17/01 Babita Lukhar
HR Officer at The Gorge Institute for Global Health

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The George Institute - Project Manager/Senior Project Manager - Clinical Trials (4-5 yrs)

Anywhere in India/Multiple Locations/Delhi/Hyderabad Job Code: 23753

About The George Institute :

The George Institute for Global Health was established in 1999 with a mission to improve the health of millions of people worldwide, particularly underserved populations, by challenging the status quo and using innovative approaches to prevent and treat the world's biggest killers: non-communicable diseases and injury.

With offices in Australia, China, India and the UK, our 700+ people support 245+ active projects and clinical trials across 50+ countries, with 400+ more staff across our social enterprises. We focus on the global health challenges that cause the greatest loss of life, the greatest impairment of life quality and the most substantial economic burden, particularly in resource-poor settings.

Together with our academic partners, UNSW Sydney in Australia, Manipal Academy of Higher Education in India and Imperial College London in the United Kingdom, we work with a global network of collaborators, undertaking clinical, population and health systems research.

Our experts are among the most cited globally, bestowed accolades for excellence and innovation, and regularly participate in policy fora. Our research is published in leading academic journals, referenced in policy documents, and recognised for its excellence, innovation and impact. We are designated a WHO Collaborating Centre (WHO CC) for Injury Prevention & Trauma Care, and a WHO CC for Population Salt Reduction. Since 1999, we have raised more than $1 billion for research and produced over 10,000 peer-reviewed publications and other academic outputs.

What we do :

- Lead world-class, large-scale clinical trials, epidemiological studies and health systems research to transform treatments and healthcare delivery.

- Look beyond single diseases, across the life course, to identify patient-centred approaches to care that can be implemented at scale.

- Develop low-cost, innovative solutions to global unmet needs.

- Drive our global impact through a program of research, advocacy, thought leadership and disruptive social entrepreneurship.

For more information about The George Institute, visit www.georgeinstitute.org.

The George Institute India :

The George Institute, a wholly owned legal not-for-profit Indian research institute, has been conducting research related activities in India since 2002. The George Institute India's mission mirrors that of the parent organization, namely the discovery and implementation of solutions to chronic and disabling health problems through research, policy development and capacity building.

A number of large-scale projects in population, health systems and clinical research, funded by a diverse group of sponsors, both public and private, are conducted in India. The George Institute India comprises two distinct operating groups: Research and Development, and Infrastructure and Resources. It has two separate offices - in Hyderabad and New Delhi, where the research staff and senior management are based.

Context and Role :

The George Institute is seeking a highly skilled and experienced Project Manager/ Senior Project Manager to oversee the management of multiple clinical trials. The successful candidate will play a pivotal role in ensuring the successful execution of clinical research projects while also fostering the professional growth and development of early career staff through capacity building and training initiatives.

As a Project Manager/ Senior Project Manager, the candidate will have the opportunity to contribute to ground-breaking research and make a significant impact on global health outcomes.

Note: The specific requirements and responsibilities of the role may vary based on the needs of the George Institute and the nature of the clinical trial.

Reporting Relationships : Project Manager/ Senior Project Manager will report to Senior Research Fellow

Duties and Key Responsibilities :

Project Manager/ 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 investigators, clinicians, statisticians, data managers, and regulatory affairs personnel, to ensure smooth trial operations.

- Monitor trial progress, identify potential risks or issues, and 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.

The Project Manager/ Senior Project Manager should also :

- Provide mentoring and guidance to early career staff, 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 :

- Act as the primary point of contact for sponsors, investigators, and regulatory authorities, addressing their queries, concerns, and requests in a timely and professional manner.

- Participate in project meetings, prepare progress reports, and present updates to key stakeholders, including senior management and project sponsors.

- Facilitate the dissemination of trial findings and outcomes to relevant audiences, including scientific conferences, publications, and other knowledge translation platforms.

- Ensure direct reports understand and comply with GI's Policies and procedures, standard operating practices, ethical practice (with respect to research) and the legislative environment.

- Be responsible for managing performance of direct reports, including the completion of plans, and agreeing on work and personal objectives and reviewing such plans and objectives, in accordance with GI's Performance Management and Development Policy.

- Act as a role model and ensure the team's commitment to GI's values, ensuring direct reports perform to a high ethical standard and focus on integrity, collaboration, and teamwork in all efforts.

Work, Health and Safety :

- Comply with GI's Work Health and Safety Policy and related procedures, and similar policies which apply when visiting the premises of affiliates and collaborating sites.

- Promote and contribute to a safe, secure environment for staff and visitors.

- Ensure direct reports understand and comply with safe work practice and procedures.

Skills, Knowledge and Experience :

- Qualification : Advanced degree (e.g., MSc, MPH, PhD) in a relevant field, such as clinical research, public health, or life sciences, is highly desirable.

- A minimum of 5 years of experience in managing clinical trials, preferably in a research-intensive or academic setting.

- In-depth knowledge of clinical trial management principles, regulations, and industry best practices.

- Strong project management skills, including the ability to develop and execute project plans, manage resources, and monitor progress against objectives.

- Excellent leadership and communication skills, with the ability to collaborate effectively with diverse stakeholders and foster a team-oriented work environment.

- Experience in capacity building and training, particularly in mentoring and developing early career staff.

- Familiarity with relevant regulatory frameworks, such as International Conference on Harmonisation (ICH) guidelines and India regulatory requirements.

- 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.

- Excellent interpersonal skills with high level of proficiency in English and the ability to work well autonomously.

Note :

Our big and bold mission to improve the health of millions of people worldwide needs a diverse and innovative team to deliver it. So we foster a dynamic, inclusive and flexible workplace where each individual can bring their best selves to work.

Everyone is encouraged to apply, including people from culturally and linguistically diverse backgrounds, people with a disability, people of all gender identities and sexual orientations, and mature-aged adults.

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