Sr. Project Manager
George Clinical has over fifteen years’ experience providing full CRO services for biotech, medical research institutes and mid-to-large sized pharmaceutical companies. George Clinical has headquarters in Sydney Australia and vast experience in the Asia Pacific Region. George Clinical US was established through acquisition in May 2017 and has substantial expertise in oncology clinical trials including early phase.
A significant point of differentiation is George Clinical’s relationship with its parent company, The George Institute for Global Health. The George Institute, is a global leader in chronic disease research, with extensive global investigator networks.
About the Role:
The Senior Project Manager (SPM) is responsible for overseeing and coordinating all study management activities. The SPM works closely with the sponsor, vendors, investigators, and appropriate staff in each department of George Clinical to launch and complete the study deliverables. The SPM will oversee all functional areas involved with their assigned projects per SOW and have responsibility for timelines and budget adherence with each trial. The SPM will oversee site management as an important part of their role, and may be involved in the performance of site qualification, site initiation, co-monitoring and/or close-out visits as needed. The SPM may be responsible for mentoring junior clinical operations staff as needed. The SPM may be called upon to support proposal development and present at bid defense meetings as well as lead related meetings during the bidding process. On occasion, SPM will be requested to perform additional activities at a Program Management level as well as work with senior members of Clinical Operations to develop/review workflows, tools, and SOPs. The SPM is responsible for leading any and all assigned teams while demonstrating professional demeanor and maintaining confidentiality in all interactions with both internal and external contacts. SPM work is performed under the general direction of the Senior Director, Clinical Operations, though it is expected the position requires minimal oversight and support (unless escalation is needed) once SPM is fully on-boarded with George and/or has completed all transition activities for this senior level role.
- Provide strong, independent Clinical Operations leadership on assigned and/or complex projects
- Communicate effectively and efficiently with clients, vendors, and internal team
- Establish team roles and responsibilities and Provide clear direction to internal team and vendors to ensure study success
- Serves as primary contact with clients and vendors, establishing communication mechanism and formats that meet the needs of all parties supporting the trial
- Participate in development and strategizing on any proposals or bids to external customers
- Ability to manage and execute complex trials, including timeline development, taking on a strategic role with the client if needed, and developing customized processes, materials, and/or plans to support trial needs
- Ensure projects are adequately staffed according to budget, SOW, and capabilities, and escalate to management when issues are present or anticipated that will require modifications
- Manage protocol and ICF development as applicable.
- Oversee and ensure George site selection process is successful through oversight of feasibility questionnaire development, management of workflow, and reviewing record of processes managed by the assigned clinical staff
- Design and implement study specific project plans, logs, and actions to keep project on track
- Oversee and ensure delivery of timely project deliverables for all functional areas of the project
- Mitigate risks where and when needed to ensure project success
- Ensure George or sponsor selected vendors are adequately supported from contracting through training /onboarding, and throughout the trial
- Manage all study specific vendors contracts as applicable (per project scope and George contract scope)
- Manage study-related vendor deliverables per SOW and study timelines
- Ensure adequacy of CRF design and development for the trial
- Close oversight of site management team activities from site startup through closeout. Depending on the study, SPM may be involved directly interim calls to site and troubleshooting as needed. Work with the Clinical Trial Manager, CRAs, and CTSs to ensure protocol training, site protocol adherence and query resolution is adequately supported.
- Maintain project financial health through review of monthly activities against current SOW, and addressing change orders in a timely manner
- Maintaining scope change log and execution Change Orders / Budget Amendments as needed.
- Prepare and maintains project financial workbook each month, including forecasting updates from study start through closure
- Assists with ongoing review of data during trials, as needed
- Continues to develop processes with the growth of the area and incorporate those processes with other departments
- Assists in developing relationships with new and existing clients
- Communicate / escalates project risks to Project Director and/or direct report (line manager) as appropriate
- Ensure team members are adequately trained on the project to perform their assigned tasks and services.
- Oversee adequacy of trial master file setup and maintenance is maintained throughout the trial by assigned team members.
- Ensure data deliverables are complete and current throughout the trial through regular review of data management reports, review of monitoring activities, and site management reports (as applicable)
- Ensure clients are provided with trackers, reports, and logs as needed and on time per SOW
- Develop and deliver dashboards and Executive Summary Reports as required by clients and per SOW
- Ensure compliance with all applicable regulations, SOPs, contracts/agreements, and project plans,
- Mentor / coach junior team members as needed to support their success as well as to ensure the trial success. This level of support may include support / attendance at select Site Qualification, Site Initiation, Interim and Close-out Visits, and may be especially important for early phase trials to support client expectations.
- Coordinates and participates in internal and external project team meetings as needed
- Participates in company, staff, and departmental meetings
Skills, Knowledge and Experience
- CRA or site management experience and bachelor’s degree strongly preferred. Oncology project management experience required. Five to seven years of oncology Project Management experience and/or training; OR equivalent combination or education and experience in oncology and project management related roles.
- Must have exceptional communication skills in both verbal and written form
- Must have excellent organizational and time management skills
- Must have an understanding of GCP’s and regulatory requirements of the FDA
- Must be skilled in the area of delegation and task follow-up
- Must have experience with the following software: Word, Excel, Power Point and Adobe Acrobat
- Must be able to prioritize multiple projects and coordinate these efforts
- Must be able to maintain confidentiality of information and procedures developed
- Must be able to work on complex projects involving various research and ancillary entities
- Must be able to promote a positive, productive, and partner-oriented customer service attitude with clients
- Maintain professional, positive, and motivational working relationships with staff, vendors, and clients as representative of George team leadership principles
- Ability to sit, stand, walk, reach, climb or balance, stoop or crouch, hand/wrist use, talk, see, and hear for extended period to time. Extended periods of PC time.
- Ability to lift up to 25 lbs.
- Travel may be required