Neha Singh

Results-driven Clinical Research Associate with 11 years of progressive experience in clinical trial monitoring, site management, and regulatory compliance across Ophthalmology, Gynaecology, Pulmonology, Vaccines, endocrinology and Medical Devices. Proven ability to manage complex, multi-site studies independently across CRO and sponsor-dedicated environments. Expert in remote and onsite monitoring (PSV, SIV, SMV, COV), SDV/SDR, risk-based monitoring (RBM), and TMF management.

Proficient in Veeva Vault, CTMS, Phlex, Florence, Octalsoft, and Siebel.

Clinical Research Associate - ICON Plc

(2022-07 - 2026-03)

• Independently conducted remote PSV, SIV, ongoing monitoring, and site close-out visits across multiple therapeutic areas in compliance with GCP/ICH guidelines and sponsor SOPs.
• Remotely identified, evaluated, and selected qualified investigators for multi-site clinical trials, including assessment of site infrastructure, staff competency, and patient recruitment potential.
• Partnered with investigators and coordinators to ensure protocol adherence, proper IMP storage/accountability, and accurate CRF data entry across geographically distributed sites.
• Executed comprehensive SDV/SDR activities ensuring consistency between source documents and electronic data systems; resolved data queries within defined timelines.
• Authored detailed monitoring visit reports, follow-up letters, and deviation logs with recommended corrective actions; tracked resolution and escalated persistent issues appropriately.
• Managed IMP reconciliation and accountability; ensured proper documentation and return/disposal of unused investigational supplies per protocol requirements.
• Maintained site-level eTMF filings in compliance with sponsor TMF reference models and regulatory standards.
• Successfully led site preparation and managed a DCGI (Drug Controller General of India) regulatory audit with zero findings — demonstrating full compliance with Indian regulatory requirements and ICH-GCP standards.

Clinical Research Associate - IQVIA

(2021-01 - 2022-06)

• Conducted PSV, SIV, routine monitoring, and site close-out visits in line with approved protocols, GCP, and ICH guidelines across assigned therapeutic indications.
• Verified investigator qualifications, facility adequacy, staff training completeness, and laboratory certifications during site qualification and initiation activities.
• Reviewed and verified adverse events (AEs), serious adverse events (SAEs), concomitant medications, and protocol deviations; ensured accurate and timely regulatory reporting.
• Completed monitoring visit reports and follow-up letters within sponsor-mandated timelines, clearly summarizing findings, deviations, and required corrective actions.
• Maintained regulatory document binders (ISF/CSF) and supported eTMF archiving per IQVIA and sponsor SOPs.
• Ensured IMP storage conditions, dispensation accuracy, and accountability at all times; coordinated with site pharmacies and investigator teams.
• Successfully supported 2 sponsor-initiated audits across assigned sites; facilitated audit preparation, document retrieval, and real-time query resolution — all concluded without critical findings.

Clinical Research Associate - Lambda Therapeutics Ltd

(2020-02 - 2020-12)

• Monitored clinical research activities across assigned sites, including study supply coordination, protocol compliance, and data quality oversight.
• Oversaw data collection, CRF completion, and electronic data transmission to data management centers; followed up on data queries and discrepancies promptly.
• Coordinated with ethics committees to ensure patient confidentiality and adherence to regulatory requirements throughout the study lifecycle.
• Prepared post-trial close-out reports; supported archiving and publication preparation activities.

Project Manager III - Clinwave Research Pvt Ltd

(2018-02 - 2020-02)

• Led end-to-end clinical trial operations including timeline management, budget tracking, resource planning, and vendor oversight across multi-site studies.
• Directed Trial Kick-off meetings, coordinated trial master file (TMF) setup, and finalized Clinical Trial Agreements (CTAs) and budgets with sites and vendors.
• Reviewed and approved monitoring visit reports; tracked and resolved site-level issues and protocol deviations within agreed timelines.
• Managed investigator payment processes in collaboration with the finance team; approved vendor invoices ensuring accurate and timely disbursements.
• Provided direct operational support to Clinical Site Managers and ensured study documentation was archived per SOPs and regulatory requirements.

Regional Clinical Research Associate - Genelife Clinical Research Pvt Ltd

(2015-06 - 2018-01)

• Oversaw site initiation, qualification, and monitoring activities; participated in protocol review, regulatory submissions, and ethics committee interactions.
• Conducted pre-study site visits, evaluated investigator qualifications and site capabilities, and contributed to final site selection decisions.
• Trained site personnel on protocol-specific requirements, sponsor SOPs, and applicable regulatory guidelines during SIV and routine monitoring visits.
• Reviewed CRFs, source documents, and site files for accuracy and compliance; identified deficiencies and initiated corrective actions.
• Assisted in study termination activities including test article reconciliation, file completeness review, and preparation of termination reports.

Clinical Research Coordinator - MV Hospital and Research Centre

(2014-01 - 2015-06)

• Managed research budgets, patient consent processes, and study documentation including CRFs, drug dispensation records, and regulatory forms.
• Monitored study activities for protocol compliance and coordinated with investigators, laboratories, and regulatory agencies.
• Participated in sponsor and regulatory audits; prepared sites for quality assurance inspections.

Bachelors - Biotechnology (2014)

XII - ISC (2009)

X - ICSE (2007)