Clinical Project Manager

3 months ago

Boston, United States Anteris Tech Full time
Job DescriptionJob DescriptionSalary:

Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are developing the first-in-class biomimetic TAVR valve as a growing and inclusive Medtech team with global office locations in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia. Help us build a team that will shape the future of TAVR.


The Clinical Project Manager will be a key member of a team that is developing a clinically-superior THV and delivery system by managing the operational activities of clinical studies. This individual will plan, develop, and follow systems and procedures to ensure optimum compliance in accordance with GCP / ICH guidelines and FDA regulations, ensure operating quality and efficiency, and work closely with Medical Affairs, R&D and Regulatory departments to execute clinical trials. 


In this role, you will engage and work closely with CROs, the Core Labs and DSMBs / CECs and other vendors to execute on Anteris’ clinical trials.  The CPM will engage with the study sites to ensure smooth and compliant study execution.


Main Responsibilities:


  • Responsible for comprehensive study management for clinical studies to include but not limited to CRFs and database development, site management, and project planning.
  • Chair core team meetings for assigned studies ensuring goals and deliverables are clearly defined, and issues, decisions, risks, and actions are appropriately tracked.
  • Responsible for project development & performance tracking and risk management
  • Responsible for vendor oversee (CRO, core labs etc) to ensure project timelines and budgets are achieved.
  • Maintain compliance to company standard operating procedures (SOPs) and applicable regulations.
  • Oversee and contribute to development of key study documents including, but not limited to study protocols, protocol amendments, study plans and procedure manuals, project tools, informed consent forms and clinical study reports.
  • Oversee and as needed directly assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical study subject documentation is within parameters of study hypothesis, as well as monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory requirements.
  • Accountable for conducting clinical research programs in accordance with approved project plan, compliance to company standard operating procedures and applicable regulations.
  • Provide Quality Assurance support and management level representation during audits and inspections.


Skills, Knowledge, Experience, Qualifications:


  • Bachelor of Science in a scientific degree program or related medical/scientific field required; graduate degree preferred.
  • Minimum of five years’ experience in clinical research with at least two years in the medical device industry in a project leadership role.
  • Direct experience successfully conducting cardiovascular class III devices IDE and registry studies to align with business objectives; experience in structural heart devices preferred.
  • Expertise with GCP and regulatory compliance guidelines for clinical trials required.
  • Experience with site- and sponsor-level FDA BIMO investigation(s).
  • High attention to details and accuracy; excellent prioritization, organizational skills, and metric-driven project management skills.
  • Ability to work effectively on cross-functional teams.
  • Certified Clinical Research Professional (CCRP) and/or Project Management Professional (PMP) preferred.
  • Positive, self-starter, willing to work in an extremely fast-paced environment looking for growth and making a difference in patient lives.
  • Excellent communication and presentation skills.
  • ~30% travel to study sites, vendors and conferences.


Preferred Location:  Boston, MA

Optional Location:  Minneapolis, MN


What We Offer:

 

  • Opportunities to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
  • Collaborative and dynamic work environment with a culture of innovation and excellence.
  • Competitive compensation package, including salary, performance-based bonuses, and stock options.
  • Career development opportunities and a chance to be part of a growing company that values its employees.

 

Health and Wellness Offerings:

 

  • Medical, Dental, and Vision Offerings
  • Flexible Spending Account (FSA)
  • 401k + Company Match
  • Life, AD&D, Short Term and Long-Term Disability Insurance
  • Bonus Plan Eligibility
  • Employee Stock Option Plan
  • Paid Holidays & Vacation
  • Employee Assistance Program
  • Inclusive Team Environment

 

 

 

clinical research



remote work

  • Project Manager

    2 weeks ago

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

    About the RoleWe are seeking a highly skilled and experienced Project Manager to join our team at the Alliance for Clinical Trials in Oncology Foundation. As a Project Manager, you will play a critical role in the development, implementation, and oversight of assigned clinical trials.Key ResponsibilitiesManage the development, implementation, and oversight...

  • Associate Director, Clinical Data Management

    2 weeks ago

    boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    2 weeks ago

    boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    3 months ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    3 months ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Clinical Trial Manager, Start Up

    2 weeks 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 weeks 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 weeks 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...

