Clinical Trial Project Manager

• BaCT Management and Team Members 
• Office of Cancer Research 
• Ethics Secretariat 
• Pharmacy 
• Laboratories 
• Coordinating / Principal Investigators 
• Study Coordinators and Research Nurses 

• Coordinating and Principal Investigators (C/PI) 
• Study Coordinators 
• Pharmaceutical / Biotechnology companies 
• Collaborative Research Groups 
• External safety and data monitoring committees 
• Medical practitioners 
• Pathologists 
• Clinical Trial Services providers e.g. Clinical Research Organisations (CROs) 
• Funding bodies (e.g. NHMRC, Cancer Council of Victoria) 
• International trials groups (e.g. EORTC) and overseas trial centres 
• Regulatory Authorities 

• Degree in Science, Health Information , Pharmaceutical or Clinical Research Organisation (CRO) experience 
• Experience in at least one of the following: 

1. clinical protocol and CRF development; 
2. clinical trial set-up, coordination and project management; 
3. Clinical trial data management and reporting. 

• Demonstrated understanding of Good Clinical Practice, regulatory, ethical, privacy and other relevant guidelines. 
• Project management skills including the ability to work with minimal supervision across multiple projects and tight timelines. 
• Excellent written and oral communication skills. 
• Ability to working as an effective member of a multi-disciplinary team. 
• Ability to engender cooperation and support from collaborators from diverse backgrounds and experiences. 
• Understanding of medical terminology. 
• Sound computer skills. 
• Willingness to travel interstate as required. 

• Sound knowledge and demonstrated experience using Microsoft Office Software Applications including Word, Access, Excel, PowerPoint and Outlook. 
• Understanding of oncology and/or haematology. 

1. Collaboration in Trial design & Set-up

• Develop project plan, metrics and timelines for new projects in collaboration with C/PI, biostatistics and data management.
• Coordinate and assist in the development, review and amendment of study protocols
• Coordination and project management of clinical trial operational, logistics and service provider requirements as required e.g. laboratory, pharmacy, CROs
• Develop study documentation in relation to data management and provide input for development of eCRF with Data Management
• Create Clinical Trial Management Plan and associated study manuals asrequired
• Review and approved essential documentation packages and request corrections (as required)
• Review ethics committee applications and approvals
• Ensure project team set-up sites and initiate studies in compliance with the protocol, regulatory and Good Clinical Practice (GCP) obligations, including making recommendations where warranted.
• Collaboration in the development of study budgets as required

2. Trial Conduct

• Manage multidisciplinary project teams, drawing on resources from within PeterMac and externally for duration of clinical trial.
• Manage daily activities on assigned projects as needed and supervise and mentor all project team members in their functions.
• Timely site selection and initiation according to schedule / timeline
• Oversight of registration and randomization of patients documentation as applicable
• Oversight and management of clinical trial safety reporting requirements as per protocol, relevant regulations and guidelines
• Ensure projects are conducted according to protocol, SOPs, applicable regulations and ICH GCP requirements.
• Trial monitoring and oversight conducted as per relevant study plans e.g. source data verification plan, data management plan, risk management plan.
• Timely turnaround of data queries according to data management plan.
• Liaison with study coordinators and clinicians at participating institutions, collaborative group organisations regarding study requirements
• Management and maintenance of Trial Master Files
• Inform C/PI of any concerns and immediately raise serious issues in writing
• Determine need for protocol amendment in collaboration with Investigator and statistics team
• Ensure projects proceed according to BaCT SOPs, applicable regulatory and GCP regulations.

3.Collaboration in trial analysis
 

• Timely completion of data cleaning activities for database lock and statistical analysis according to metrics
• Timely coordination of all final quality reviews of data, tissue, radiology and any others as per protocol.
• Comprehensive and timely archiving of all trial documentation and databases according to BaCT SOP

4.Project Management

• Be the primary contact for all communication on internal and external trial matters
• Effectively manage day to day operational aspects of trial conduct
• Facilitate and assist in the response to BaCT, client and regulatory audits / inspections
• Facilitate team and client meetings effectively
• All clinical trial documentation periodically reviewed for accuracy and completeness. All files kept up to date
• Maintain a working knowledge of GCP and BaCT SOPs.
• Assist with the provision of training as applicable.

5.Leadership and Engagement

• Work to foster good relationships and increase profile of BaCT within PeterMac and external parties
• Establish effective communication strategies fostering open and effective lines of communication at all levels.
• Assist in the leadership and conduct of specific projects as required.
• Contribute to study team meetings.
• Ensure clinical project management requirements are communicated.
• Provide regular detailed feedback regarding study status and data quality issues to study team using metrics to identify and improve processes.
• Facilitate effective use of reports to internal and external customers and report functionality.
• Identify and pursue local opportunities for professional and personal development