Clinical Research Project Manager

Anova has adopted a project management approach to its planning, prioritisation and delivery of projects/programs.

The Clinical Research Project Manager will lead project delivery and governance for internal and external client projects allocated to them. The role will provide regulatory advice and guidance, monitoring and assurance, advocacy and education with respect to programs, projects, and their delivery, to clients and staff at all levels.

Additionally, this will include a reporting framework focussed on value added advice and early identification of risk and issues for all programs and projects allocated to them.

Key Responsibilities

Clinical Research Project Management

• Proactively manage project level operational aspects of clinical trial and compassionate use programs for Anova clients including management of timelines, budgets, resources and vendors;


• Provide updates on project progress to internal and external program leads;


• Lead sponsor study start-up process, ensuring project plans are in place and operational for each project;


• Work proactively with internal and external teams to set priorities in accordance with applicable project plans, company SOPs, ICH/GCP guidelines and regulatory requirements;


• Ensure all project level program and study documentation is developed and maintained in accordance with company SOPs;


• Contributes to relevant study documentation including clinical protocols, clinical study reports, regulatory submissions as well as operational plans;


• Participates in study data review and other review activities as assigned;


• Liaises with sites, physicians, patients and representatives in the conduct of research and/or compassionate use programs;


• Provide support to site teams and physicians in the conduct of research programs;


• Other duties as assigned.

Anova-wide Project Management

• Support the implementation and management of portfolio, programme and project governance frameworks and development of appropriate reporting tools which deliver value;


• Participation in Anova wide approach to Project Management including resource planning and management, preparing resource plans and the monitoring and reporting of project outcomes;


• Support organisation wide project reporting with a focus on value added advice and early identification and resolution of risk and issues;


• Coach and mentor project sponsors and managers;


• Review programs and projects for deliverability including adequate resourcing, management and governance procedures, and accuracy of financial estimates;


• Support the procurement of programme and project management services.

People & Relationship Management

• Effectively communicating current activities and policies;


• Managing external contractors, consultants, projects, project teams, and managing the quality and timeliness of outputs;


• Establish and maintain close working relationships with internal and external contacts including project managers, staff, suppliers, consultants, and contractors;


• Influence internal stakeholders to achieve the desired outcomes, including process improvement, of the PMO and Anova.

Education

• Bachelor’s degree level qualification in Life Sciences, Nursing Licensure or Pharmacy, at minimum;


• Project management qualification including PMO or PRINCE2 practitioner preferable;


• Understanding of change management principles.

Experience

Minimum of:

• 5 years’ experience as a clinical operations or project manager at a sponsor or CRO company is preferred;


• Therapeutic experience in complex disease (oncology, rare disease, infectious disease, cardiology, neurology);


• Understanding of clinical and/or clinical research technology programs (preferred);


• Experience in all phases of clinical trials including early phase trials (Phase I-II) and FIH trials (preferred).