Clinical Trial Associate
1 week ago
Beacon 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 tracking systems to support the conduct of clinical studies from start-up to close-out.
- Assist with the development and review of clinical documents, including protocols, ICFs, and clinical study plans.
- Schedule and coordinate study meetings, materials, and agendas, recording and disseminating decisions and actions.
- Coordinate and manage version control of clinical documents, prioritize multiple tasks and/or projects with limited supervision.
- Facilitate vendor engagement from RFP distribution through to final contracting and PO setup.
- Setup and organize Sharepoint and central study files.
- Coordinate training for assigned clinical studies.
- Manage study laboratory sample tracking and vendor management support.
- Assist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages.
- Support Clinical Operations team with specific projects.
- Effectively communicate with study team members and work closely to address challenges.
Requirements:
- BS/BA degree or equivalent and at least one year of experience in clinical operations in a Sponsor company with 1+ years strongly preferred.
- Knowledge of drug development, clinical operation processes, and documentation, including study start-up procedures, maintenance phase, and study close-out procedures.
- Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations.
- Experience with eTMF; ability to directly apply essential document knowledge to file documents.
- Effective communication, organizational, and interpersonal/team skills.
- Proficient in MS Excel, Word, and PowerPoint. Knowledge of MS Project and SharePoint preferred.
- Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines.
- Participate in inter-departmental workgroups to create or enhance processes.
- Strong attention to quality/detail.
- Good organizational and time management skills.
- Willingness to work in a flexible environment.
Preferred Qualifications:
- Experience with global studies, using an outsourced CRO model.
- Experience in clinical drug development with knowledge of First in Human trials.
- Experience with regulatory affairs, including IND/CTA submissions.
- Experience working on dermatology.
-
Clinical Trials Operations Manager
4 days ago
Waltham, Massachusetts, United States Clinical Dynamix Full timeThe 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
1 week ago
Waltham, Massachusetts, United States Clinical Dynamix Full timeClinical 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 Trial Associate
4 weeks ago
Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full timeJob 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 Associate
3 weeks ago
Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full timeJob 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 Associate
1 week ago
Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full timeJob 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,...
-
Senior Clinical Trial Manager
1 week ago
Waltham, Massachusetts, United States Clinical Dynamix Full timeJob 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 Associate
5 days ago
Waltham, Massachusetts, United States Beacon Hill Full timeClinical 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 Associate
2 weeks ago
Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full timeJob 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 Trial Associate
2 weeks ago
Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full timeJob 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
4 weeks ago
Waltham, Massachusetts, United States CK Group Full timeCK 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 Manager
2 weeks ago
Waltham, Massachusetts, United States Alkermes Full timeJob 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 timeJob 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 Operations Professional
3 days ago
Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full timeAbout 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 Operations Manager
2 weeks ago
Waltham, Massachusetts, United States Precision Life Sciences Full timeJob 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 Trials Manager
2 weeks ago
Waltham, Massachusetts, United States Royalty Staffing Full timeClinical 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 Trials Manager
1 week ago
Waltham, Massachusetts, United States Alkermes Full timeJob 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 Research Associate
4 weeks ago
Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full timeJob Title: Clinical Trial AssociateWe 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:Schedule and coordinate activities and meetings, including preparation of materials and presentations.Take and distribute meeting minutes, ensuring...
-
Clinical Research Associate
4 weeks ago
Waltham, Massachusetts, United States BostonGene Full timeJob Summary:BostonGene is seeking a highly skilled Clinical Research Associate to support the clinical laboratory's daily operations, ensuring quality control, and contributing to various research projects. This role involves performing clinical immunohistochemistry (IHC), optimizing IHC and immunofluorescence (IF) methods, maintaining laboratory equipment,...
-
Clinical Trial Manager, Site Start-up
2 weeks ago
Waltham, Massachusetts, United States Viridian Therapeutics Full timeJob SummaryAs a Clinical Trial Manager, Site Start-up at Viridian Therapeutics, you will play a critical role in leading the start-up process for clinical trials. Reporting to the Director/Senior Director of Clinical Operations, you will be responsible for overseeing the end-to-end start-up, site initiation, and site activation process for multiple complex...
-
Waltham, Massachusetts, United States Dyne Therapeutics Inc Full timeJob 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...