Bharani Vijayan

Results-driven Site Selection Specialist with 8+ years in clinical research, expert in global site selection strategies, and investigator due diligence. Proven ability to enhance clinical trial feasibility, optimize site start-up, and ensure GCP and regulatory compliance. Adept at data analysis and time-sensitive deliverable management, consistently contributing to successful research initiatives

Site Selection Specialist - Fortrea (Formerly Labcorp Drug Development) - Mumbai

(2022-01 - 2026-02)

• Contributed to global site selection strategies as part of a PI Contact Task Force within a Functional Service Provider (FSP) model, supporting multi-regional clinical trials.
• Led investigator identification and PI contact tracing initiatives, enabling efficient investigator engagement and improved site feasibility outcomes.
• Performed advanced site intelligence analysis, including investigator profiling, site validation, and feasibility assessment aligned with study protocols.
• Managed data quality initiatives, including deduplication of site databases, SDL reconciliation, and investigator affiliation verification.
• Delivered high-quality curated datasets to support data-driven site selection decisions for clinical operations and feasibility teams.
• Collaborated cross-functionally with Feasibility, Site Start-Up (SSU), Clinical Operations, and vendor partners to accelerate study start-up timelines.
• Ensured operational excellence through strict adherence to project timelines, quality standards, and regulatory expectations.

Clinical Study Start-up – Due Diligence Specialist - ICON plc - Chennai

(2018-09 - 2022-01)

• Conducted comprehensive investigator and institutional due diligence searches to support clinical trial feasibility and Site Start-Up activities.
• Reviewed regulatory, compliance, and reputational risks to determine site suitability in line with FDA and sponsor expectations.
• Partnered closely with Legal and Compliance teams to assess and track issues noted against investigators or institutions.
• Documented due diligence outcomes and resolutions within the ISPRINT database, ensuring traceability and audit readiness.
• Executed World-Check screenings to identify adverse media, sanctions, or compliance risks related to investigators and institutions.
• Provided structured inputs and risk assessments to Feasibility teams for informed site selection decisions.
• Supported monthly management reporting, metrics tracking, and operational dashboards.
• Led internal quality reviews, identified process gaps, and recommended corrective and preventive actions.
• Ensured compliance with regulatory, ethical, and internal quality standards throughout all assignments

Associate research Analyst - Clarivate Analytics (Formerly IP&S division of Thomson Reuters) - Chennai

(2016-09 - 2018-05)

• Worked on the database GENESEQ™, involved in the novelty assessment, data mining of patents containing biological sequence information obtained from databases such as WIPO, USPTO, SIPO, IPRTOP, ESPACENET, and EPO.
• Identifying fields for anatids and delivering value-added scientific information as per client requirements that aid in genomic-based life science discovery.

M.Sc. - Biotechnology - VIT University (2013-01 - 2015-01)

B.Sc. - Biotechnology - University of Madras (2010-01 - 2013-01)