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Senior Project Manager, Center for Clinical Investigation, Coordinating Center - Boston, United States - Partners HealthCare
Description
General Summary/Overview Statement:
The Coordinating Center Senior Project Manager for the Center for Clinical Investigation Coordinating Center (CCI-CC) will report to and work closely with the CCI-CC Director in the development, implementation, and management of the clinical trial operations for ongoing clinical trials and research consortiums.
The Project Manager will support the design, planning, and management of clinical trials. The primary study is the PETAL Consortium, an international multicenter observational study. The purpose of the is study is the Integration of machine learning and genomics to predict outcomes for newly diagnosed, relapsed and refractory mature T-cell and NK-cell neoplasms: a global study of the PETAL Consortium.
The goal is to maximize effective utilization of personnel and resources, while maintaining high levels of quality.
Principal Duties and Responsibilities:
Serves as a liaison between the PETAL Consortium investigators, REDCap, biostatistics team, BostonGene team and Ikigai Labs Team. This includes:
o Maintaining a list of all participating investigators, their research teams, legal contract teams and administrative teams, REDCap team, BostonGene and Ikigai Labs Team
o Organizing regular monthly meetings of the consortium members, setting up agenda ahead of the meeting, recording minutes at each meeting and taking key notes from each meeting including voting and consensus and following up on all discussions. Record action items and ensure execution and follow through.
o Developing a plan for all projects, proposals of the consortium on a regular basis and ensuring follow-up on all discussions, and requesting an update on projects on at least a bi-monthly basis
o Review new projects and LOIs with Steering Committee members and progress of each project with key investigators for each proposal
o Review data collection and quality of data collection with REDCap manager at each participating institution and ensure compliance
o Review regular upload of data onto Ikigai Labs platform by serving as liaison between REDCap data manager and Ikigai Labs personnel.
o Track progress and shipment of all archived material to BostonGene for NGS by serving as the liaison between BostonGene team, and pathology investigator and CRC of each participating institution
o Tracking payment as part of subcontracts made to each participating institution
Meet with the Research team regularly to review consortium projects and action items
Maintenance and update of the petal website with the web designer monthly
Updating and other websites monthly and as needed
Schedule and organize the PETAL Consortium Retreat/Symposium and semiannual meetings
Develop written materials for internal and external audiences in alignment with program and consortium goals
Contribute to the strategic development of the PETAL Consortium
Promote consortium efforts to collaborate with Marketing and Development in seeking gifts for PETAL Consortium
Contribute to and foster a team environment
Scientific writing activities will largely be comprised of organizing the workflow and coordination of investigators and CRCs performing components of larger research projects.
Facilitate the coordination of major translational research platforms, including but not limited to blood, plasma collection, liquid biopsy, and serial biopsy
Contribute to other strategic planning and special project oversight as requested
Contribute towards preparation of progress reports of the consortium and submission to sponsors
Research opportunities for collaboration with outside academic and industry entities
Operational Management
Works closely with the CC Director and Assistant Director to oversee a core group of staff who will manage and perform the following:
Regulatory
Develop and manage Investigators Brochure (if applicable)
Prepare and submit Investigational New Drug (IND) application and amendments (if applicable)
Prepare and submit IND Expedited Safety Reports (if applicable)
Prepare and submit IND Annual Progress and Safety Reports (if applicable)
Submit IRB Applications and required reporting
Manage site regulatory documents and Trial Master File (TMF)
Manage postings
Notification of study closure to FDA (if applicable)
Study documents
Assist in preparation of protocol and informed consent forms
Prepare Recruitment materials
Oversee preparation of Manuals of Procedures
Oversee site and staff training materials
Manage study portal and access to study documents and trial materials
Data management
Assist in developing Case Report Forms
Assist in development study conduct reports
Safety and Monitoring (as applicable)
Administer oversight committees such as Data Safety Monitoring Board
Develop Pharmacovigilance / Safety Monitoring plan
Review of safety data
Report SAE/SUSARS to IRB
Develop site initiation and monitoring plan
Conduct site initiation
Conduct interim monitoring
Conduct site close-out
Site activation, training, and trial conduct
Site feasibility assessment
Approve site activation
Provide site training and initiation
Investigation/remediation of site non-compliance
Study closure and analysis
Site closure and reporting
Monitor return / destruction of unused IP (if applicable)
Notification of study closure to IRB
Prepare and submit Final Study Report
Archival of site records including site TMF
Oversee publication of study findings
Quality and Process Improvement
Oversees development, implementation and administration of quality assurance. This includes continuous development of metrics and tools to monitor, trend, and report performance measures
Facilitates and/or participates in communication with internal and external staff as it relates to training, performance measures, and quality assurance
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