Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.
Post : Manager Clinical Operations (Senior)
Job Description
Clinical Operations Manager/Senior Clinical Operations Manager Role – this role provides supervision, leadership, and line management of the Clinical operation team. This role will ensure that line reports are trained and managed to conduct clinical trials according to ICH-GCP guidelines, local regulatory requirements, Novotech / client standard operating procedures (SOPs), and the Project Agreement.
Responsibilities
• Act as Novotech ambassador for Novotech India team and attend BDM and client meetings to lead India Clinical services capabilities discussions.
• Work with Business Development to drive new business for Novotech India Clinical Services
• Act as line manager for assigned CRAs, IHCRAs, RSAs; serve as a designated mentor to assigned clinical operations staff.
• Meet regularly line reports to review their workload, welfare, and developmental needs.
• Set and agree written goals and objectives, perform annual appraisal interviews and end of probation appraisals; submit promotion requests to management as appropriate.
• Ensure resource and recruitment are well aligned and timely managed in collaboration with relevant parties, participate in interviews for potential new hires.
• Liaise with the Clinical Operations management team, Learning and Development and CRAs as necessary, to address individual learning requirements for line reports.
• Participate in activities of the Clinical Operations department, including presentation at clinical team meetings and, attendance at company meetings and contributing to the development of clinical processes and SOPs.
• Ensure staff utilisation levels are maintained. Review and approval of timesheets of direct reports
• Work alongside line reports to understand regional project objectives and facilitate local project delivery.
• Conduct accompanied monitoring assessments and co-monitoring visits to ensure compliance with SOPs, ICH-GCP guidelines and local regulatory requirements as per NVT/ Client guidelines.
• Establish and lead relationships with key clinical trial sites and opinion leaders.
Candidate Profile
• Graduate in a clinical or life-sciences related field and/or line management experience within the pharmaceutical industry.
• At least 7 years’ experience in clinical research, including considerable monitoring experience as an CRA/SCRA or similar. CRO experience, line and/or matrix management experience are highly regarded.
• At least 3 years line and/or matrix management experience within the CRO industry.
Additional Information
Experience : 3-7 years
Qualification : Graduate in a clinical or life-sciences
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Operations
End Date : 30th May 2025
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