – Glasgow, UK

Assisted in Case Report Form (CRF) design, query resolution, and clinical database setup. Worked closely with biostatisticians and data managers to maintain data integrity and support timely database locks for multiple Phase II–III studies.

Therapeutic Areas of Experience

Oncology/Hematology: Acute Myeloid Leukemia (Phase II–III), Myelodysplastic Syndromes (Phase II–III), Non–Small Cell Lung Cancer (Phase III)

Infectious Diseases: HIV (Phase III), COVID-19 (Phase I–III), Lyme Disease (Phase I–II)

Central Nervous System: Duchenne Muscular Dystrophy (Phase I–III, incl. open-label extension), Parkinson’s Disease (Phase II), Alzheimer’s Disease (Phase II–III)

Rare Diseases: BK Virus in Kidney Transplant Recipients (Phase II), Duchenne Muscular Dystrophy (Phase II–III)

Cardiovascular: Heart Failure, Hypertension (Phase II–III)

Ophthalmology: Macular Edema, Macular Degeneration (Phase III)

Dermatology: Atopic Dermatitis (Phase II), Psoriasis (Phase III)

Systems & Tools Proficiency

Clinical Trial Systems: Medidata, Veeva & Oracle CTMS; Medidata Rave, Veeva EDC & Oracle Inform (EDC); Phlexglobal & Veeva Vault eTMF; IRT/IVRS (Endpoint, Almac, Signant)
Data & Analytics: Tableau, Power BI, Spotfire – creating dashboards and visualizations for trial metrics
Productivity & Collaboration: MS Teams, SharePoint, Slack, Outlook; Smartsheet, MS Project (Gantt) for project tracking; Microsoft Office Suite (Excel, Word, PowerPoint)
Quality/Training Systems: Cornerstone & ComplianceWire LMS; Inspection readiness tools; Capable of leveraging new technology platforms for monitoring efficiency
Other: Workday (HRIS for time tracking/performance management); Concur (expense reporting)

I hold a Master of Science in Pharmaceutical Analysis and Quality Management from the University of Strathclyde in Glasgow, Scotland. Additionally, I’ve completed two graduate certificates from Humber College in Ontario, Canada—one in Project Management and another in Regulatory Affairs. My foundational education includes a Bachelor of Pharmacy from Jawaharlal Nehru Technological University in India. This combination of scientific, regulatory, and project management training has equipped me with a well-rounded perspective to lead complex clinical programs effectively.