Senior Project Manager/Operations Lead
The Senior Project Manager / Operations Lead (SPM/OL) is responsible for strategy development, high quality project operations, team management and team development within CORE China. The SPM/OL will ensure studies are resourced effectively, managed efficiently, achieve project objectives within allocated budgets and agreed timelines and are conducted to the highest standards of Good Clinical Practice (GCP) if applicable, regulatory requirements and applicable Standard Operating Procedures (SOP). The SPM/OL also provides project mentorship/guidance to Project Managers (PM) and their teams, assisting in developing project knowledge across CORE China
The SPM/OL will report to the Managing Director GI China the Director Global Project Operations
The SPM/OL will have both functional and line management responsibilities for assigned Project Managers (PMs) and may have direct or indirect line management responsibilities and/or functional responsibilities for Senior Clinical Research Associate (SCRAs), Clinical Research Associate (CRAs), Senior Project Officer (SPOs), and Project Officers (POs). The SPM/OL will work closely with other PMs to provide and develop project expertise in order to deliver projects.
Duties and Key Responsibilities
- Coach/inspire team members in their role and responsibilities for project delivery and project team oversight, including providing technical guidance (where required), and being the point of issue escalation for PMs
- Develop and foster a collaborative team work approach across assigned projects, and the Research Services team more broadly
- Actively engage with implementation of the Centre for Operational and Research Excellence (CORE) strategic objectives and plans
Project Management & Technical Expertise
The SPM/OL is responsible for delivery of large and highly complex projects across the TGI. The level of complexity may be determined by the number of therapeutic areas involved, the size, budget and the locations/regions covered. The SPM/OL is also responsible to provide project management guidance and technical expertise to PMs.
- Lead development of project specific documents such as protocol and participant information forms as requested.
- Lead the feasibility planning and selection process of project sites
- Lead the establishment of study centres through
- Identify project specific activities that need to be out-sourced and be involved in the selection of suitable vendor/s.
- Deliver project specific milestones and budgets, and continuously monitor project progress to these timelines and budgets
- Manage the project(s) to ensure that all participating centres meet requirements
- Data quality, accuracy, completeness and timeliness
- Manage and supervise the monitoring visit schedules, and ensure carried out according to study design
- Oversee the on-going management of the participating sites to ensure adequate recruitment, data quality & timely CRF completion by investigators.
- Lead site monitoring and training, if required
- Oversee all project administration e.g. study management committee meetings, project newsletters etc.
- Work with the clinical team to ensure timely & successful completion of trial
- Oversee all study closeout visits
- Subject matter expert in clinical trials/research project management; engendering knowledge sharing across the project operations platform globally.
- Review and contribute to the development of the TGI Project Operations SOPs
- Support budget development and review for funding applications
Compliance and Training
- Mandatory attendance at department and project specific training
- Attend and actively participate in project management and organisational meetings and workshops
- Comply with all required project specific and TGI 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.
- Report and escalate identified issues in areas of responsibility according to TGI and/or project requirements
Skills, Knowledge and Experience
- At least 7 years’ experience in managing all aspects of complex clinical /research in an academic or pharmaceutical environment
- Extensive knowledge and experience of applying Research and Project Management principles
- Proven management experience of at least 5 years either as a line manager or project team manager
- Demonstrated experience in quality improvement
- Excellent abilities in written and verbal communication
- Tertiary qualifications in a related science or health care discipline and may have specialist qualifications
- Experience in managing NHMRC budgets and reporting requirements (or similar)
- Excellent working knowledge of ICH/GCP, ethical and regulatory requirements
- Excellent interpersonal skills to manage wide range of stakeholders
Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments.
We offer a flexible and inclusive work culture with excellent staff benefits including salary packaging arrangements and sound learning opportunities.
Type of career: Jobs
Application close date: 31/10/2021