Senior Project Manager, Center for Clinical Investigation, Coordinating Center

Found in: Talent US C2 - 2 weeks ago

Boston, United States Mass General Brigham Full time
Senior Project Manager, Center for Clinical Investigation, Coordinating Center -(3279702)

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: 

oMaintaining a list of all participating investigators, their research teams, legal contract teams and administrative teams, REDCap team, BostonGene and Ikigai Labs Team

oOrganizing 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.

oDeveloping 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

oReview new projects and LOI’s with Steering Committee members and progress of each project with key investigators for each proposal

oReview data collection and quality of data collection with REDCap manager at each participating institution and ensure compliance

oReview regular upload of data onto Ikigai Labs platform by serving as liaison between REDCap data manager and Ikigai Labs personnel.

oTrack 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

oTracking 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:

·Develop and manage Investigator’s 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)

·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

·Assist in developing Case Report Forms

·Assist in development study conduct reports

·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 feasibility assessment

·Approve site activation

·Provide site training and initiation

·Investigation/remediation of site non-compliance

·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

All other duties as assigned

Qualifications

Qualifications:

Bachelor’s degree required, Master’s preferred At least 5 years of clinical research experience Ideally, minimum of 2 years working within an academic clinical trial coordinating center High proficiency with Microsoft Office, particularly with Excel

Skills/Abilities/Competencies Required:

Excellent interpersonal skills, with ability to interact all levels of the organization and foster collaboration

•Strong verbal and written communication skills

•Ability to proactively anticipate and identify issues/projects and initiate plans to address

•Self-motivated, independent and strong problem-solving skills

•Ability to successfully negotiate and collaborate with others of different skill sets, backgrounds and levels within and external to the organization

•Ability to document and communicate the status of progress against plans, taking corrective action as necessary

•Analytical skills necessary to comprehend complicated issues and formulate creative solutions for problem solving

  • Surgical Technologist

    Found in: Lensa US P 2 C2 - 4 days ago

    Boston, United States Boston Medical Center Full time

    POSITION SUMMARY:Responsible for overseeing two or more domestic and/or international research projects under the direction of senior managers/directors and Principal Investigators. The Research Project Manager will be responsible for the management of all aspects of one or more NIH-funded studies that will be implemented within Boston Medical Center's...

  • Surgical Technologist

    Found in: Lensa US P 2 C2 - 7 days ago

    Boston, United States Boston Medical Center Full time

    POSITION SUMMARY: Responsible for overseeing two or more domestic and/or international research projects under the direction of senior managers/directors and Principal Investigators. The Research Project Manager will be responsible for the management of all aspects of one or more NIH-funded studies that will be implemented within Boston Medical Center's...

  • Senior Clinical Trials Manager

    Found in: Appcast Linkedin GBL C2 - 1 week ago

    Boston, United States Clinical Dynamix Full time

    The Senior Clinical Trials Manager is responsible for leading the execution of clinical studies on schedule and on budget. Senior CTM level reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs. This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid...

  • Senior Clinical Trials Manager

    Found in: Appcast US C2 - 1 week ago

    Boston, United States Clinical Dynamix Full time

    The Senior Clinical Trials Manager is responsible for leading the execution of clinical studies on schedule and on budget. Senior CTM level reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs. This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid...

  • Phlebotomist with Processing Experience, Center for Clinical Investigation

    Found in: Talent US C2 - 1 day ago

    Boston, United States Mass General Brigham Full time

    Phlebotomist with Processing Experience, Center for Clinical Investigation-(3288060) Description GENERAL SUMMARY/ OVERVIEW STATEMENT: This position's hours will be Monday- Friday Days The CCI Lab Tech/Phlebotomists are at the front lines of customer services for the CCI and provide phlebotomy, processing, and medical assistant services, are...

  • Administrative Coordinator

    5 days ago

    Boston, United States Joslin Diabetes Center Full time

    Overview: The Administrative Coordinator provides administrative support for the Clinical, Behavioral & Outcomes Research and Pediatric Research areas. In the Clinical Research Center (CRC), the Administrative Coordinator is responsible for providing administrative support to the Senior Investigator of Clinical, Behavioral & Outcomes Research, the CRC Nurse...

  • Administrative Coordinator

    Found in: Talent US C2 - 1 week ago

    Boston, United States Joslin Diabetes Center Full time

    Overview The Administrative Coordinator provides administrative support for the Clinical, Behavioral & Outcomes Research and Pediatric Research areas.In the Clinical Research Center (CRC), the Administrative Coordinator is responsible for providing administrative support to the Senior Investigator of Clinical, Behavioral & Outcomes Research, the CRC...

  • Clinical Trial Manager

    1 week ago

    Boston, United States Clinical Dynamix Full time

    CTM OR Senior CTM, (DOE) *** Opportunity is full time permanent position or can be a contract to permanent role! The Senior Clinical Trials Manager / Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. Senior CTM / CTM levels reflect the experience, skill level, and capacity to manage larger...

