Project Manager

Context and Role

Non-communicable diseases (NCDs) cause over 70% of all deaths worldwide each year. 85% of premature deaths due to NCDs are in low- and middle-income countries. The George Institute is focused on finding better treatments for the worlds biggest health problems including renal and cardiovascular diseases.

We are conducting large-scale clinical trials, often across multiple countries and clinical sites, and developing new medicine and technology solutions to prevent and treat common chronic and critical conditions with a global perspective.

Our work is transforming practice and improving health outcomes worldwide. A Project Manager will work on trials testing new and existing drugs and will typically be involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring and closing down the trial.

Reporting Relationships

Directly reports to Senior Project Manager

Duties and Key Responsibilities

The Senior Project Manager would be expected to:

• Oversee the planning, implementation, and execution of multiple clinical trials conducted by the George Institute.
• Develop and manage comprehensive project plans, including timelines, milestones, resources, and budgets, ensuring adherence to all relevant regulations and protocols.
• Coordinate with cross-functional teams, including sponsors, investigators, clinicians, statisticians, data managers, and regulatory affairs personnel, to ensure smooth trial operations.
• Monitor trial progress and identifies potential risks or issues.
• Implement appropriate mitigation strategies to ensure trial objectives are achieved.
• Ensure compliance with regulatory requirements, ethical standards, and Good Clinical Practice (GCP) guidelines throughout the trial lifecycle.
• Collaborate with external partners, including academic institutions, pharmaceutical companies, and other stakeholders, to foster productive collaborations and leverage available resources.
• Provide mentoring and guidance to early career staff (CTAs, and CRAs), assisting them in their professional development and career progression.
• Conduct training sessions and workshops on clinical trial management best practices, protocols, regulatory requirements, and other relevant topics.
• Develop and maintain training materials, standard operating procedures (SOPs), and other resources to support the training and development initiatives.

As a Team Member:

• Participate in team meetings and activities relating to the Leprosy trial and own work area;
• Participate in special projects to improve processes, tools, systems and organisation;
• Take responsibility for personal learning and development and for setting achievable and meaningful work objectives and managing personal targets, meeting obligations of the Institutes Performance Management and Development Policy;
• Demonstrate commitment to GIs values, including performing to an exceptionally high ethical standard and focus on integrity, collaboration and teamwork in all efforts.

Work, Health and Safety

• Comply with Work Health and Safety legislation and operate in accordance with established Occupational Health and Safety practice and procedures at the Institute.
• Promote and contribute to a safe, secure environment for staff and visitors.

Skills, Knowledge and Experience

• Qualifications: Qualification in life sciences, medical sciences or nursing with;
• Experience of at least 4 years in clinical trial management;
• Strong understanding of ICH-GCP, local regulatory requirements (CDSCO and HMSC), and clinical trial operations;
• Demonstrated experience managing multi-site, multi-country clinical trials, with full responsibility for timelines, budgets, and deliverables.Strong problem solving, analytical skills, and proven strategic thinking;
• Experience working in a cross-functional environment with internal and external stakeholders (sponsors, vendors, investigators, and site staff);
• Familiarity with tools such as CTMS, eTMF, and EDC systems; experience with risk-based monitoring approaches is an advantage;
• Demonstrated resourcefulness, with ability to influence others to achieve common goals;
• Excellent interpersonal skills with high level of proficiency in English and the ability to work well autonomously;
• Excellent team-workskills, with demonstrated ability to collaborate in small teams and with a wide range of varying stakeholders;
• Ability to demonstrate flexibility and to be adaptable to changing organisational priorities and ambiguous environments;
• Strong focus on producing the highest quality of work and on ensuring optimum accuracy of outputs;
• Well organised and efficient, with the capacity to work under pressure.