Clinical Project Manager

4 months ago

Boston, United States Inozyme Pharma Full time

Clinical Project Manager / Sr. Clinical Project Manager


The Clinical Project Manager / Sr. Clinical Project Manager (CPM) provides operational leadership of one or more clinical trials from protocol development through clinical study report, and ensure activities are executed in accordance with the protocol, ICH/GCP guidelines, applicable regulations, and company's policies and procedures and corporate goals. Responsibilities may include leading cross-functional study team(s) and/or the oversight of Contract Research Organizations (CRO) and vendors. The CPM will have a command of assigned studies, the ability to flex and adapt to dynamic situations, and will utilize critical thinking skills to facilitate risk mitigation analyses and problem solving.


Reporting Relationship


The Clinical Project Manager or Sr. Clinical Project Manager will report to the Vice President of Clinical Operations or designee


Duties and Responsibilities


  • Lead cross-functional teams to ensure studies are conducted one time, with quality and within budget
  • Develop and maintain study timelines through collaboration with internal and external stakeholders; ensure timelines remain on track through ongoing communication, collaboration and risk-mitigation strategies
  • Drive study start-up activities, including site and vendor identification, feasibility and selection
  • Effectively model and manage patient enrollment forecasts; implement risk mitigation strategies to ensure enrollment remains on track
  • Develop oversight plans for outsourced services; oversee vendors, including CROs, third-party vendors and consultants to ensure the timeliness and quality of services performed
  • Partner with CMC/clinical supplies to calculate drug projections and contribute to design and packaging of study supplies
  • Oversees monitoring and monitor performance, including adherence to the monitoring plan and applicable SOPs
  • Conduct monitoring oversight visits and site engagement visits to ensure the quality of vendor and site performance
  • Ensure effective and timely contract and budget negotiations with clinical sites and vendors
  • Lead and/or contribute to study risk assessment and risk mitigation. Proactively communicate risks to study members and senior staff.
  • Oversee the management of the electronic Trial Master File (TMF); ensure the TMF is created, maintained, monitored and closed out in accordance with the TMF plan and study timelines
  • Facilitate and manage cross-functional interactions with internal and external stakeholders to ensure relevant and timely communication of information and materials for decision making purposes as well as ensure adherence to study timeline.
  • Collaborate with medical research, data management, biostatistics, pharmacovigilance, and other functions to ensure data is processed in a timely manner for ongoing data review, interim analyses and final database lock.
  • Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, DSURs, monitoring plans and reports.
  • Review and approve corrective action plans, participate in study-related audits.
  • Actively contribute to and implement best practices and standards for study management; participate in the development of initiatives and process improvement within Clinical Operations
  • Approach problem solving with a strategic, action oriented and positive attitude.
  • Manage/mento/train junior staff by actively participating in documentation, sharing industry standards, implementation of trial conduct best practices, and lessons learned
  • Assist with the development of policies, procedures and best practices in support of operational excellence
  • Other duties as assigned.


Educational Qualifications


A Bachelor's degree or higher degree (scientific discipline preferred)


Additional Qualifications


  • 4-7 years in trial management with a sponsor company managing various phases of clinical trials.
  • Experience overseeing vendors, including identification and mitigation of risks.
  • Experience leading cross-functional teams and meetings.
  • In-depth understanding of ICH/GCP guidelines and FDA regulations.
  • Understanding/working knowledge of Microsoft Word and Excel and Microsoft Project.
  • Critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive study(ies) and understand implications of decisions that affect study outcomes and timelines.
  • Strong interpersonal and negotiation skills.

  • Project Manager

    4 weeks ago

    Boston, Massachusetts, United States Alliance for Clinical Trial in Oncology Foundation Full time

    About the RoleThe Alliance for Clinical Trials in Oncology Foundation is seeking a highly skilled Project Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for managing the development, implementation, and oversight of assigned clinical trials.Key Responsibilities:Manage the development, implementation,...

  • Senior Clinical Trial Manager

    2 months ago

    Boston, United States Clinical Dynamix Full time

    Senior Clinical Trial ManagerDescriptionReporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with...

  • Senior Clinical Trial Manager

    2 months ago

    Boston, United States Clinical Dynamix Full time

    Senior Clinical Trial ManagerDescriptionReporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with...

  • Senior Clinical Trial Manager

    1 month ago

    boston, United States Clinical Dynamix Full time

    Senior Clinical Trial ManagerDescriptionReporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with...

  • Clinical Project Manager

    2 weeks ago

    boston, United States Inozyme Pharma Full time

    Clinical Project Manager / Sr. Clinical Project ManagerThe Clinical Project Manager / Sr. Clinical Project Manager (CPM) provides operational leadership of one or more clinical trials from protocol development through clinical study report, and ensure activities are executed in accordance with the protocol, ICH/GCP guidelines, applicable regulations, and...

