Job Description
The Clinical Operations Manager (COM) provides line management of a team of Clinical Research Associates (CRAs), Senior CRAs (SCRAs), Clinical Trial Assistants (CTAs), and/or administrative staff and ensures that line reports conduct clinical trials according to all applicable Good Clinical Practice (GCP) guidelines, regulatory requirements, Standard Operating Procedures (SOPs) and the Project Agreement. The COM will support the project teams on operational oversight for clinical activities, as well as responsible for resourcing and staffing, assess performance, mentor, and resolve clinical operational issues.
Responsibilities
- Act as line manager for one or more SCRAs, CRAs, CTAs, PMs, and/or administrative staff
- In collaboration with Human Resources (HR) and senior management, identify resource needs and hire new staff
- Ensure all line reports receive appropriate induction on commencement of employment, and that they understand the company policies and procedures appropriate to their position
- Meet regularly with line reports, and review and manage their work quality, workload, welfare and developmental needs
- Performance management of line reports: set and agree goals and objectives; competency assessments; co-ordinate salary reviews and promotions, and maintain succession plans
- Review and assist with the development and maintenance of clinical operations processes, tools and SOPs
- Review and approve internal expense requests in line with company policy
- Review and approve leave requests in line with company policy.
Learning and Development
- Conduct accompanied monitoring assessments and co-monitoring visits to ensure compliance with SOPs, GCP Guidelines and regulatory requirements as per Novotech guidelines.
- Contribute to the development and delivery of training to Clinical Operations staff.
Business Development
- Represent Novotech at industry conferences and other professional meetings as delegated
- Assist with the conduct of feasibility assessments and provide feasibility information to BD
- Achieve and maintain a good understanding of the local and international clinical trial industry and provide advice to BD
- Identify and highlight opportunities within own projects or with existing clients to expand business collaborations
- Represent Novotech at bid defence meetings and other business development meetings with local and international clients.
Office and/or Country Management (if applicable)
- Establish and maintain relationships with key clinical trial sites and opinion leaders
- Establish and maintain relationships with local 3rd party vendors (e.g. central laboratories, drug distribution depots, couriers, regulatory consultants, and translators).
General:
- Adhere to Company policies, procedures and guidelines and be quality minded in performance of duties
- Identify areas of inefficiency and make recommendations for improvements
- Assist in the review and development of Novotech SOPs and guidelines
- Participate in activities of the clinical operations group, including coordination of and presentation at clinical team meetings
- Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry
- Ensure all communications with external parties and the performance of the study
- team presents a positive professional image of the company.
Minimum Qualifications & Experience:
- Graduate in a life sciences related field and/or line management experience within the pharmaceutical industry.
- Experience in a SCRA, PM, or similar role, including considerable monitoring experience.
- CRO experience, line and/or matrix management experience are highly regarded.
