Current jobs related to Clinical Trial Manager - Boston - Imbria Pharmaceuticals

  • Clinical Trials Manager

    1 week ago

    Boston, Massachusetts, United States Mass General Brigham Full time

    GENERAL SUMMARY/OVERVIEW STATEMENT: The Brain Modulation Lab within the Department of Neurosurgery at Mass General Brigham is in search of a dedicated and detail-oriented Clinical Trials Manager. This role is essential for overseeing clinical studies and research initiatives. The successful candidate will handle all aspects of data and sample acquisition for...

  • Clinical Trial Manager

    1 month ago

    Boston, United States Inozyme Pharma Full time

    We are seeking a highly motivated individual to join our team as a Clinical Trial Manager (CTM) to maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). The individual is an integral member of the study team who will facilitate operational...

  • Clinical Trial Manager

    1 month ago

    Boston, Massachusetts, United States Inozyme Pharma Full time

    We are seeking a highly motivated individual to join our team as a Clinical Trial Manager (CTM) to maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). The individual is an integral member of the study team who will facilitate operational...

  • Clinical Trial Manager

    3 weeks ago

    Boston, United States Inozyme Pharma Full time

    Position Overview: We are seeking a highly motivated individual to join our team as a Clinical Trial Manager (CTM) to maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). The individual is an integral member of the study team who will facilitate...

  • Clinical Trial Manager

    3 weeks ago

    Boston, Massachusetts, United States Inozyme Pharma Full time

    Position Overview:We are seeking a highly motivated individual to join our team as a Clinical Trial Manager (CTM) to maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). The individual is an integral member of the study team who will facilitate...

  • Clinical Trials Manager

    24 hours ago

    Boston, Massachusetts, United States Noema Pharma Full time

    About the RoleNoema Pharma is a clinical-stage biotechnology company focused on developing novel therapies for debilitating central nervous system (CNS) disorders.We are seeking a highly experienced Senior Manager to lead our Clinical Trials Team, driving cross-functional interfaces and providing direction and guidance for successful trial execution.Key...

  • Senior Manager

    21 hours ago

    Boston, Massachusetts, United States Noema Pharma Full time

    About the RoleNoema Pharma is a clinical-stage biotechnology company focused on developing novel therapies for debilitating central nervous system (CNS) disorders.We are seeking a highly experienced Senior Manager to lead our Clinical Trials Team in the execution of global clinical trials in neuroscience.Key ResponsibilitiesLead Clinical Trials Planning and...

  • Sr. Clinical Trial Manager

    2 months ago

    Boston, United States RBW Consulting Full time

    Job Title: Senior Clinical Trial ManagerLocation: Boston, MAOur client are a dynamic and innovative biotechnology company at the forefront of cellular therapy. Our mission is to develop cutting-edge treatments that improve patients' lives. Based in the vibrant biotech hub of Boston, we are a small but growing team dedicated to pioneering new therapies and...

  • Sr. Clinical Trial Manager

    3 months ago

    Boston, United States RBW Consulting Full time

    Job Title: Senior Clinical Trial ManagerLocation: Boston, MAOur client are a dynamic and innovative biotechnology company at the forefront of cellular therapy. Our mission is to develop cutting-edge treatments that improve patients' lives. Based in the vibrant biotech hub of Boston, we are a small but growing team dedicated to pioneering new therapies and...

  • Clinical Trial Associate

    3 weeks ago

    Boston, United States Bicara Therapeutics Full time

    About Bicara Therapeutics: Bicara Therapeutics is a biopharmaceutical company focused on developing innovative therapies to address unmet medical needs. Our mission is to bring groundbreaking treatments to patients with serious conditions by leveraging cutting-edge science and fostering a collaborative, dynamic work environment.Job Summary: The Clinical...

  • Clinical Trial Associate

    3 weeks ago

    Boston, United States Bicara Therapeutics Full time

    About Bicara Therapeutics: Bicara Therapeutics is a biopharmaceutical company focused on developing innovative therapies to address unmet medical needs. Our mission is to bring groundbreaking treatments to patients with serious conditions by leveraging cutting-edge science and fostering a collaborative, dynamic work environment.Job Summary: The Clinical...

  • Sr./Clinical Trial Manager

    3 weeks ago

    Boston, Massachusetts, United States Actalent Full time

    Job Title: Clinical Trial Manager Job Description We are seeking a seasoned Clinical Trial Manager with 4-7 years of experience in clinical trial management at a CRO or Pharma/biotech company. Candidates with experience in small companies and oncology are highly preferred. The role involves managing and overseeing multiple CROs and ensuring good clinical...

  • Sr./Clinical Trial Manager

    3 weeks ago

    Boston, United States Actalent Full time

    Job Title: Clinical Trial Manager Job Description We are seeking a seasoned Clinical Trial Manager with 4-7 years of experience in clinical trial management at a CRO or Pharma/biotech company. Candidates with experience in small companies and oncology are highly preferred. The role involves managing and overseeing multiple CROs and ensuring good clinical...

  • Senior Clinical Trial Manager

    2 weeks ago

    Boston, United States Bicara Therapeutics Full time

    Role OverviewThe Senior Clinical Trial Manager works within the clinical trial team to provide regional trial oversight and ensures deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Director, Clinical Operations. This role may work collaboratively on one trial...

