Clinical Operations Manager

1 week ago


กรงเทพมหานคร, Thailand Novotech Asia Full time

**Brief Position Description**

Clinical Operations Manager - 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.

Clinical Operations Manager - this role will contribute to training of staff and Senior Clinical Operations Manager may have responsibility for Clinical operations members in multiple country location and 1-2 layers of line reports.

**Minimum Qualifications and Experience**
- 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.
- Solid background in onsite monitoring.
- Previous and extensive people management, performance management and staff development experience.
- Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments.

**Responsibilities**
- Act as line manager for one or more assigned CRAs; serve as a designated mentor to assigned clinical operations staff.
- Ensure induction process is completed as per company policy for all line reports on commencement of employment with the organisation.
- Ensure line reports are aware and understand company policies and procedures appropriate to their position.
- Meet regularly (in probation weekly, moving to a minimum of monthly) with 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 management is aware of line report performance progress, and informed of any issues arising.
- Ensure performance review take place in accordance with company procedures.
- Maintain promotion and succession plan for own teams.
- Review and approve internal expense requests and leave requests for line reports in line with company policy.
- Assist management team in resource management and recruitment, particulate in interviews for potential new hires.
- Conduct accompanied monitoring assessments and co-monitoring visits to ensure compliance with Novotech SOPs, ICH GCP Guidelines and local regulatory requirements as per Novotech guidelines.
- Actively seek feedback and monitor the quality of line reports work on an ongoing basis.
- Liaise with the Clin Ops management team, Learning and Development Manager and Project Managers as necessary, to address individual learning requirements for line reports.
- Contribute to the preparation, review, approval and delivery of clinical training to Clin Ops members
- Regular review and maintenance of clinical operations processes, tools and SOPs as requested.



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