Hire Talented Clinical Operations Coordinators (CTMA / CTC)

Manager – Medical Writing, Pharmacokinetics & Clinical Trials

Clinical Research and Medical Writing professional with 12+ years of experience in pharmacokinetics, bioavailability/bioequivalence (BA/BE) studies, and global clinical trial operations across Phase I–IV and post-marketing surveillance. Expertise in protocol development, CSR writing, regulatory submissions (CTD modules), and handling PK/PD data analysis using Phoenix WinNonlin. Proven track record of managing multicenter clinical studies, leading cross-functional teams, and ensuring compliance with international regulatory guidelines (USFDA, MHRA, ANVISA, WHO, TGA, CDSCO). Experienced in partnering with CROs, overseeing audits and inspections, and delivering high-quality clinical and regulatory documentation to support product development and approvals.

Clinical Operations Manager

Clinical Operations Manager with 9 years of experience leading end-to-end clinical trial execution across interventional and non-interventional studies in Diabetes, Cardiology, and Hemophilia. Proven track record in establishing clinical research functions from the ground up, managing cross-functional teams, and ensuring regulatory compliance with ICH-GCP and global standards. Skilled in project planning, site/vendor management, budgeting, and operational oversight. Adept in using CTMS, EDC, and eTMF systems to drive study efficiency, improve data quality, and maintain inspection readiness. Recognized for strong leadership, stakeholder collaboration, and delivering high-impact clinical programs aligned with organizational and regulatory requirements.

Manager – Clinical Operations Delivery

Clinical Operations Manager with 11+ years of experience overseeing global clinical trial delivery, TMF operations, and cross-functional team leadership within pharmaceutical and CRO environments. Proven track record in improving study efficiency, enhancing TMF quality, and enabling audit readiness through process automation and data-driven decision-making. Demonstrated success in managing large operational teams, optimizing performance KPIs, and aligning study execution with ICH-GCP, regulatory, and sponsor expectations. Advanced expertise in Veeva Vault, CTMS, and process automation tools, with strong focus on operational excellence, stakeholder management, and continuous improvement. PMP certified.

Clinical Operations Manager

Clinical Research Professional with 8+ years of progressive experience in clinical operations, site management, and end-to-end trial execution across multiple therapeutic areas including immunology, endocrinology, virology, oncology, and gastroenterology. Proven expertise in managing Phase II–IV studies, overseeing site readiness, monitoring activities, ensuring protocol adherence, and maintaining regulatory compliance (ICH-GCP, NDCT). Adept at budgeting, CTA negotiation, SOP development, audit preparedness, and team leadership. Skilled in leveraging clinical systems such as Medidata Rave, Veeva Vault, Octalsoft, Clinion, REDCap, and CTMS/eTMF platforms to ensure data integrity, documentation accuracy, and operational efficiency across India, Nepal, and Africa.

Manager – Clinical Operations

Clinical Operations Manager with 12+ years of experience overseeing global clinical trials across the US, EU, and APAC regions. Proven expertise in centralized and remote monitoring, global project management, and cross-functional team leadership. Strong track record in Phase I–IV clinical studies, BA/BE trials, and medical device research, ensuring adherence to ICH-GCP and regulatory requirements. Known for driving process improvements, optimizing resource allocation, managing database lock activities, and ensuring audit/inspection readiness (USFDA, ANVISA). Adept in mentoring high-performing teams and utilizing EDC/CTMS/eTMF platforms to ensure operational excellence and data quality.