Current jobs related to Clinical Project Manager - Waltham - Dyne Therapeutics

  • Clinical Trials Manager

    6 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...

  • Clinical Trials Operations Manager

    2 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...

  • Senior Clinical Trial Manager

    6 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...

  • Senior Clinical Project Manager

    2 weeks ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job Title: Senior Clinical Project ManagerDeciphera Pharmaceuticals is seeking a highly skilled Senior Clinical Project Manager to lead the successful execution of clinical trials from protocol conception through the clinical study report. The ideal candidate will have a strong background in clinical trial management, excellent communication and...

  • Clinical Trials Manager

    1 week 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 Manager

    4 months ago

    Waltham, United States Royalty Staffing Full time $130,000 - $155,000

    The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid in-office...

  • 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 Trials Manager

    6 days 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 Research Associate

    4 weeks ago

    Waltham, Massachusetts, United States BostonGene Full time

    Job 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,...

  • Regulatory Affairs Project Manager

    3 days ago

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

    Job Title: Regulatory Affairs Project ManagerThe Regulatory Affairs Project Manager is a key member of the Global Regulatory Affairs team at BioSpace, Inc. This role is responsible for facilitating timely submission of high-quality data packages to US and international health authorities. The successful candidate will work closely with cross-functional teams...

  • IT Project Manager

    7 days ago

    Waltham, Massachusetts, United States Corrona Full time

    Project Manager Job DescriptionAs the leader of project teams, the Project Manager will oversee a wide range of projects with a primary focus on IT-related projects including the implementation of a new data warehouse.This program is complex and will involve some challenging joint project team management.The successful candidate should be adept at developing...

  • Project Manager

    1 week ago

    waltham, United States Global Partners LP Full time

    Global Partners is currently seeking a dynamic and experienced Project Manager to join our Enterprise Project Management Office in our headquarters location. We are looking for a creative and dedicated individual, who is open-minded, business and operationally oriented, with demonstrated project management skills who will fit with our collaborative culture....

  • Project Manager

    3 weeks ago

    Waltham, United States Global Partners LP Full time

    Global Partners is currently seeking a dynamic and experienced Project Manager to join our Enterprise Project Management Office in our headquarters location. We are looking for a creative and dedicated individual, who is open-minded, business and operationally oriented, with demonstrated project management skills who will fit with our collaborative culture....

  • Project Manager

    3 weeks ago

    Waltham, United States Global Partners LP Full time

    Global Partners is currently seeking a dynamic and experienced Project Manager to join our Enterprise Project Management Office in our headquarters location. We are looking for a creative and dedicated individual, who is open-minded, business and operationally oriented, with demonstrated project management skills who will fit with our collaborative culture....

  • Project Manager

    3 weeks ago

    Waltham, United States Global Partners LP Full time

    Global Partners is currently seeking a dynamic and experienced Project Manager to join our Enterprise Project Management Office in our headquarters location. We are looking for a creative and dedicated individual, who is open-minded, business and operationally oriented, with demonstrated project management skills who will fit with our collaborative culture....

  • Project Manager

    4 weeks ago

    Waltham, Massachusetts, United States TG Gallagher Full time

    About the RoleWe are seeking a highly motivated and experienced Project Manager to join our team at TG Gallagher. As a Project Manager, you will be responsible for overseeing the successful delivery of construction projects from start to finish, ensuring that they are completed on time, within budget, and to the highest quality standards.Key...

  • Clinical Data Management Director

    3 weeks ago

    Waltham, Massachusetts, United States Management Business Solutions Full time

    Associate Director, Clinical Data ManagementManagement Business Solutions is seeking an experienced Associate Director, Clinical Data Management to lead the clinical data management strategy for the organization.The ideal candidate will have a strong background in clinical data management, with experience in overseeing the start-up and execution of multiple,...

  • Project Manager

    1 week ago

    Waltham, Massachusetts, United States Delphi Construction Full time

    h3Job Description/h3pDelphi Construction, Inc. is seeking a skilled bProject Manager/b to oversee and coordinate various construction projects from start to finish. The ideal candidate will have a strong background in construction management and excellent communication skills./ppbKey Responsibilities:/b/pulliDevelop and maintain good working relationships...

