Clinical Quality Assurance Compliance
4 weeks ago
Job Title: Clinical Quality Assurance Compliance & trainingExperience: 5 plus yearsLocation: MumbaiType: Full-timeExperience Level: [Senior] Manager/Senior ManagerDepartment: Clinical Research DepartmentPurpose of this Role:This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspection/audit readiness. This role will be responsible for establishing the procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures.Develop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices. Identify and decide team member’s job specific SOP training requirements in view of their role and maintain oversight of training to ensure all team members are trained on each SOP as required. Preparation of SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team. Quality review of the clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement. Quality review of the clinical trial operation related activities, related tools, plans and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring – site specific reports, Site Documents, logs and close out activities in line with ICH GCP requirement, Indian and global regulatory requirement.Required & Preferred Skills: • .5 years’ experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department. Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills. Must have experience in handling audits & inspections of DCGI, US FDA. Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials. Experience of working in matrix business environments preferred. Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards.
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Senior Clinical Research Associate
3 weeks ago
New Delhi, India MS CLINICAL RESEARCH Full timeJob Title:Senior Clinical Research Associate (Sr. CRA) Company:MS Clinical Research Pvt Ltd Experience:Minimum 5 yearsAbout Us MS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...
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Senior Clinical Research Associate
3 weeks ago
New Delhi, India MS CLINICAL RESEARCH Full timeJob Title: Senior Clinical Research Associate (Sr. CRA)Company: MS Clinical Research Pvt LtdExperience: Minimum 5 yearsAbout UsMS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...
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Clinical Research Coordinator
3 weeks ago
New Delhi, India MS CLINICAL RESEARCH Full timeAbout the JobWe are looking for passionate Clinical Research Coordinators (CRC) to join our growing team. This is an exciting opportunity for fresh graduates with a clinical research course or background in life sciences/pharmacy who want to build a career in clinical trials and research.Position DetailsRole: Clinical Research CoordinatorLocation:...
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Quality Assurance Auditor
3 weeks ago
New Delhi, India K3-Innovations, Inc. Full timeJob Title: Clinical Quality Compliance Manager Location: Bengaluru, Karnataka, IndiaReports To:QA/Compliance Director or Clinical Operations DirectorJob Summary:Clinical Site Auditor to ensure compliance and quality at Clinical Trial sites. You will conduct site audits, review documentation, and verify adherence to protocols, GCP, GLP and regulatory...
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Quality Assurance Auditor
3 weeks ago
New Delhi, India K3-Innovations, Inc. Full timeJob Title: Clinical Quality Compliance ManagerLocation: Bengaluru, Karnataka, IndiaReports To: QA/Compliance Director or Clinical Operations DirectorJob Summary:Clinical Site Auditor to ensure compliance and quality at Clinical Trial sites. You will conduct site audits, review documentation, and verify adherence to protocols, GCP, GLP and regulatory...
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Clinical Research Associate
4 days ago
New Delhi, India Zillan Clinical Research Full timeClinical Research Associate assistant / Senior Clinical Research Coordinator Seeking highly motivated Clinical Research Associate/ Senior Clinical Research Coordinator to work remotely This role will be a part time or full-time position during standard business hours in USA Job Overview Responsibilities for Clinical Research Associate/ Senior Clinical...
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Clinical Research Coordinator
3 weeks ago
Delhi, India MS CLINICAL RESEARCH Full timeAbout the JobWe are looking for passionate Clinical Research Coordinators (CRC) to join our growing team. This is an exciting opportunity for fresh graduates with a clinical research course or background in life sciences/pharmacy who want to build a career in clinical trials and research.Position DetailsRole: Clinical Research CoordinatorLocation:...
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Clinical Research Coordinator
3 weeks ago
Delhi, India MS CLINICAL RESEARCH Full timeAbout the Job We are looking for passionate Clinical Research Coordinators (CRC) to join our growing team. This is an exciting opportunity for fresh graduates with a clinical research course or background in life sciences/pharmacy who want to build a career in clinical trials and research. Position Details Role: Clinical Research Coordinator Location: Delhi...
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Clinical Head
2 weeks ago
New Delhi, India Talent Sutra Full timeJob Title: Clinical HeadJob Summary:As the Clinical Head of a hair replacement company, you will be responsible for overseeing and managing the clinical operations of the organization. Your primary focus will be on providing expert guidance, ensuring the highest standards of quality in clinical services, and driving continuous improvement initiatives. You...
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Clinical Research Coordinator
4 weeks ago
Delhi, India MS CLINICAL RESEARCH Full timeAbout the Job We are looking for passionate Clinical Research Coordinators (CRC) to join our growing team. This is an exciting opportunity for fresh graduates with a clinical research course or background in life sciences/pharmacy who want to build a career in clinical trials and research. Position Details Role: Clinical Research Coordinator Location: Delhi...
