Job Description

Role Summary

The Associate Manager/Manager/Senior Manager role - Clinical Support provides Supervision, leadership, and line management of the Clinical Support team. The Clinical Support management role will ensure that line reports are trained and managed to conduct clinical trials according to ICH GCP guidelines, local regulatory requirements, Novotech/client SOPs, and the Project Agreement.

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

Responsibilities:

Line Management
• Act as line manager for one or more assigned Inhouse 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 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.
• Assist management team in resource management and recruitment, 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 Services management team, Learning and Development and CRAs as necessary, to address individual learning requirements for line reports.
• Participate in activities of the Clinical Services 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 or support Billable responsibilities of an Inhouse CRA (refer to job description) on assigned projects.

General Responsibilities:
• 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 clinical or life sciences, business administration, management, or related field.
• At least 3 - 5 years' experience in clinical research, including experience as an Inhouse CRA/CTA/CRA or similar. Previous mentoring or staff supervision

experience desirable.

Salary Band - $85,000 - 125,000 Salary offered will be based on candidates experience level.