veeramanikandan's CV
veeramanikandan panchanathan
Clinical Research Professional, M.Sc., QMS Lead Auditor, ASM®, CSSGB, PMP®
Profile summary
Strategic clinical research professional with 17 years of experience shaping global trial outcomes across the GCC, APAC, Europe, and North America. Known for expertise in clinical trial management, risk-based quality management, and regulatory compliance. Fluent in English with basic Arabic and beginner Japanese, bringing cross-cultural team leadership across multiple international markets. Committed to steering operational excellence and ensuring adherence to good clinical practice standards.
Career highlights
Global Clinical Trial Management: Directs cross functional operations, vendor relationships, and risk based quality management methodologies across the APAC, Europe, and USA regions.
Quality Assurance Leadership: Performs routine audits in research sites across four regions, preparing good clinical practice reports and training personnel on quality management methods.
Regulatory Compliance Oversight: Tracks protocol deviations and ensures regulatory submissions to ethics committees and authorities remain current while maintaining trial master file oversight.
Quality Management Audit Certification: Holds an IRCA certified ISO 9001 2015 lead auditor credential from the British Standards Institute Training Academy.
Key skills
Professional experience
Defines global clinical trial management strategy, steering cross-functional operations and vendor relationships across APAC, Europe, and the USA. Directs study timelines, risk-based quality management methodologies, and budget forecasting while serving as the primary liaison for sponsors and internal departments.
- Oversees clinical trial management systems, tracking protocol deviations and ensuring regulatory submissions to ethics committees and authorities remain current.
- Coordinates monthly billing, budget forecasting, and invoice approvals for clinical sites and third-party organizations.
- Manages vendor relationships with imaging, central lab, electronic data capture, and third-party providers.
- Maintains trial master file oversight and directs audit preparation and response coordination across departments.
Directs monitoring operations across multiple international regions, reporting to the Senior Manager of Monitoring Resources, while overseeing clinical research associate supervision, performance tracking, compliance verification, and cross-functional communication with study leads and project managers.
- Steers monitoring activities for a breast cancer study as monitoring resources study lead.
- Conducts clinical research associate assessment visits, coordinates site handovers, and manages corrective action and preventive action replies.
- Delivers monitoring presentations on trial-specific country calls and assists with internal and external clinical research associate onboarding.
Steered clinical trial operations across European Union and Asia-Pacific regions, reporting to senior project management and directing multidisciplinary teams of clinical research associates and clinical trial assistants to execute multi-country projects.
- Partnered with central monitoring team on risk-based monitoring strategies, applying Cluepoints for key risk indicator tracking, signal detection, and quality tolerance limit management.
- Oversaw site selection, startup, budget reviews, institutional consent document preparation, and investigator or site payment processes while managing vendor relationships.
- Coordinated safety information flows, maintained electronic trial master files, prepared investigator newsletters, and ensured adherence to national regulations and good clinical practice standards.
Reporting to the Project Manager, shaped clinical operations across the APAC region including Australia, India, Taiwan, and South Korea, directing study startup, monitoring, and site management.
- Steered site audits and quality control visits to verify trial subject protection, data quality, and protocol compliance.
- Architected corrective and preventive action plans aligned with regulatory and sponsor standards.
- Executed feasibility assessments, site selection, initiation, routine monitoring, and closeout procedures for clinical investigation activities.
- Managed project setup, timelines, deliverable quality, and risk-based monitoring plan preparation alongside project managers.
- Introduced risk-based monitoring concepts for pilot research studies and updated standard operating procedures for clinical trials.
- Performed routine audits in research sites across four regions, preparing GCP reports with CAPA and training personnel on quality management methods.
- Managed electronic and paper case report forms alongside data query resolution processes.
- Maintained investigational products and coordinated local and central laboratory sample shipments.
- Conducted site initiation, routine monitoring, and close-out visits while verifying that trial data and source documents remained accurate and verifiable.
- Prepared monitoring initiation and follow-up letters alongside tracking adverse events, concomitant medications, and intercurrent illnesses against protocol standards.
Education
Biotechnology
Biochemistry
Certifications
Languages
English · Fluent
Arabic · Basic
Japanese · Basic