Summary
Overview
Work History
Education
Skills
Personal Information
Languages
Therapeutic Areas Of Expertise
Key Highlights
Timeline
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Siva Kumar Pannem

Menifee,USA

Summary

Passionate clinical research professional with over 20 years of experience in clinical research industry managing successful clinical trials across various therapeutic areas such as oncology, Pulmonology, Diabetes, Cardiology, Urology, Neuro Oncology, infectious diseases, CINV, Hepatitis -C, Psychiatry, Hepatitis B Vaccine study, HIV Vaccine studies, Breast Cancer, Ovarian Cancer, Asthma, Dermatology, Psoriasis, rheumatology etc. Supported and supervised all aspects of the project lifecycle, including site management and clinical operations, and ensures regulatory compliance with FDA regulations and ICH guidelines. Spearheaded clinical research projects, collaborating with multiple interdisciplinary stakeholders across multiple departments to ensure timely completion and adherence to budgetary constraints. Strategic communication, collaboration, analytical thinking, and interpersonal skills to collaborate with stakeholders, sponsors, and external partners.

Overview

20
20
years of professional experience

Work History

Associate Clinical Operations Leader

PREXEL International
Menifee, USA
02.2022 - Current
  • Experience in managing the clinical research studies from startup phase to close out phase.
  • Successfully led multiple clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements.
  • Implemented risk management strategies to mitigate potential issues and ensure smooth study progression.
  • Developed and maintained strong relationships with key stakeholders, including sponsors, investigators, and regulatory authorities.
  • Managed Pulmonology, Oncology studies as ACOL.
  • Oversaw the execution of complex clinical trials in Pulmonology and Oncology, ensuring high-quality data collection and compliance with study protocols.
  • Coordinated with cross-functional teams to streamline study processes and enhance operational efficiency.
  • Currently managing an Ophthalmology study (Neovascular Age-Related Macular Degeneration) study in the USA across 118 sites along with another COL for NA region.
  • Spearheaded the management of a large-scale Ophthalmology study, collaborating with 118 sites across the USA.
  • Provided strategic oversight and guidance to ensure the successful execution of the study, meeting all milestones and deliverables.
  • Overall Project Management in coordination with sponsors and study vendors.
  • Led project management activities, including planning, execution, and monitoring of clinical trials.
  • Coordinated with sponsors and study vendors to ensure alignment on project goals and deliverables.
  • Prepares the project status updates to present to sponsor in weekly meetings.
  • Compiled and presented comprehensive project status updates to sponsors, highlighting key achievements, challenges, and mitigation strategies.
  • Facilitated effective communication and collaboration between project teams and sponsors.
  • Train the CRAs. Review visit reports.
  • Conducted training sessions for Clinical Research Associates (CRAs) to ensure they are well-equipped to perform their roles effectively.
  • Reviewed visit reports to ensure accuracy, completeness, and compliance with regulatory requirements.

Sr Clinical Research Associate

PAREXEL INTERNATIONAL
San Diego, USA
12.2009 - 02.2022
  • A self-motivated Sr. CRA, demonstrated detailed understanding of clinical trial management with high successful track record of 13 years of experience in clinical research industry.
  • Experience in managing the clinical research studies from startup phase to close out phase.
  • Achieved multiple recognitions across the projects.
  • Managed 2 projects at a time with 16 + sites with 5 onsite visits a month at minimum to meet metrics.
  • Assisted Line Manager with training and assessment visits for junior Clinical Research Associates (CRAs).
  • Conducted an average of 2-3 Assessment visits per year for junior CRAs.
  • Faced sponsor Audit at 2 site with only 3-4 minor findings.
  • Coached, mentored, and trained new hires CRA team members on study-specific protocols and procedures.
  • Conducted on-site and remote visits in adherence to the monitoring plan, ensuring compliance with protocol and regulations.
  • Submitted reports on time with more than 98% compliance in report submission and finalization with first time quality.
  • Resolved/closed site issues timely within 30 days to be compliant with company SOPs.
  • Resolved issues at sites by identifying potential deficiencies in documentation, communication, and training, resulting in a 20% reduction in errors.
  • Cultivated and maintained positive relationships with investigators and site staff, increasing the study recruitment and retention by 25%.
  • Promptly escalated sites with low enrollment and/or study issues to the Functional Lead (FL) and proposed effective solutions which resulted in a 100% resolution rate within established timelines.

Senior Clinical Research Associate

PAREXEL INTERNATIONAL
Bengaluru, India
11.2011 - 01.2016
  • Trained and guided new /trainee CRA team members to ensure study-specific knowledge transfer and proficiency in conducting clinical trials.
  • Managed and coordinated multiple complex projects as an independent Clinical Research Associate (CRA).
  • Conduct regular reviews to identify missing Serious Adverse Events (SAEs), Adverse Events (AEs), and Concomitant Medications data.
  • Collaborated with sites to establish recruitment plans during Qualification Visits, resulting in a 50% increase in patient enrollment rates.
  • Continuously followed up and updated plans during Initiation and Monitoring Visits, resulting in a 20% reduction in recruitment timeline and an overall 90% retention rate for enrolled patients.

