Clinical Trial Manager

12.00 to 16.00 Years Surat,Other Gujarat 19 Jun, 2024

Job Location	Surat,Other Gujarat
Education	Not Mentioned
Salary	Not Disclosed
Industry	Medical / Healthcare
Functional Area	Not Mentioned
EmploymentType	Full-time

Job Description

We are looking for a clinical trial manager to implement and oversee projects, and to ensure the quality of trials. The clinical trial manager collaborates with the clinical project to review budgets, make changes where necessary, and outline projects together with the client and clinical monitoring team. The clinical trial manager regularly visits clinical trial investigators.Clinical Trial Head Responsibilities: The primary responsibility for a clinical trial manager is managing new and ongoing clinical trials Manage CRO, Data Management Institutes, Core labs and other related venders, ensure timely execution of study milestones. Clinical Investigations of medical devices - application assessment, post-approval assessments, SAE assessment, sponsor advice and education. Manage independent consultants and CRAs. Ensure study adherence to all regulatory matters and sponsor requirements according to global regulation (USFDA, EU MDR, MDSAP, GCP, ICH guidelines). Collaborate. with trial sites to ensure all trial activities are perform within guidelines and regulations (FDA, EU MDR, GCP). Perform regular reviews of data according to data review/monitoring guidelines. Review operational aspects of clinical protocols and provides clinical oversight for trial implementation activities. Lead the creation and execution of clinical documentation including dossier related to EC submission, TMF. Review and Assessment of clinical evaluation reports and related documentation, post-market surveillance and post-market clinical follow-up documentation as part of market surveillance of medical devices. Assessment of clinical aspects and benefit-risk assessments relating to vigilance Effective communication and engagement with relevant stakeholders including healthcare professionals. Management of all SIVs, including protocol and EDC training Review and update internal SOPs Assuring compliance according to internal SOPs and global regulationsClinical Trial Head Requirements: Postgraduate or Ph.D. degree 12 years of work experience for a medical device company or related field. Proficient understanding of marketing and statistics. Outstanding communication skills, both verbal and written. Proficient with Microsoft Office Word and Excel. Ability to work independently and prioritize duties. Understanding of Electronic Data Capture (EDC). Available to travel,

Keyskills :
Project ManagementBudget ManagementClinical MonitoringRegulatory ComplianceClinical DocumentationMedical DevicesData ManagementVendor ManagementRisk AssessmentCommunication SkillsStakeholder EngagementClinical Trial Management

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