Associate Manager Clinical Support

Life Sciences WA; Charleston (SC); On-site; USD 85,000 - 125,000; Full time

Job summary

Novotech is seeking an Associate Manager/Manager/Senior Manager - Clinical Support to supervise the Clinical Support team and ensure training and adherence to ICH GCP guidelines, local regulations, and SOPs. The role may involve multiple country locations and several line reports.

Responsibilities include mentoring staff, induction, performance reviews, and collaboration with Clinical Services and Learning & Development to address learning needs.

Qualifications

• 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; mentoring or staff supervision.

Responsibilities

• Act as line manager for one or more assigned Inhouse CRAs; mentor assigned clinical operations staff.
• Ensure induction for new line reports; ensure policy compliance and understanding of procedures.
• Conduct regular meetings to review workload, welfare, and development; set goals and conduct performance/appraisals.
• Assist management with resource planning, recruitment, and interviewing for new hires.
• Maintain promotion and succession plans; oversee leave approvals.

Skills

Line management

Mentoring staff

Training

Communication

Project coordination

Education

Graduate in clinical or life sciences

Job description

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

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

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.