▷ (Immediate Start) Senior Clinical Research Manager

We are seeking an experienced Senior Clinical Research Manager to join our Clinical and Project Operations team in NSW.

Location

New South Wales

Employer

Avance Clinical Pty Ltd

Employment Type

Full-time, ongoing

Job Summary

The Senior Clinical Research Manager (Snr CRM) is responsible for planning and executing clinical trials by coordinating study team members and processes to deliver projects on time, within budget and with the desired outcomes, ensuring the trial is conducted in accordance with the protocol, Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.

Core Responsibilities

- Leads internal teams and external stakeholders including sponsors, vendors and site staff across all stages of the assigned clinical research projects/studies.

- Develop study plans, operational documents, and department SOPs to support the effective execution of all project operations.

- Oversees financial performance of assigned clinical research projects, including budget development, revenue recognition, forecasting and contract management, invoicing, and payment tracking.

- Maintains effective communication with sponsors, senior management and external regulatory bodies (as needed) to manage project timelines, expectations, risks, and issues.

- Participates in and responds to study‑specific or vendor audits conducted by sponsors or regulatory agencies.

- Reviews study protocols and documentation, including Ethics Committee submission documents, evaluates and controls risks, and ensures accuracy and completeness of research data and Trial Master File (TMF) documentation.

- Provides guidance and mentoring to less experienced clinical research management staff members, supporting development of departmental knowledge and capability.

- Monitors and evaluates project performance from initiation to completion to ensure delivery of research outcomes and quality objectives.

- Reports progress and findings to senior management and sponsors, ensuring transparency on project outcomes and compliance status.

- Contributes to the development and implementation of departmental procedures, quality systems, and continuous improvement initiatives.

- Manages and mitigates operational and compliance risks related to assigned clinical research projects.

- Ensures protocol deviations are identified, documented, and reviewed in line with study plans.

- Ensures Serious Adverse Events are reported (initial and follow‑up) as per protocol requirements.

- Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications.

Departmental Responsibilities

- Foster the on‑going commitment to maintaining a healthy team culture and promoting good morale, by actively participating in regular Project Management Team meetings.

- Maintain effective communication with other members of the department.

- Proactively identify risks related to departmental service provision and assist in their mitigation and resolution.

- Manage and track business related expenses as per company policy.

- Identify training needs and provide suggestions for and support delivery of appropriate training actions and programs.

- Assist with the development of departmental SOPs as required.

- Participate in internal Quality Assurance activities as required, including responding to audit findings.

Organisational Responsibilities

- Embrace the core values of Avance Clinical and endeavour to display those attributes at all times with clients and staff alike.

- Commit to Avance Clinical training programs.

- Adhere to Avance quality systems.

Qualifications, Skills, and Experience

- Bachelor’s level degree in life sciences, pharmacy, nursing, or equivalent field.

- Previous experience as a CRM or PM in a CRO or Pharma company for at least 3–5 years.

- Where applicable, previous related line management experience is desirable.

- Previous experience as a Clinical Research Associate (CRA) is highly regarded.

- Demonstrates leadership in applied research management within the pharmaceutical and/or biotechnology sector.

- Previous training and a working knowledge of ICH GCP and applicable regulatory requirements.

- Clear understanding of the requirement to adhere strictly to client confidentiality.

- Effective written and oral communication skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.

- Demonstrated ability to take initiative in problem solving and in exercising good judgment.

- An understanding of Privacy Legislation as it applies to the Clinical Trial Environment.

- Ability to work under pressure in a multi‑disciplinary team environment.

- Willingness to work in, and be supportive of, a positive and dynamic team culture.

- Ability to travel (desirable). Very minimal level of travel may be required (up to 10%).

Why Join Avance Clinical

- Be part of a rapidly growing, globally recognised CRO headquartered in Australia.

- Work with leading biotechnology and pharmaceutical partners.

- Supportive and collaborative work environment with opportunities for professional growth.

- Competitive salary package based on experience and qualifications.

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