Clinical Trials Manager

4 weeks ago

Waltham, Massachusetts, United States Alkermes Full time
Job Summary

Alkermes 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 key deliverables.

Key Responsibilities
  • Lead clinical project teams and work closely with Clinical Outsourcing on selection of CROs and vendors, RFI, RFP, and bid defenses, and contract and budget negotiations.
  • Oversee and work directly with CROs, vendors, field monitors, and other partners, establishing relationships with investigators, study coordinators, site personnel, and other external key stakeholders.
  • Develop and manage study budgets and financial reporting, including month-end and quarterly flash reporting, financial reconciliation, accruals, and re-forecasting, with Clinical Outsourcing, Finance, and Project Management.
  • Responsible for study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects.
  • Work with Patient Recruitment department and be responsible for overall recruitment strategy, enrollment projections, and meeting established targets.
  • Coordinate and/or participate in development of clinical study documents, including ICF, monitoring plans, recruitment plans, and other program/study-related documents.
  • Lead and participate in internal cross-functional clinical team meetings, serving as the main point of contact for study-level status updates.
  • Presents at clinical team meetings and other forums on study progress.
  • Work with Study Start-up and coordinates study start-up activities, including feasibility, investigational product and materials preparation, trial master file setup, CRFs, regulatory documents, and site contracts in conjunction with other relevant departments.
  • Participate in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management, and field monitors.
  • Participate in SOP development, process mapping, training of junior CTMs and CTAs, and other departmental activities.
  • Direct line management and supervision of CTM/CTAs, responsible for performance reviews and supporting professional development for direct reports.
Requirements
  • Science background: BS or healthcare degree required, Masters preferred.
  • Experience: 7-10+ years clinical research experience in a pharmaceutical/biotech, CRO setting.
  • Monitoring experience, a plus.
  • Strong knowledge and understanding of GCP/ICH guidelines for conducting clinical trials.
  • Strong leadership, interpersonal, organizational, and multi-tasking skills.
  • Excellent attention to detail and problem-solving skills.
  • Ability to work effectively in a team setting.
  • Travel domestic and international - up to 25%.
About Alkermes

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients.

We actively seek to foster a culture of diversity, inclusion, and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background, and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service, or any other characteristic protected by local, state, or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

  • Clinical Trials Manager

    4 weeks 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...

  • Clinical Trials Operations Manager

    3 weeks 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...

  • Senior Clinical Trial Manager

    4 weeks 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 Trials Manager

    4 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...

  • Clinical Trial Associate

    4 weeks 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 Associate

    3 weeks 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 Trial Operations Professional

    3 weeks 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

    4 weeks 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

    4 weeks ago

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

    Job DescriptionBeacon Hill Life Sciences - Boston is seeking a highly organized and detail-oriented Clinical Trial Associate to support the execution of clinical trials. The ideal candidate will have a strong understanding of clinical operations and regulatory affairs.Key Responsibilities:Coordinate and manage clinical trial documents, including protocols,...

  • Clinical Trial Manager, Site Start-Up Specialist

    3 weeks ago

    Waltham, Massachusetts, United States Viridian Therapeutics Full time

    Job SummaryReporting to the Director/Senior Director of Clinical Operations, the Clinical Trial Manager, Site Start-up is accountable for leading, directing, and overseeing end-to-end start-up, site initiation, and site activation in collaboration with key stakeholders across multiple complex studies in a fast-paced environment.Key ResponsibilitiesProvides...

  • Clinical Trial Manager, Site Start-Up Position

    3 weeks ago

    Waltham, Massachusetts, United States Viridian Therapeutics Full time

    Job SummaryViridian Therapeutics, Inc. is seeking a highly skilled Clinical Trial Manager, Site Start-Up to lead the end-to-end start-up, site initiation, and site activation process for multiple complex studies. This role requires strong collaboration with key stakeholders, expertise in study start-up practices, and a focus on efficient start-up activities...

  • Global Oncology Clinical Development Manager

    4 weeks ago

    Waltham, Massachusetts, United States GlaxoSmithKline Full time

    Job SummaryWe are seeking a highly experienced Clinical Operations Manager to lead our Oncology clinical trials. The successful candidate will have a strong background in clinical development, with a proven track record of delivering high-quality studies on time and within budget.The ideal candidate will have excellent leadership and communication skills,...

  • Clinical Operations Director

    4 weeks 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 Business Operations Director

    3 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Inc Full time

    Job Summary:The Associate Director, Clinical Business Operations will provide support for vendor outsourcing and financial oversight for Dyne's clinical trials. This role is responsible for ensuring efficient, accurate clinical trial financial management including forecasting, reporting, and oversight of vendor spend. The Associate Director, Clinical...

  • Clinical Business Operations Director

    4 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Inc Full time

    Job Summary:The Associate Director, Clinical Business Operations provides strategic leadership and oversight for clinical trial financial management, vendor outsourcing, and budget negotiations. This role is responsible for ensuring efficient, accurate clinical trial financial management, including forecasting, reporting, and oversight of vendor spend. The...

  • Clinical Data Management Director

    3 weeks ago

    Waltham, Massachusetts, United States Upstream Bio Full time

    Position Summary:As Associate Director, Data Management, you will oversee clinical data management activities within clinical programs, ensuring quality and adherence to timelines. This role assumes a leadership position in end-to-end data acquisition planning and implementation, collaborating closely with cross-functional teams to identify and evaluate the...

  • Clinical Business Operations Director

    3 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Inc Full time

    Job SummaryWe are seeking a highly skilled and experienced Associate Director, Clinical Business Operations to join our team at Dyne Therapeutics Inc. This role will be responsible for providing support for vendor outsourcing and financial oversight for our clinical trials.Key ResponsibilitiesEnsure efficient, accurate clinical trial financial management,...

  • Clinical Business Operations Director

    4 weeks ago

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

    Job SummaryThe Associate Director, Clinical Business Operations provides strategic support for vendor outsourcing and financial oversight for Dyne's clinical trials. This role is responsible for ensuring efficient, accurate clinical trial financial management, including forecasting, reporting, and oversight of vendor spend.This role assists with contract and...

  • Clinical Research Specialist

    3 weeks ago

    Waltham, Massachusetts, United States Upstream Bio Full time

    Position Overview:We are seeking a highly motivated and detail-oriented Clinical Scientist to support our ongoing clinical trials, with a particular focus on asthma exacerbations. The Clinical Scientist will play a pivotal role in the design, execution, and management of clinical trials aimed at developing breakthrough therapies in the inflammation space.Key...

  • Senior Manager, Clinical Operations

    3 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview: At Dyne Therapeutics, we are revolutionizing the field of muscle disease treatment with our cutting-edge FORCETM platform. Our mission is to develop innovative therapeutics that transform the lives of individuals living with genetically driven diseases. With a strong focus on clinical-stage muscle disease development, we are driven to...