(Senior) Manager Clinical Operations

7 - 11 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a Clinical Operations Manager/Senior Clinical Operations Manager at Novotech, you will play a crucial role in supervising, leading, and managing the Clinical operation team to ensure the successful conduct of clinical trials in adherence to ICH-GCP guidelines, local regulatory requirements, Novotech/client SOPs, and the Project Agreement. Key Responsibilities: - Act as the Novotech ambassador for the India team, leading discussions on India Clinical services capabilities in BDM and client meetings. - Drive new business for Novotech India Clinical Services in collaboration with Business Development. - Serve as a line manager for assigned CRAs, IHCRAs, RSAs, and mentor clinical operations staff. - Conduct regular meetings with line reports to review workload, welfare, and developmental needs. - Set written goals, perform annual appraisal interviews, and submit promotion requests as necessary. - Ensure alignment of resources and recruitment, participate in interviews for potential new hires. - Collaborate with Clinical Operations management team, Learning and Development, and CRAs to address individual learning requirements. - Participate in departmental activities, present at clinical team meetings, attend company meetings, and contribute to the development of clinical processes and SOPs. - Maintain staff utilisation levels, review and approve timesheets of direct reports. - Facilitate local project delivery by understanding regional project objectives and working alongside line reports. - Conduct monitoring assessments and visits to ensure compliance with SOPs, ICH-GCP guidelines, and local regulatory requirements. - Establish and nurture relationships with key clinical trial sites and opinion leaders. Qualifications Required: - Graduate in a clinical or life-sciences related field or have line management experience in the pharmaceutical industry. - Minimum 7 years of experience in clinical research with significant monitoring experience as a CRA/SCRA or similar role. - At least 3 years of line and/or matrix management experience within the CRO industry.,

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Novotech

Contract Research Organization (CRO)

Level 5

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