Clinical Research Associate II

PAREXEL INTERNATIONAL
Bengaluru, India
12.2009 - 10.2011
  • Conducted clinical trials monitoring, site evaluation and initiation, data collection, drug accountability, and quality control review of data collected at trial sites to ensure compliance with the study protocol, local regulations, and ICH- GCP guidelines.
  • Demonstrated a high degree of proficiency and autonomy in meeting the requirements of a CRA II, resulting in the successful delivery of multiple clinical trials within timelines and budget.
  • Spearheaded regular communication with the clinical operation leader and manager and delivered timely updates on work progress and any issues, ensuring transparency, and avoiding surprises.

Sr. Clinical Research Associate

Global Hospitals
Hyderabad, India
07.2008 - 11.2009
  • The responsibility includes ensuring that the study is conducted as per ICH - GCP guidelines and also the study protocol, SOPs and other regulatory requirements, to counsel and recruit study participants.
  • Maintenance of trial site files (patient screening log, patient enrollment log, adverse event tracking log etc.), reporting the SAE/AE to the IRB and the Sponsor as per the timelines.
  • Training the site staff on Protocol and SOP's, write SOP's, resolve data discrepancies.
  • Work allocation to staffs for different projects, Quality check at the site.
  • Frequent Internal Monitoring.
  • Primary contact for all CROs and Sponsor Representatives for new studies till SIV.

Clinical Research Associate

Asian Clinical Trials Ltd
Hyderabad, India
04.2006 - 06.2008
  • Identification of potential investigators and clinical sites, both nationally and internationally; conducts pre-study site visits.
  • Participates in the final selection of investigators and study sites, Conduct of clinical site initiation visits.
  • Conduct of site monitoring visits to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with SOPs, state and central government regulations, guidelines and policies.
  • Ensure that clinical trials are conducted in compliance with Good Clinical Practice regulations, ICH guidelines, other state and federal applicable regulations, and internal Standard Operating Procedures.
  • Review of on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.

Clinical Research Associate

Apothecaries Clinical Research
New Delhi, India
03.2005 - 03.2006
  • Responsibility includes conduct of clinical site initiation visits; Conduct of site monitoring visits at NIMS, Global Hospital and Yashoda Hospital, Hyderabad, India to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with SOPs, state and central government regulations, ICH-GCP guidelines and policies.
  • Ensure that clinical trials are conducted in compliance with Good Clinical Practice regulations, ICH guidelines, other state and federal applicable regulations, and internal Standard Operating Procedures.
  • Review of on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.

Education

M. Sc. - Microbiology

M.V.R. P.G College
Visakhapatnam, Andhra Pradesh, India
05.2004

B. Sc. - B.Z.C

V. R. S. & Y. R. N. College
Chirala, Prakasam (Dist), India
06-1999

Skills

  • Good Clinical Practice (ICH-GCP)
  • FDA Regulations
  • Site Management
  • Vendor Management
  • Clinical Operations
  • Qualification, Initiation, Monitoring & Close Out Visits
  • Risk Management and Mitigation
  • Clinical Trial Management System (CTMS)
  • Clinical Trial Management and Execution
  • Electronic Trial Master File (eTMF)
  • Electronic Data Capture (EDC)
  • Regulatory Compliance
  • Patient Recruitment and Retention Strategies
  • Feasibility, Study Start-up Management

Personal Information

Date of Birth: 05/29/1975

Languages

  • English, Fluent
  • Telugu, Fluent
  • Hindi, Fluent
  • Urdu, Conversational

Therapeutic Areas Of Expertise

  • Pulmonology- T.B, Asthma, Bronchiectasis & COPD
  • Oncology – Febrile Neutropenia & Broncho alveolar Carcinoma
  • Diabetes – Type II DM
  • Cardiology – NV Atrial Fibrillation, Chronic Heart Failure (CHF), Unstable Angina (UA) & PHRI- Population study on CABG and Myocardial Infarction
  • Urology – Complicated Urinary Tract Infection
  • Neuro Oncology- Anaplastic Astrocytoma Grade III
  • Traveler's Diarrhea
  • Deep Venous Thrombosis (DVT)
  • CINV (Chemotherapy Induced Nausea & Vomiting)
  • Hepatitis-C
  • Psychiatry (Bipolar Disorder)
  • Hepatitis B Vaccine study
  • Breast Cancer
  • Ovarian Cancer
  • HIV Vaccine Phase 1/2a study
  • Major depressive disorder
  • Multiple Myeloma
  • Asthma-EPD Study
  • Psoriasis
  • SLE
  • Hidradenitis Suppurativa (HS)

Key Highlights

20, 15, 2, 3, Received multiple recognitions

Timeline

Associate Clinical Operations Leader

PREXEL International
02.2022 - Current

Senior Clinical Research Associate

PAREXEL INTERNATIONAL
11.2011 - 01.2016

Sr Clinical Research Associate

PAREXEL INTERNATIONAL
12.2009 - 02.2022

Clinical Research Associate II

PAREXEL INTERNATIONAL
12.2009 - 10.2011

Sr. Clinical Research Associate

Global Hospitals
07.2008 - 11.2009

Clinical Research Associate

Asian Clinical Trials Ltd
04.2006 - 06.2008

Clinical Research Associate

Apothecaries Clinical Research
03.2005 - 03.2006

M. Sc. - Microbiology

M.V.R. P.G College

B. Sc. - B.Z.C

V. R. S. & Y. R. N. College
Siva Kumar Pannem