  • Project Manager

    2 months ago

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

    Job DescriptionJob DescriptionThe Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the...

  • Clinical Project Manager

    4 weeks ago

    Boston, United States Anteris Tech Full time

    Job DescriptionJob DescriptionSalary: Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are developing the first-in-class biomimetic TAVR valve as a growing and inclusive Medtech team with global office locations in Minneapolis, MN, US; Geneva,...

  • Clinical Project Manager

    7 days ago

    Boston, United States Albion Rye Associates Full time

    Job Title: Clinical Project Manager Location: Boston, MA Company: Rare Disease Biotech Employment Type: Full-time   Position Summary: Our client are an innovative biotech company focused on developing breakthrough therapies for rare diseases, is seeking a dynamic and experienced Clinical Project Manager (CPM) to lead and manage early-phase...

  • Clinical Project Manager

    2 weeks ago

    Boston, United States Albion Rye Associates Full time

    Job Title: Clinical Project ManagerLocation: Boston, MACompany: Rare Disease BiotechEmployment Type: Full-timePosition Summary:Our client are an innovative biotech company focused on developing breakthrough therapies for rare diseases, is seeking a dynamic and experienced Clinical Project Manager (CPM) to lead and manage early-phase clinical trials. This...

  • Clinical Project Manager

    2 weeks ago

    Boston, United States Albion Rye Associates Full time

    Job Title: Clinical Project ManagerLocation: Boston, MACompany: Rare Disease BiotechEmployment Type: Full-timePosition Summary:Our client are an innovative biotech company focused on developing breakthrough therapies for rare diseases, is seeking a dynamic and experienced Clinical Project Manager (CPM) to lead and manage early-phase clinical trials. This...

  • Clinical Project Manager

    2 months ago

    Boston, United States Inozyme Pharma Full time

    Position Overview: 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...

  • Associate Project Manager

    4 weeks ago

    Boston, United States Bicara Therapeutics Full time

    Associate Project Manager / Project Manager, Clinical Operations Role OverviewBicara Therapeutics is seeking an Associate Project Manager / Project Manager to provide project management expertise and strong operational support and leadership to the team. The role is highly cross-functional with key interactions with internal and external stakeholders. In...

  • Director, Clinical Project Management

    4 months ago

    Boston, United States OM1, Inc. Full time

    OM1 is on a mission to improve health outcomes by unlocking the power of data. We are a healthcare data and technology company focused on real world clinical data and outcomes, accelerating medical research and personalizing healthcare. Our interdisciplinary team uses expertise in medicine, software, Big Data, machine learning, public health and mathematics...

  • Clinical Research Program Project Manager

    4 weeks ago

    Boston, United States Mass General Brigham Full time

    Clinical Research Program Project Manager-(3302870) Description This is an exciting opportunity for an experienced candidate who is interested in program management for a portfolio of projects focused on nutrition security, cardiometabolic disease prevention, and health equity. The Program Manager is a full-time position within the Division of General...

  • Clinical Research Program Project Manager

    2 weeks ago

    Boston, Massachusetts, United States Mass General Brigham Full time

    Job SummaryWe are seeking a highly skilled and experienced Program Manager to join our team at Mass General Brigham. The successful candidate will be responsible for the strategic management and execution of a portfolio of projects focused on nutrition security, cardiometabolic disease prevention, and health equity.Key ResponsibilitiesDevelop and implement...

  • Clinical Research Project Manager

    4 weeks ago

    Boston, Massachusetts, United States Joulé Full time

    Position: Clinical Research Project ManagerLocation: Boston, MA.Employment Type: Contract-to-HireWork Schedule: Monday to Friday; 8:30 AM - 5:00 PMCompany OverviewJoulé is a prestigious healthcare organization recognized for its excellence in managing complex medical cases across various specialties, including oncology, cardiology, and vascular health.Key...

  • Clinical Research Project Manager

    4 weeks ago

    Boston, Massachusetts, United States Mass General Brigham Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT: The Clinical Research Coordinator will play a crucial role in various research initiatives focused on the health-related challenges faced by refugees and asylum-seekers, particularly those experiencing cognitive impairments, traumatic brain injuries, and associated psychiatric conditions. This position also addresses...