Clinical Research Project Manager

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).