Manager: Clinical Research & Operations

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Manager: Clinical Research & Operations Posted by Mid-Sized Firm in Pharma & Life Sciences Sector Mumbai (All Areas) Posted: imported by Jeevika JobsPopular categoriesIT jobsSales jobsMarketing jobsData Science jobsHR jobsEngineering jobsJobs in demandFresher jobsMNC jobsRemote jobsWork from home jobsWalk-in jobsPart-time jobsJobs by locationJobs in DelhiJobs in MumbaiJobs in BangaloreJobs in HyderabadJobs in ChennaiJobs in PuneCompaniesExplore categoriesUnicornMNCStartupProduct basedInternetExplore collectionsTop companiesIT companiesFintech companiesSponsored companiesFeatured companiesResearch companies by AmbitionboxInterview questionsCompany salariesCompany reviewsSalary CalculatorServicesAI career toolsNeo AI job agentResume score checkerAI resume makerInterview Q&AAI mock interviewLive AI interviewPremium servicesNaukri ProMost popularExpert resume writingExpert power profileAI BootcampsNewFree resourcesResume samplesJob letter samplesSearch jobs hereLoginRegisterFor employersBuy onlineNaukri Talent CloudEmployer LoginManager: Clinical Research & OperationsSwati Spentose3.775 Reviews3 - 6 years50,000-1 Lacs P.A. Mumbai (All Areas)( Churchgate, Mumbai Central, Dadar, Andheri, Ghatkopar )Posted: 5 days agoOpenings: 1Applicants: 41Manager: Clinical Research & OperationsSwati Spentose3.775 ReviewsJob description Company: Swati Spentose Pvt. Ltd.Department: Clinical ResearchDesignation: Manager Clinical Research & Clinical OperationsExperience: 3-6 yearsLocation: Mumbai Reporting To: Head Clinical Research Swati Spentose is looking for an experienced Manager Clinical Research & Clinical Operations to lead and manage the company's clinical research activities and provide end-to-end operational oversight of clinical trials.The candidate will be responsible for planning, initiating, executing and closing clinical trials, while ensuring compliance with applicable regulatory requirements, ICH-GCP, study protocols and company SOPs.The role will involve significant interaction with CROs, investigators, clinical sites, CRAs, vendors and internal cross-functional teams. The individual will also be responsible for clinical trial budgets, vendor negotiations, timelines, study quality and operational delivery.We are looking for a hands-on clinical research professional who has progressed through roles such as CRA, CRC, Clinical Trial Manager or Clinical Project Manager and is ready to take ownership of clinical research operations.Key Responsibilities1. Clinical Trial Planning & ExecutionLead clinical trials from study start-up through study close-out.Develop and manage study plans, timelines, milestones and operational deliverables.Coordinate site feasibility, site selection, activation and initiation activities.Oversee patient recruitment, retention and site performance.Monitor study progress and ensure timely achievement of clinical milestones.Identify operational challenges and implement appropriate corrective and preventive actions.Ensure smooth coordination between clinical sites, CROs and internal teams.2. CRO & Clinical Site ManagementIdentify, evaluate and oversee CROs and other clinical research vendors.Manage relationships with investigators, hospitals, clinical sites and study teams.Review CRO proposals, work scopes and study plans.Monitor CRO performance against agreed timelines, quality standards and deliverables.Review monitoring reports and follow up on site-level issues.Ensure timely resolution of site and study-related issues.3. Clinical Trial Budget & Contract NegotiationDevelop and manage clinical trial budgets.Review CRO and vendor commercial proposals.Negotiate CRO, investigator and site budgets.Review contracts, payment milestones, change orders and additional cost requests.Monitor study expenditure against approved budgets.Work closely with Finance, Procurement and Legal teams for contracts and payments.Identify opportunities for effective cost management without compromising study quality or compliance.4. GCP & Regulatory ComplianceEnsure clinical studies are conducted in accordance with:ICH-GCPApplicable regulatory requirementsApproved clinical trial protocolsEthics Committee/IRB requirementsCompany SOPs and quality standardsEnsure appropriate maintenance of essential clinical trial documentation and TMF.Support