Current jobs related to Clinical Trials Operations Lead - Waltham, Massachusetts - Visterra

  • Clinical Trials Operations Manager

    3 days ago

    Waltham, Massachusetts, United States Clinical Dynamix Full time

    The Clinical Trials Manager role at Clinical Dynamix is a critical position that requires exceptional leadership and management skills. The successful candidate will be responsible for leading the execution of clinical studies on schedule and on budget, ensuring that they are completed to the highest standards of quality and compliance.This role involves...

  • Clinical Trials Manager

    7 days ago

    Waltham, Massachusetts, United States Clinical Dynamix Full time

    Clinical Trials ManagerThe Clinical Trials Manager is responsible for leading the execution of clinical studies on schedule and on budget. This role requires a high level of experience, skill, and capacity to manage larger and/or more complex studies, projects, or programs.Accountable for project-related efforts for the delivery of studies or programs that...

  • Senior Clinical Trial Manager

    7 days ago

    Waltham, Massachusetts, United States Clinical Dynamix Full time

    Job SummaryWe are seeking a highly experienced Senior Clinical Trial Manager to lead the execution of clinical studies on schedule and on budget. The successful candidate will be responsible for ensuring studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with the company's strategic goals.Key...

  • Clinical Trial Operations Manager

    2 weeks ago

    Waltham, Massachusetts, United States Precision Life Sciences Full time

    Job SummaryWe are seeking a highly skilled Clinical Trial Operations Manager to join our team at Precision Life Sciences. The successful candidate will be responsible for driving the operational planning, content, execution, and delivery for one or more clinical trials.Key ResponsibilitiesDevelop and implement operational plans for clinical trials, ensuring...

  • Clinical Trial Associate

    4 weeks ago

    Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Trial Associate to support our Clinical Operations team in the management of clinical trials. The ideal candidate will have a strong understanding of clinical trial operations and be able to work effectively in a fast-paced environment.Key ResponsibilitiesSchedule and coordinate...

  • Clinical Trial Operations Professional

    3 days ago

    Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time

    About the RoleWe are seeking a highly skilled Clinical Trial Associate to join our team at Beacon Hill Life Sciences in Boston. This is a fantastic opportunity to work in a dynamic and growing company environment where you will be responsible for assisting with daily clinical trial execution activities, including the coordination of documents associated with...

  • Clinical Trial Associate

    3 weeks ago

    Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Trial Associate to support our Clinical Operations team in the management of clinical trials.Key Responsibilities:Coordinate trial-related activities, including scheduling and preparing materials for meetings.Take and distribute accurate meeting minutes, both internal and...

  • Clinical Trial Manager

    2 weeks ago

    Waltham, Massachusetts, United States Alkermes Full time

    Job Title: Clinical Trial ManagerAlkermes is seeking a highly skilled Clinical Trial Manager to join our team. As a Clinical Trial Manager, you will be responsible for overseeing the execution of clinical trials in support of our clinical programs.Key Responsibilities:Lead clinical project teams to ensure timely and successful completion of clinical...

  • Clinical Trial Manager

    2 weeks ago

    Waltham, Massachusetts, United States Alkermes Full time

    Job DescriptionAlkermes is seeking a highly skilled Clinical Trial Manager to join our team. As a Clinical Trial Manager, you will be responsible for overseeing the execution of clinical trials in support of clinical programs in Phases I-IV of development.Key Responsibilities:Lead and manage clinical trial teams to ensure timely and successful completion of...

  • Clinical Trial Associate

    1 week ago

    Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time

    Job OverviewThe Clinical Trial Associate will support our Clinical Operations team in the management of clinical trials, including planning, execution, and closeout. This role is ideal for individuals with a strong background in clinical research and a passion for working in a fast-paced environment.Key Responsibilities:Scheduling activities and meetings,...

  • Clinical Trial Manager

    4 weeks ago

    Waltham, Massachusetts, United States CK Group Full time

    CK Group is seeking a highly motivated and experienced Clinical Trial Manager to join a clinical stage precision immuno-oncology company on a contract role in the US. This person will be responsible for the successful planning, implementation, and execution of contracted clinical monitoring activities. They will ensure clear client and internal team...

  • Clinical Trial Associate

    4 days ago

    Waltham, Massachusetts, United States Beacon Hill Full time

    Clinical Trial Associate Job SummaryWe are seeking a highly organized and detail-oriented Clinical Trial Associate to join our team at Beacon Hill. As a Clinical Trial Associate, you will play a critical role in the execution of clinical trials, working closely with our Clinical Trial Managers to ensure the successful coordination of documents and activities...

  • Clinical Trials Manager

    2 weeks ago

    Waltham, Massachusetts, United States Royalty Staffing Full time

    Clinical Trials Manager Job DescriptionThe Clinical Trials Manager is a critical role within our organization, responsible for leading the execution of clinical studies on schedule and on budget. This position requires a high level of expertise, skill, and capacity to manage larger and/or more complex studies, projects, or programs.Key...

