Vice President Research

The group exists to provide professional consulting, implementation and project management services to clients to enable the delivery of consulting services specific to the conduct of clinical trials and to internal customers to inform the design, development, sale, support and implementation of clinical research software as complete solutions or as part of solutions.

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

The Vice President, Research will lead projects, project teams, project delivery and governance for external client projects allocated to them. For internal clients, the Vice President, Research will support project teams and provide domain expertise as needed as Anova identifies, designs, develops, sells, implements and supports its technology solutions. The role will provide advice regarding the conduct of human research in all of its forms (e.g., clinical trials, investigator-initiated trials, compassionate use) following regulation and guidance, monitoring and quality assurance, advocacy and education with respect to programs, projects, and their delivery, to clients and staff at all levels.

Activities include providing oversight, building, and working closely with project teams to proactively identify and avoid or solve potential barriers to successful project delivery, development and tracking of KPIs, providing oversight of the quality management, and the creation of innovative solutions designed to maximize efficiencies and productivity to achieve study sponsor's short-term and the long-term objectives. 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.

The role will provide financial oversight of program budgets as agreed with Anova clients. This position will serve as the primary contact to the Sponsor for all development programs managed and delivered by Anova and will work closely with other functional department heads to enable continued growth of the business.

Responsibilities

Clinical Trial Project Management

• Lead Anova wide approach to Project Management including resource planning and management, preparing resource plans and the monitoring and reporting of project outcomes;
• Provide strategic input into clinical trial/Sponsor proposals, crafting innovative new approaches and program designs;
• Lead the implementation, management and successful delivery of Sponsor portfolio, programme and project governance frameworks.;
• Establish and lead organisation wide clinical trial project reporting with a focus on value added advice and early identification, avoidance and resolution of risk and issues;
• Develop clinical trial portfolio prioritization methodologies;
• Coach and mentor Clinical Research Project Managers, Sponsors andother clinical trial team members;
• Lead the review of clinical trial programs and projects for deliverability including adequate resourcing, management and governance procedures, and accuracy of financial estimates;
• Lead sponsor study start-up process, ensuring project plans are in place and operational for each project;
• Lead the procurement of programme and project management services.
• Build and maintain strong effective relationships with the Sponsor as well as staff throughout Anova;
• Participate in client meetings and bid defences providing operational and strategic input.

AnovaOS Programme

• Support effort on continuous evaluation of processes to identify inefficiencies and remediate issues to ensure and maintain company's competitive advantage, including working with AnovaOS product teams to inform development roadmap to address inefficiencies;
• Support the development of standardized solutions, core processes and metrics for all assigned AnovaOS programs;
• Ensure regulatory compliance of all AnovaOS operations;
• Provide appropriate clinical/strategic input to company technology development decisions;
• Provide strategic input into technology proposals, crafting innovative new approaches and program designs;
• Coordinate and prepare clear and effective communications.

Clinical Trial Project Compliance & Quality

• 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 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;
• Contribute to the creation of 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.

People & Relationship Management

• Provide supportive leadership, motivating and directing staff as they work:
• Effectively communicating current activities and policies;
• Managing external contractors, consultants, projects, project teams, and managing the quality and timeliness of outputs;
• Provide mentoring support for Clinical Trial Project Managers;
• 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.

Qualifications

• Bachelor’s degree level qualification in Life Sciences, Nursing Licensure or Pharmacy, at minimum;
• Project management qualification including PMO or PRINCE2 practitioner (or equivalent);
• Understanding of change management principles.

Experience

Minimum of:

• 10 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);
• Research site/site network management experience preferred;
• Understanding of clinical and/or clinical research technology programs;
• Experience in early phase trials (Phase I-II) and FIH trials.