regulatory and Ethics Committee submissions where required.Support audit and inspection readiness.Ensure appropriate tracking and resolution of protocol deviations and quality issues.5. Clinical Team LeadershipCoordinate and lead cross-functional clinical trial teams.Work closely with Medical, Regulatory Affairs, Pharmacovigilance, Quality Assurance, Data Management and other relevant functions.Guide and supervise CRAs, clinical research associates/coordinators and external study teams as applicable.Conduct regular study review meetings.Track action items, risks, timelines and deliverables.6. Study Monitoring & ReportingReview overall study performance and key operational metrics.Track:Site activationPatient recruitmentPatient retentionMonitoring statusProtocol deviationsData/documentation statusStudy timelinesBudget utilizationPrepare periodic clinical trial status reports for senior management.Escalate critical operational, financial or quality risks in a timely manner.7. Vendor & Stakeholder ManagementMaintain effective working relationships with CROs, investigators, hospitals, laboratories and other external partners.Evaluate vendor performance and ensure compliance with agreed deliverables.Participate in vendor selection and qualification activities.Resolve operational and commercial issues through effective negotiation and stakeholder management.Candidates with a career background involving one or more of the following are preferred:Clinical Research Associate (CRA)Clinical Research Coordinator (CRC)Clinical Trial Manager (CTM)Clinical Project ManagerClinical Research ManagerClinical OperationsRole: Research & Development - Other,Industry Type: Clinical Research / Contract Research,Department: Research & Development,Employment Type: Full Time, PermanentRole Category: Research & Development - OtherEducationPG: M.Pharma in Any Specialization, MS/M.Sc(Science) in Any SpecializationKey SkillsSkills highlighted with ‘‘ are preferred keyskillsClinical OperationsClinical MonitoringResearch AnalysisClinical TrialsAbout companySWATI is a global research-oriented pharmaceutical company with a vision to take science to market. Headquartered in Mumbai, with a distinguished history spanning over five decades. Our commitment extends beyond expanding our product range, for the past twenty-five years, we have dedicated ourselves to addressing neglected diseases. SWATI is recognized for its unwavering commitment to quality, compliance, and innovation, serving a diverse clientele across more than 70 countries. With multiple advanced API and intermediate manufacturing facilities in Vapi, Gujarat, the company fully integrates its core product lines, encompassing the entire value chain from production to finished formulations. Our Purpose Our distinguished record in research, extensive global FDA accreditations, and strategic collaborations with leading international universities underscore its commitment to providing groundbreaking solutions to complex global health issues. SWATIS journey epitomizes its core identity and heritage as a pioneering, globally focused research-driven organization. With a vision to translate scientific advancements into market-ready solutions, the company has demonstrated remarkable resilience by navigating a 20-year path to deliver its innovative products to patients in need. SWATI has achieved groundbreaking success on a global scale in addressing rare and neglected diseases related to women’s bladder health. Interstitial cystitis (IC), also known as bladder pain syndrome (BPS), is a chronic condition characterized by bladder pain, pressure, and discomfort. It often leads to frequent and urgent need to urinate and can significantly impact a person’s quality of life. Diseases such as IC are often neglected by the global health community and are characterized by limited research and development funding, scarce access to affordable treatments, and inadequate healthcare resources. Our mission is unwavering in its dedication to tackling global health challenges by advancing novel treatments for diseases that currently have no effective solutions. Company InfoAddress:A-1/2102-2103, SWATI SPENTOSE PVT LTD, GIDC PHASE III, VAPI, Valsad, Gujarat, 396195 , VAPI, Gujarat, IndiaBeware of imposters! Naukri.com does not promise a job or an interview in exchange of money. 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