  • Senior Clinical Trial Manager

    2 months ago

    Boston, United States ARTO Full time

    (Candidate must be located in Massachusetts)ARTO is currently working with a leading oncology biotech company dedicated to developing innovative therapies to combat cancer. With significant funding and a robust pipeline of promising drug candidates, we are at the forefront of cancer research and treatment. Our mission is to improve the lives of patients...

  • Senior Clinical Trial Manager

    2 months ago

    Boston, United States ARTO Full time

    (Candidate must be located in Massachusetts)ARTO is currently working with a leading oncology biotech company dedicated to developing innovative therapies to combat cancer. With significant funding and a robust pipeline of promising drug candidates, we are at the forefront of cancer research and treatment. Our mission is to improve the lives of patients...

  • Clinical Trial Associate

    1 month ago

    Boston, United States Pharmaceutical Research Associates, Inc Full time

    Overview As a Clinical Trial Associate, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities What you will be doing: Assist the Clinical Operations Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) in the day–to–day operational activities of assigned trials...

  • Clinical Trial Manager

    2 months ago

    Boston, United States Cpl Full time

    Manager, Trial Operations (or Senior Manager)Must live in one of these locations: - NJ, NY, DE, CA, MA, FL, D.C, DE, OR, CO8 years of experience as a CTM is required.If you do not meet these requirements, you will be instantly rejected. The successful candidate will work hands-on on several trials acting as a study lead and a manager. The successful...

  • Project Manager

    3 weeks 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...

  • Project Manager

    1 month 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 Trial Manager

3 months ago

Boston, United States Imbria Pharmaceuticals Full time

Company Overview

Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to symptoms and functional deficits. Our lead investigational product candidate, ninerafaxstat, has completed Phase 2 clinical trials in non-obstructive hypertrophic cardiomyopathy (nHCM), stable angina, and in patients at high risk of developing cardiometabolic heart failure with preserved ejection fraction (pre-HFpEF). In Phase 1 and 2 clinical trials, ninerafaxstat was shown to be well tolerated. Part 2 of our Phase 2 trial, IMPROVE-DiCE, in patients with cardiometabolic HFpEF, is ongoing with topline results expected in early 2025. For additional information, please visit .


Position Overview

This position manages overall clinical study operations including CRO and vendor management, development of project plans, budget, and resource management. They will lead the development of study operational plans and provide input into other functional area plans and processes as needed. They will provide oversight of the CRO, vendors and sites as well as ensure compliance with GCP and regulatory guidelines. Note: This position requires the incumbent to reside in the Boston area.


Responsibilities

  • Performs job with minimal supervision
  • Management of day-to-day operations of assigned clinical trial(s), leading CRO and vendor teams to ensure completion per established project team goals and in compliance with applicable GCP/ICH guidelines and other regulatory requirements
  • Acts as the clinical operations representative in a variety of cross-functional teams
  • Collaborates with the program Clinical Operations Lead to develop and manage study level timelines and budgets in accordance with corporate, department, and project goals, working closely with internal leadership and CROs
  • Management of overall project budget, participating in regular meetings with Finance team
  • Independently manage clinical study vendors tracking quality of deliverables, progress against internal goals, regularly reviewing performance metrics and other Key Performance Indicators
  • Collaborate with CRO to identify and develop training needs for site staff, CRAs, and vendors specific to the study protocol and processes, including presenting these at Investigator Meetings and Kick-off meetings
  • Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments and CRO, as applicable
  • Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
  • Responsible for management and/or oversight of eTMF structure, plans and quality, ensuring inspection readiness and serving as primary study management point-of-contact in the event of audit or inspection
  • Manage study activities including, but not limited to, investigator selection, study start-up, subject recruitment & retention, data collection, development of study plans, and database locks, study drug accountability and study closeout.
  • Actively contribute to technical and study design discussions, providing input toward clinical trial outlines, protocols, informed consent forms, and clinical study reports.
  • Collaborate with CRO and/or vendor in build of study eSystems (IXRS, ePRO, EDC, etc.), leading User Acceptance Testing and overseeing subsequent updates through the life of the trial
  • Identify issues and risks with cross functional teams and service providers; develop and present proposed solutions and provide oversight of timely resolution in a collaborative approach.
  • Preparation of updates on study status for internal and external parties
  • Collaborate with data management (internal or CRO vendor) and CRAs to ensure data quality and compliance with data cleaning timelines
  • Leads and/or contributes to department process improvements/initiatives and SOPs
  • Provide direction and mentoring to junior team members.
  • Escalate pertinent CRA performance and site compliance issues when necessary


Qualifications

  • Bachelor’s degree required, preferably in the Life Sciences or equivalent
  • 5+ years relevant clinical research experience in the pharmaceutical industry, or a similar organization (e.g. CRO), including clinical trial leadership experience, Ph3 and global experience strongly preferred
  • Prior leadership experience in study start-up
  • Global Clinical Trial experience in Phase 2 and/or Phase 3
  • Inspection readiness and inspection experience is a plus
  • Exceptional attention to detail and organizational skills
  • Excellent communication (oral and written), analytical, and project management skills
  • Ability to develop and maintain strong, collaborative relationships with key internal and external stakeholders
  • Proven ability to work independently and prioritize tasks effectively in a fast-paced, remote working environment
  • Financial budgeting and forecasting skills
  • In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
  • Must have established experience and fluency in the Microsoft Office package of programs (Excel, Word, Outlook, PowerPoint, SharePoint)


This position requires the incumbent to reside in the Boston area. We offer a competitive total compensation package and invite you to consider a career with Imbria