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Job description: Clinical Research Associate/ Project Manager– Bioequivalence (BE) StudiesJob SummaryThe Clinical Project Manager (CPM) is responsible for the end-to-end management of sponsor-led bioequivalence (BE) studies conducted at Contract Research Organizations (CROs). The CPM ensures studies are delivered on time, within budget, and in compliance with regulatory requirements including U.S. Food and Drug Administration, European Medicines Agency, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines.The role serves as the primary liaison between the sponsor and CRO, overseeing study planning, execution, data review, reporting, and submission readiness.Key Responsibilities1. Study Planning & Start-upLead cross-functional study planning activities (Clinical, Regulatory, QA, Bioanalytical, PK, Data Management).Develop and review study protocols for bioequivalence trials (fasted/fed, replicate, parallel designs).Select and manage CROs and bioanalytical laboratories.Review and approve study-related documents:Protocol and amendmentsInformed Consent Forms (ICF)Investigator’s Brochure (if applicable)Case Report Forms (CRFs)Ensure regulatory strategy aligns with ANDA/MAA submission requirements.2. CRO & Vendor ManagementServe as primary sponsor contact for CRO.Conduct kickoff meetings and routine oversight meetings.Review and approve:Study timelinesMonitoring plansBioanalytical method validation reportsClinical study reports (CSR)Track KPIs and ensure adherence to contractual obligations.Manage issue escalation and risk mitigation strategies.3. Study Conduct OversightMonitors BA/BE studies to ensure compliance with protocols, regulations, and data quality standards.Ensure compliance with:ICH-GCPApplicable regulatory authority requirementsOversee:Subject recruitment and dosing progressSafety reportingProtocol deviationsData quality and query resolutionReview interim data and PK data outputs.4. Bioanalytical OversightReview bioanalytical method validation and sample analysis reports.5. Budget & Timeline ManagementDevelop and manage study budgets.Review CRO invoices and change orders.Monitor study milestones and ensure on-time database lock and CSR finalization.6. Regulatory & Submission SupportEnsure TMF completeness and audit readiness.Support preparation of:Module 5 documents for ANDA/NDA submissionsAddress regulatory queries related to clinical or BE data.7. Risk Management & Quality OversightIdentify operational risks early and implement mitigation plans.Participate in vendor audits and quality reviews.Ensure CAPA implementation when required.QualificationsEducationBachelor’s or Master’s degree in:PharmacyLife SciencesClinical ResearchPharmacologyExperience5+ years of experience managing bioequivalence studies.Sponsor-side experience strongly preferred.Technical KnowledgeStrong understanding of:Bioequivalence study designsPK principlesGCP and regulatory guidelinesClinical study report structure (ICH E3)Familiarity with electronic TMF systems and clinical databases.Core CompetenciesStrong project management skillsVendor oversight and negotiationRisk-based monitoring oversightBudget managementCross-functional leadershipExcellent communication and stakeholder management