  • 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...

  • Project Manager

    2 days ago

    Waltham, Massachusetts, United States RailWorks Full time

    Job Title: Project EngineerJob Summary:RailWorks is seeking a highly skilled Project Engineer to join our team. As a Project Engineer, you will be responsible for planning, developing, managing, and coordinating engineering activities for construction projects.Key Responsibilities:Manage project engineering activities to ensure compliance with company and...

Clinical Project Manager

3 months ago

Waltham, United States Dyne Therapeutics Full time
Company 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 FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).

Role Summary:

The Clinical Project Manager ensures that clinical strategies related to unblinded oversight of the trials are translated into operational plans and executed in line with clinical development plans (CDPs). This position is responsible for initiating and leading the unblinded aspect of clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives with agreed upon project priorities, timing, budget, and quality requirements. This position ensures the study blind is maintained and study conduct adheres to all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Dyne’s policies and SOPs. This individual will be responsible for managing unblinded operations for multiple clinical studies of varying complexity. This role is expected to require up to 20% travel, including international travel.

This role is based in Waltham, MA without the possibility of being a fully remote role. Primary Responsibilities Include:

Manage, independently or in partnership with other unblinded team members, all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance applicable SOPs, guidelines and regulations Work closely with Dyne Supply, CMC and Quality Departments to ensure drug product and ancillary supplies/materials are shipped, properly stored and maintained and re-supplied as needed at sites to ensure on time treatment of patients Track site supply and projections for study drug usage on a per site, per patient basis in collaboration with the supply team Manage to resolution all IRT issues and site queries in partnership with CRO Act as unblinded data liaison resource for Dyne Biostatistics, Clinical Development, Data Management and other key blinded stakeholders Project manage all unblinded site issues, including but not limited to product complaints, storage capacity, pharmacy queries, and all site unblinded communications Carry out unblinded co-monitoring and site visits as deemed necessary (foreign travel expected) Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities Support the selection, oversight, and management of CROs and other vendors Monitor and assess vendor performance against contractual operational deliverables. Drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors Provide oversight of study scope, quality, timelines and budget with the internal Dyne functional leads, CRO and vendors to ensure project objectives remain on track Participate in cross-functional teams and manage study team in partnership with the CRO Participate in a site engagement activities to build solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and execution Participate in planning and conducting investigator meetings together with the CRO Evaluate issues, interpret data, and suggest and implement solutions and mitigation as required Create appropriate risk assessments and mitigation plans, perform regular reviews to continually assess changing circumstances Review and provide unblinded clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate Provide ongoing oversight, maintenance and evaluate completeness of the TMF by performing periodic QC reviews to ensures the TMF and study is always “inspection ready” Prepare high-quality reports and dashboards (financial, project, etc.) for senior management on program status and issues as required

  Education and Skills Requirements:

B.A. or B.S. in a scientific discipline; advanced degree desirable Minimum of 3-5 years of clinical trial management experience in conducting Phase I-III International clinical trials in pharma/biotech organization Experience managing Blinded studies is required Scientifically and clinically astute with very strong project management skills Previous experience working with supply, CMC, quality and site pharmacies in an unblinded capacity preferred Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, US/EU patient data privacy laws Understand clinical study budgets, accruals, and forecasting Experience with clinical studies in muscular dystrophies desirable Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously Understand technical, scientific and medical information, to plan, organize, project manage and analyze data Enjoy building relationships with KOLs and site personnel with a willingness to travel to establish and build relationships Experience in vendor selection and overseeing studies being managed by a CRO Ability to successfully engage and work collaboratively with clinical operations team members/colleagues Excellent interpersonal and decision-making skills Demonstrated innovation, possesses drive, energy and enthusiasm to deliver the program objectives Excellent planning, time management & coordination skills Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Experience in working in a small organization Ability to travel for up to 20% is required (including overnight stays) Excellent written and oral communication skills Full competency in Microsoft Office programs

#LI-Onsite

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.