Associate Manager Clinical Support
Novotech · Durham, NC · 1 wk ago
Hybrid$85k–$125k/yrFull-time
Provides supervision, leadership, and line management of the Clinical Support team. Ensures clinical trials are conducted according to ICH GCP guidelines, local regulatory requirements, Novotech/client SOPs, and the Project Agreement.
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.
- 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, 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.
- Associate Manager may also perform or support billable responsibilities of an Inhouse CRA 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.
Requirements
- 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.
Pay
$85,000 – $125,000. Salary offered will be based on candidate’s experience level.
Benefits
- Flexible working options.
- Paid parental leave for both parents.
- Flexible leave entitlements.
- Wellness programs.
- Ongoing development programs.