  • Associate Director, Clinical Business Operations Lead

    3 weeks ago

    Waltham, Massachusetts, United States BioSpace, Inc. Full time

    Job Title: Associate Director, Clinical Business OperationsJob Summary:The Associate Director, Clinical Business Operations will provide strategic leadership and oversight for clinical trial financial management, vendor outsourcing, and budget management. This role will work closely with cross-functional teams to ensure efficient and cost-effective execution...

  • Associate Director, Clinical Business Operations Lead

    3 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Inc Full time

    Job Title: Associate Director, Clinical Business OperationsCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are...

  • Clinical Trials Manager

    1 week ago

    Waltham, Massachusetts, United States Alkermes Full time

    Job SummaryAlkermes is seeking a highly skilled Clinical Trials Manager to oversee the execution of clinical trials in support of clinical programs in Phases I-IV of development. The successful candidate will work closely with the Clinical Program Manager and be responsible for oversight, planning, and execution of assigned clinical studies, timelines, and...

  • Clinical Operations Director

    2 weeks ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job Title: Director, Clinical Operational ExcellenceDeciphera Pharmaceuticals is seeking a highly skilled and experienced Director, Clinical Operational Excellence to lead our clinical operations team. As a key member of our organization, you will be responsible for driving the operational performance and quality of all clinical trials sponsored by...

  • Clinical Operations Director

    1 week ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job DescriptionDeciphera Pharmaceuticals is seeking a highly skilled Clinical Operations Director to lead our Center of Excellence in improving the operational performance and quality of all clinical trials sponsored by our company.The ideal candidate will have a strong background in clinical development, global regulatory requirements, and CRO/vendor...

  • Clinical Trial Associate

    1 week ago

    Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time

    Job DescriptionBeacon Hill Life Sciences - Boston is seeking a highly skilled Clinical Trial Associate to join our team. As a Clinical Trial Associate, you will play a critical role in the execution of clinical trials, working closely with our Clinical Trial Managers to ensure the successful conduct of studies.Key Responsibilities:Organize and maintain...

  • Clinical Trial Associate

    2 weeks ago

    Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time

    Job SummaryThe Clinical Trial Associate will support the Clinical Operations team in the management of clinical trials, including planning, execution, and closeout. This role will involve scheduling activities, taking and distributing meeting minutes, and reviewing files within the Trial Master File.Key Responsibilities:Scheduling and coordinating meetings...

Clinical Trials Operations Lead

2 months ago

Waltham, Massachusetts, United States Visterra Full time
Job Overview

Position Title: Clinical Trial Manager

Salary: Competitive

Position Summary:

Visterra is in search of a Clinical Trial Manager (CTM) who will play a pivotal role within our Clinical Operations division. The CTM is instrumental in overseeing the execution and administration of clinical trials, reporting directly to the Associate Director of Clinical Operations. The ideal candidate will possess a B.S. degree in a scientific or healthcare discipline, along with a minimum of five years of experience in research.

Key Responsibilities:

  • Directs tasks assigned by management with confidence and sound judgment.
  • Oversees CROs and other vendors to ensure timely and budget-compliant task completion.
  • Collaborates closely with the internal cross-functional study execution team to ensure the seamless execution of early-phase clinical trials.
  • Identifies potential risks and escalates issues to management with proposed mitigation strategies.
  • Manages the document finalization process with both internal and external stakeholders, ensuring all feedback is addressed.
  • Assists in the creation and development of clinical study documents, including Informed Consent Forms (ICF), study protocols, and pharmacy manuals.
  • Ensures timely management and completion of all clinical data. Monitors vendor systems, develops tracking tools, and prepares reports for the study team. Responsible for the preparation and oversight of the Trial Master File (TMF) and internal documentation, including periodic reviews as per the TMF plan.
  • May engage in regulatory audits and inspections as necessary.
  • Facilitates internal study meetings, including the preparation of agendas, presentations, and meeting minutes.

Qualifications:

  • Bachelor’s degree in science, healthcare, or a related field is required.
  • Minimum of 5 years of clinical research experience in a pharmaceutical, biotech, or CRO setting, with at least two years in clinical study management.
  • Strong understanding of GCP/ICH Guidelines and relevant CFRs for conducting clinical trials.
  • Excellent communication skills (both written and verbal), adaptability, and self-motivation.
  • Ability to manage shifting priorities effectively.
  • Strong interpersonal, organizational, and multitasking abilities.
  • Exceptional attention to detail and problem-solving capabilities.
  • Proficient in working both remotely and in-person.
  • Computer skills, including proficiency in Microsoft Office applications, and experience with EDC, TMF, and CTMS systems.
  • Willingness to travel, typically less than 15% of the time.

About Visterra:

Visterra is a clinical-stage biotechnology firm dedicated to developing innovative antibody-based therapies aimed at treating kidney diseases and other challenging conditions. Our proprietary technology platform allows for the design and engineering of precision antibody-based product candidates that specifically target and modulate key disease markers. By applying this technology to disease targets inadequately addressed by conventional therapeutic methods, we are building a robust pipeline of novel therapies for patients with unmet medical needs.

As a wholly-owned subsidiary of Otsuka America, Inc., Visterra is part of a larger organization committed to advancing healthcare solutions. Our team is comprised of approximately 115 professionals dedicated to our mission.

Visterra is an equal opportunity employer, committed to fostering a diverse and inclusive workplace.