Context and Role:
The Program Manager is responsible for the development, conduct and completion of research projects, particularly clinical trials and will be primarily responsible for the implementation of an appropriate quality plan for TGI India which will include quality support and advice, process development, project and process reviews with a focus on risk management and in line with the Global Quality Management Framework.
The Program Manager will report directly report to Director Global Project Operations and Research Manager
Duties and Key Responsibilities
- Attend relevant project specific meetings including formal kick-off meetings
- Develop project plan and other internal project management documents.
- Assist the Researchers in the development of project specific documents such as protocol and participant information forms as requested.
- Coordinate the feasibility planning and selection process of project sites
- Identify project specific activities that need to be out-sourced and be involved in the selection of suitable vendor/s.
- Contribute towards the study development and pilot.
Project Implementation and Closure
Manage the implementation, ongoing evaluation, prioritisation, reporting and timely delivery of all operational aspects of allocated project/s including:
- Contribute to the preparation of project specific budget where applicable
- Track budget for allocated portion of project.
- Develop and track the project scope
- Ensure that research is adherent to NHMRC ethical guidelines
- Work with relevant personnel to identify potential clinical sites, oversee or conduct feasibility through questionnaire, interview and/or site visit as applicable.
- Coordinate ethics submissions for individual recruiting sites.
- Complete ethics applications and regulatory applications for individual recruiting sites
- Review and negotiate site contracts with sites for agreement on wording and budgets.
- Oversee the set-up of sites in accordance with SOPs, protocol and all applicable regulatory guidelines.
- Contribute to the calculation of project staffing levels
- Line manage project staff
- Contribute to the identification of appropriate materials for project
- Conduct site monitoring and training
- Monitor project progress against timelines
- Deliver project specific milestones
- Coordinate project administration e.g. study management committee meetings, project newsletters etc
- Coordinate and drive internal project team to meet project specific deadlines.
- Liaise with centre staff to ensure effective local management
- Drive project team to deliver clean, accurate and verifiable data for interim and final analyses
- Develop project documentation e.g. site manuals, operating procedures etc
- Review and sign-off monitoring visit reports
- Ensure patient safety and adverse/serious adverse events are reported according to ethics committee and regulatory requirements
- Initiate filing conventions for the project and ensure the team is trained on requirements
- File and archive clinical project data at end of project
- Provide or contribute to progress reports for project originator and other stakeholders
- Maintain regular contact with project team
- Where applicable liaise with staff in Data Management and Statistics Divisions on project specific deliverables
Quality Processes and Risk Management
- Develop and implement a TGI India Quality Processes and Risk Management Plan, using the Global Quality Management Framework
- Quality Assurance (QA) support and oversight of TGI India projects and functional areas to promote quality outcomes and regulatory compliance by undertaking an initial project review and final project review
- Implement the global project risk management process in TGI India including reporting and escalation procedure
- Provide and/or oversee Vendor assessments in TGI India
- Implement process improvement plan and activities in line with the Global Quality Management Framework
- Ensure that new content is added to Project Operations site on SharePoint at a country and global level
Compliance and Training
- Mandatory attendance at core department and project specific training
- Attend and actively participate in project management and organisational meetings and workshops
- Comply with all required project specific and George Institute specific systems.
- Comply with all applicable regulations, guidelines, SOPs and project specific requirements. Complete and document all necessary training in the allocated system/form.
- Ensure project team members have access to necessary project specific training
- Contribute ideas and experiences so that improve processes, tools, systems and organisation.
Skills, Knowledge and Experience
- Tertiary qualifications in a related science or health care discipline
- Relevant experience in project management with a minimum of 2-3 years’ experience in a senior operational role in a clinical research environment
- Knowledge of ICH-GCP guidelines, global and local ethical and regulatory research requirements
- Knowledge of risk management strategies, experience with financial and operational risk overview within a health research environment
- Proficient in use of the Microsoft office suite of products including word, excel, powerpoint and outlook
- Strong problem solving, analytical skills, and strategic thinking
- Strong leadership and mentoring skills
- Excellent interpersonal skills and the ability to work well and flexibly ie autonomously, in small teams and with a wide range of varying stakeholders
- Ability to see the big picture, yet still focus on detail
- Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments.
- Strong focus on quality of work
- Ability to travel
How to apply:
Interested candidates should send their resume with full contact details, clearly mentioning the job title 'Program Manager' in the subject line to firstname.lastname@example.org by the 25 August 2019.
‘George Institute for Global Health is an equal opportunity employer.
We embrace diversity and do not discriminate on account of race, caste, ethnicity, colour, religion, nationality, sexual orientation, gender identity, age, physical or mental disability or other non-merit factor. We are committed to creating an inclusive workplace, where we value individual differences and make people feel welcome, accepted and that they belong’.