  • Clinical Project Manager

    1 month ago

    boston, United States Inozyme Pharma Full time

    Clinical Project Manager / Sr. Clinical Project ManagerThe Clinical Project Manager / Sr. Clinical Project Manager (CPM) provides operational leadership of one or more clinical trials from protocol development through clinical study report, and ensure activities are executed in accordance with the protocol, ICH/GCP guidelines, applicable regulations, and...

  • Clinical Project Manager

    1 month ago

    Boston, United States Inozyme Pharma Full time

    Clinical Project Manager / Sr. Clinical Project ManagerThe Clinical Project Manager / Sr. Clinical Project Manager (CPM) provides operational leadership of one or more clinical trials from protocol development through clinical study report, and ensure activities are executed in accordance with the protocol, ICH/GCP guidelines, applicable regulations, and...

  • Clinical Trial Manager, Start Up

    2 months ago

    Boston, United States Clinical Dynamix Full time

    Clinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...

  • Clinical Trial Manager, Start Up

    2 months ago

    Boston, United States Clinical Dynamix Full time

    Clinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...

  • Clinical Trial Manager, Start Up

    2 months ago

    boston, United States Clinical Dynamix Full time

    Clinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...

  • Senior Clinical Trial Manager

    2 weeks ago

    Boston, MA, United States Clinical Dynamix Full time

    Senior Clinical Trial ManagerDescriptionReporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with...

  • Clinical Trials Project Manager

    4 weeks ago

    Boston, Massachusetts, United States NuvoAir Full time

    Clinical Trials Project ManagerNuvoAir is seeking a highly skilled Clinical Trials Project Manager to join our team. As a Clinical Trials Project Manager, you will be responsible for managing multiple projects ranging in size and complexity from single to multi-center studies.Key Responsibilities:Manage multiple projects from start to finish, ensuring timely...

  • Clinical Trial Project Manager

    3 weeks ago

    Boston, United States Massachusetts General Hospital Full time

    Description The Neurological Clinical Research Institute (NCRI), at the Massachusetts General Hospital (MGH) is a premier Academic Clinical Research Organization (CRO) managing clinical trials in neurological disorders. The NCRI employs physician clinical researchers, research nurses, project managers, data managers, SAS programmers, systems analysts, grants...

  • Clinical Research Project Manager

    4 weeks ago

    Boston, Massachusetts, United States Massachusetts General Hospital(MGH) Full time

    Job Summary:The Massachusetts General Hospital (MGH) is seeking a highly organized and intellectually curious individual to serve as a Project Manager within the Infectious Diseases Clinical Research Unit (ID CRU). The successful candidate will work with a multidisciplinary team to oversee research activities, manage projects, and contribute to the...

  • Senior Project Engineer

    4 weeks ago

    Boston, Massachusetts, United States Project Farma Full time

    Why Precision for Medicine?Welcome to the forefront of innovation in cutting-edge patient treatments. As a leader within the life science industry, we are constantly pushing the boundaries of what is possible and redefining the standards of excellence.Our dynamic team is composed of vibrant professionals who are passionate about delivering high-quality work...

  • Clinical Dynamix | Senior Director or Executive Director, Program Management

    22 hours ago

    boston, United States Clinical Dynamix Full time

    How you’ll contribute:Across one or more clinical stage programs, partner with Program Team Lead (PTL) to generate and deliver best-in-class development timelines on budget, and to outstanding quality. Proactively identify key risks and mitigations.In partnership with the PTL, the PM is accountable for timely execution of all program activities on the...

  • Clinical Dynamix | Senior Director or Executive Director, Program Management

    2 days ago

    boston, United States Clinical Dynamix Full time

    How you’ll contribute:Across one or more clinical stage programs, partner with Program Team Lead (PTL) to generate and deliver best-in-class development timelines on budget, and to outstanding quality. Proactively identify key risks and mitigations.In partnership with the PTL, the PM is accountable for timely execution of all program activities on the...

  • Clinical Project Manager

    2 weeks ago

    Boston, MA, United States Inozyme Pharma Full time

    Clinical Project Manager / Sr. Clinical Project ManagerThe Clinical Project Manager / Sr. Clinical Project Manager (CPM) provides operational leadership of one or more clinical trials from protocol development through clinical study report, and ensure activities are executed in accordance with the protocol, ICH/GCP guidelines, applicable regulations, and...

  • Clinical Trial Manager, Start Up

    2 weeks ago

    Boston, MA, United States Clinical Dynamix Full time

    Clinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...

  • Clinical Research Project Manager, Men's Health

    4 weeks ago

    Boston, Massachusetts, United States Partners HealthCare Full time

    Job Summary:The Clinical Trial Project Manager will oversee study recruitment and retention activities for federal and industry-sponsored clinical trials across a wide range of therapeutic areas. This role will work closely with study PIs and other research team members to develop and implement study-specific recruitment strategies to meet planned enrollment...