Job Description

Manager Clinical Operations Role

Manager Clinical Operations 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. Manager Clinical Operations 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.

Responsibilities (Associate Clinical Operations Manager/Clinical Operations Manager/Senior Clinical Operations Manager)

Line Management

• Act as line manager for one or more assigned CRAs, SCRAs, PCRAs; 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 or bi-weekly upon LM’s decision, 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 reviews take place in accordance with company procedures.
• Maintain promotion and succession plan for own teams.
• Review and approve leave requests for line reports in line with company policy.
• Ensure resource and recruitment are well aligned and timely managed in collaboration with relevant parties, participate in interviews for potential new hires.
• Actively seek feedback and monitor the quality of line reports work on an ongoing basis.
• 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.

Finance

• Review and approve internal expenses within company policy.
• Ensure staff utilisation levels are maintained.
• Review and approval of timesheets of direct reports.

Project Execution and Delivery

• Work alongside line reports to understand regional project objectives and facilitate local project delivery.
• In addition to above the Associate Manager may also need to perform Billable responsibilities of CRA or Clinical lead (refer to job description) on assigned projects.

Learning and Development

• Identify learning and development needs of staff.
• Contribute to the delivery and training of staff.
• 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.

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.
• 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 depot, couriers, local regulatory consultants, and translators).

Clinical Operations Manager and Senior Clinical Operations Manager

Business Development (if applicable)

• Represent Novotech at conferences and meetings.
• Understand local trial conditions and advise Operations and BD of any developments.
• Identify opportunities to expand Novotech business within existing projects.
• Represent Novotech at bid defence meetings.

Senior Clinical Operations Manager

• Contribute to training of staff and have responsibility for Clinical operations members across multiple country locations and 1-2 layers of line reports.
• To support and promote the Novotech Mission and Vision.

Minimum Qualifications & Experience

• Graduate in a clinical or life-sciences related field and/or line management experience within the pharmaceutical industry.

Experience:

Associate Clinical Operations Manager

• At least 5 years’ experience in clinical research, including considerable monitoring experience as a CRA/SCRA or similar.
• Previous mentoring or staff supervision experience desirable.

Clinical Operations Manager

• At least 7 years’ experience in clinical research, including considerable monitoring experience as a CRA/SCRA or similar.
• CRO experience, line and/or matrix management experience are highly regarded.

Senior Clinical Operations Manager

• At least 3 years line and/or matrix management experience within the CRO industry.

For all the above roles, relevant experience/qualifications in allied professions may also be considered.