Clinical Research Manager

About Panacea Biotec : We are one of the India’s leading Pharmaceutical & Biotechnology Company with demonstrated Research, Manufacturing and Brand Building capabilities. We have ultra-modern, state of the art manufacturing facilities for Vaccines that are cGMP compliant and WHO PQ. We have supplied more than 10+ billion doses of Polio vaccines and more than 190 million doses of fully-liquid innovative, first in the world vaccines for the Global immunization program.

Panacea Biotec has launched the world’s first fully-liquid wP-IPV Hexavalent vaccine, EasySix , the first Quadrivalent EasyFour –TT, the first Pentavalent, EasyFive-TT and the first wP-IPV based Quadrivalent, EasyFour-Pol. Strong vaccine pipeline across various diseases to be launched in the next 2-3 years. Position Summary The Manager of Clinical Research will play a pivotal role in the strategic operational planning, project management, and execution of domestic and international clinical trials for our vaccine portfolios.

This role drives clinical operations, vendor management, and regulatory compliance, ensuring that both in-house and outsourced trials meet the highest global standards (ICH-GCP, DCGI, WHO, USFDA, EMA) and are delivered on time, within budget, and with high data quality. Key Roles, Responsibilities, and KRAs 1. Clinical Trial Operations & Project Management Manage the end-to-end operational execution of in-house and outsourced clinical trial studies.

Review and approve essential clinical trial operational documents (e.g., Clinical Monitoring Plans, Project Management Plans, Site Feasibility Reports, and Patient Recruitment Strategies). Provide operational leadership to the study team during site evaluation, selection, regulatory and Ethics Committee (EC) submissions, study initiation, conduct, and closeout. Ensure comprehensive operational protocol training is provided to Clinical Research Associates (CRAs) and study site personnel.

Manage trial budgets, timelines, and resources, and coordinate with cross-functional teams (including the Medical Monitor) to ensure timely data cleaning, database lock, and the finalization of Clinical Study Reports (CSRs). 2. CRO & Vendor Management (Outsourced Trials) Lead or assist Senior Management in the evaluation, selection, and contracting of Clinical Research Organizations (CROs) and other third-party vendors (e.g., central laboratories, clinical supply depots). Coordinate extensively with partner CROs to finalize clinical trial timelines, budgets, and operational plans.

Provide ongoing operational oversight to partner CROs across all trial phases, tracking Key Performance Indicators (KPIs) and ensuring strict adherence to the agreed Scope of Work (SOW). 3. Clinical Documentation & Regulatory Support Ensure the Trial Master File (TMF) is established, maintained, and audit-ready throughout the study lifecycle. Collaborate with the Medical Monitor, Medical Writers, and Regulatory Affairs teams to facilitate the timely submission of clinical documents (e.g., Protocols, Investigator Brochures, CSRs) to regulatory bodies.

Support clinical operations data gathering for regulatory submissions and ensure clinical trial registries (e.g., CTRI, ClinicalTrials.gov) are accurately updated and maintained. 4. Quality Assurance & Regulatory Compliance Prepare, review, and update Standard Operating Procedures (SOPs) governing clinical research operations and site monitoring. Formulate and implement robust Corrective and Preventive Action (CAPA) plans in response to Quality Assurance (QA) audits, site monitoring visits, and protocol deviations.

Ensure all clinical operations activities strictly adhere to ICH-GCP guidelines and applicable local and international regulatory frameworks. 5. Cross-Functional Collaboration & Strategy Actively participate in clinical development project teams. Contribute strategic operational insights (timeline, budget, and resource feasibility) during project review meetings for Panacea Biotec products, ensuring alignment with overall R&D and business objectives.

Qualifications & Experience Education: Master’s degree in Pharmacy (M.Pharm), Life Sciences, Biotechnology, or a related field. A Post-Graduate Diploma in Clinical Research or Clinical Trial Management is highly preferred. Experience: Minimum of 8 to 12 years of core experience in clinical operations, clinical project management, and site monitoring Proven experience in managing and monitoring Vaccine Clinical Trials across domestic and international geographies.

Prior experience in CRO evaluation, budget negotiation, selection, and vendor management. Technical & Functional Skills: Strong command of clinical trial project management, financial budgeting, and Trial Master File (TMF) management. In-depth knowledge of global clinical research guidelines (ICH-GCP) and regulatory frameworks (DCGI, WHO, FDA, EMA).

Expertise in CAPA implementation, monitoring oversight, and QA audit handling. Soft Skills: Strong analytical capabilities, excellent project management skills, leadership, problem-solving, and cross-functional stakeholder management. Interested candidates may share their resume at sandeepsingh@panaceabiotec.com