  • Clinical Research Assistant, Cancer Center

    Found in: Talent US C2 - 1 week ago

    Boston, United States Mass General Brigham Full time

    Clinical Research Assistant, Cancer Center -(3284862) Description GENERAL SUMMARY/ OVERVIEW STATEMENT:Summarize the nature and level of work performed. The MGH Sample Processing Laboratory (SPL) provides services involved in preparing research samples obtained from patients enrolled in clinical trials of investigational cancer treatments for storage...

  • Administrative Coordinator

    Found in: Resume Library US A2 - 1 week ago

    Boston, Massachusetts, United States Joslin Diabetes Center Full time

    Overview: The Administrative Coordinator provides administrative support for the Clinical, Behavioral & Outcomes Research and Pediatric Research areas. In the Clinical Research Center (CRC), the Administrative Coordinator is responsible for providing administrative support to the Senior Investigator of Clinical, Behavioral & Outcomes Research, the CRC Nurse...

  • Senior Project Manager

    1 week ago

    Boston, United States IPM Integrated Project Management Company Full time

    Description Hybrid Relocation Assistance is Available For more than three decades, premier organizations have trusted IPM to lead the successful execution of their strategic portfolios and critically important initiatives. Headquartered in Chicago with offices in Boston, Parsippany, Minneapolis, St. Louis, Los Angeles, and San Francisco, IPM has led more...

  • Senior Project Manager

    2 days ago

    Boston, United States IPM Integrated Project Management Company Full time

    DescriptionHybridRelocation Assistance is AvailableFor more than three decades, premier organizations have trusted IPM to lead the successful execution of their strategic portfolios and critically important initiatives. Headquartered in Chicago with offices in Boston, Parsippany, Minneapolis, St. Louis, Los Angeles, and San Francisco, IPM has led more than...

  • Senior IT Project Manager

    7 days ago

    Boston, United States Boston Medical Center Full time

    POSITION SUMMARY: Under the direction of the ITS Project Management Office, the Senior Project Manager will plan, direct and coordinate activities surrounding major department or organizational project(s) and initiative(s) to ensure goals and objectives are met within prescribed time frame and funding parameters. Responsibilities include managing all phases...

  • Clinical Trial Project Manager

    2 days ago

    Boston, United States Medasource Full time

    Job Responsibilities: Project Management: On a daily basis, provides clear and consistent organization of each assigned trial’s status with strong attention to detail; this includes hands-on tasks such as tracking media received, inventory control, ensuring proper follow-up of pending project tasks, monitoring project timelines and associated reporting of...

  • Research Study Coordinator, Infectious Diseases

    22 hours ago

    Boston, United States Boston Medical Center Full time

    **Position**:Research Study Coordinator, Infectious Diseases **Location**:Boston, MA **Schedule**:40 hours per week, Hybrid (On-site 2-3 days per week) **ABOUT BMC**: At Boston Medical Center (BMC), our diverse staff works together for one goal — to provide exceptional and equitable care to improve the health of the people of Boston. Our bold vision to...

  • Senior Project Director

    Found in: Jooble US O C2 - 7 days ago

    Boston, MA, United States Hebrew Senior Life Full time

    Overview The Marcus Institute for Aging Research seeks a Senior Project Director to work in the Brain Stimulation and Home-Based Neuromodulation Program run by Dr. Alvaro Pascual-Leone and Dr. Bradley Manor. The mission of the program is to provide effective brain stimulation treatments to individuals with dementia within their home, to train clinicians in...

  • Clinical Research Coordinator I

    Found in: Resume Library US A2 - 1 week ago

    Boston, Massachusetts, United States Joslin Diabetes Center Full time

    Overview: The Clinical Research Coordinator I performs activities related to coordination and implementation of research protocols within the Beetham Eye Institute and Eye Research Section (both clinical trial and non-trial research).   The Clinical Research Coordinator I is responsible for ensuring quality adherence to protocol-specific and general...

  • Clinical Research Coordinator

    1 week ago

    Boston, United States Alcanza Clinical Research Full time

    Job Description Job Description Description Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in Boston and Northern MA, Portsmouth, NH, Charleston, SC, Charlotteville, VA, and Detroit, MI. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine,...

  • Clinical Trial Project Manager

    4 days ago

    Boston, United States Medasource Full time

    Job Responsibilities: Project Management: On a daily basis, provides clear and consistent organization of each assigned trials status with strong attention to detail; this includes hands-on tasks such as tracking media received, inventory control, ensuring proper follow-up of pending project tasks, monitoring project timelines and associated reporting of...

  • Clinical Trial Project Manager

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Boston, United States Medasource Full time

    Job Responsibilities: Project Management:On a daily basis, provides clear and consistent organization of each assigned trial’s status with strong attention to detail; this includes hands-on tasks such as tracking media received, inventory control, ensuring proper follow-up of pending project tasks, monitoring project timelines and associated reporting of...