Beth Israel Deaconess Medical CenterBoston
Works with interdisciplinary leadership in assigned clinical service areas to define and oversee best practice standards. Demonstrates advanced clinical knowledge and the ability to provide supervision and consultation in complex psychosocial, ethical, and risk management situations.
Oversees develo...
Katalyst Healthcares & Life SciencesWaltham (MA)
Good working knowledge of regulatory guidelines such as GCP, 21 CFR Part 11, etc.
Solid understanding of clinical research methods, Clinical Data Interchange Standards Consortium (CDISC) principles, best data management practices and technologies...
MindlanceCambridge, 6 mi from Waltham (MA)
Job Description: Repost: 30584
POSITION SUMMARY
We are looking for a self-directed professional to support clinical data management efforts for the Biomeasures Endpoints and Study Technologies (BEST) projects and the Client Innovation Research...
AL SolutionsCambridge, 6 mi from Waltham (MA)
Bachelor’s degree in a related field & 5 years of relevant experience required; at least 3 years experience in clinical data management in a clinical research setting also required.
2 years of experience in leading project teams required.
Certifications...
AKIMABoston
The Program Manager leads project workstreams for a complex Air Force Enterprise IT modernization effort that delivers Software-Defined Wide Area Network (SD-WAN) and Secure Access Service Edge (SASE) solutions. Act as the single point of contact for all SD-WAN and SASE Original Manufacturers (OEMs)...
Booz Allen HamiltonLexington
Technical Program Manager, Lead. Design, implement, and maintain strategic, multi-disciplinary IT programs in support of corporate strategy. Knowledge of establishing and documenting repeatable programmatic and te. Our offerings include health, life, disability, financial, and retirement benefits, a...
Abacus Technology CorporationHanscom Air Force Base
Knowledge of support activities that assist the program manager in assessing what programs are within schedule and cost baselines, be able to recommend viable solutions to problems, and the pursuit of alternative courses of action. Abacus Technology is seeking a Program Manager to provide acquisitio...
Dana-Farber Cancer InstituteBoston, 10 mi from Waltham (MA)
The Research Nurse in collaboration with the physician, is responsible for the implementation and evaluation of clinical research in their specific program/area. The CRN has expert knowledge of cancer as a disease process, cancer treatment...
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Senior Clinical Trials Manager
Clinical Dynamix, Inc. | Waltham | www.jobvertise.com |
Global Publicly Traded Pharmaceutical company is expanding.
The Senior Clinical Trials Manager / Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. Senior CTM / CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.
Candidates should be located in MA as office is in Waltham and will require on-site presence from time to time.
Responsibilities
• Accountable for project related efforts for the delivery of studies or programs that are critical to a products clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
• Supports external vendor selection and management process and assists in the development of RFPs and vendor oversight plans.
• Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.
• Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.
• Project leadership of the cross-functional study team, including external team members, CROs and vendors.
• Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
• Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones.
• May provide technical advice to team members.
• Disseminate clinical program communications to all functional groups and leads program, study and team meetings.
• Interact with clinical research investigators, Key Opinion Leaders and sites.
• Interact with Senior Management to report on progress of milestones.
• Oversight of study team and site training
• Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
• Management of study drug distribution and accountability processes and documentation
• Oversight of study start-up, study management, data cleaning, and study closeout activities
• Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival
• Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.
Requirements
• BA/BS degree in Health or Life Sciences required, advanced degree preferred
• A minimum 5+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
• Exceptional communication and interpersonal skills
• Positive team orientated attitude
• Must speak fluent English if it is their second language
• Advanced proficiency in Microsoft Office and Microsoft Project
• Reliable, self-motivated, team player
• Detail oriented with excellent organizational skills
• Ability to effectively manage multiple tasks and competing priorities
• Creative problem solver
• Ability to travel is required
Company offers a flexible work environment. This position is a hybrid work model based out of our Waltham, MA office.
Company offers a comprehensive benefits package including:
Remote work with technology tools and infrastructure
Competitive pay and stock options for all employees
The Senior Clinical Trials Manager / Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. Senior CTM / CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.
Candidates should be located in MA as office is in Waltham and will require on-site presence from time to time.
Responsibilities
• Accountable for project related efforts for the delivery of studies or programs that are critical to a products clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
• Supports external vendor selection and management process and assists in the development of RFPs and vendor oversight plans.
• Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.
• Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.
• Project leadership of the cross-functional study team, including external team members, CROs and vendors.
• Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
• Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones.
• May provide technical advice to team members.
• Disseminate clinical program communications to all functional groups and leads program, study and team meetings.
• Interact with clinical research investigators, Key Opinion Leaders and sites.
• Interact with Senior Management to report on progress of milestones.
• Oversight of study team and site training
• Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
• Management of study drug distribution and accountability processes and documentation
• Oversight of study start-up, study management, data cleaning, and study closeout activities
• Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival
• Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.
Requirements
• BA/BS degree in Health or Life Sciences required, advanced degree preferred
• A minimum 5+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
• Exceptional communication and interpersonal skills
• Positive team orientated attitude
• Must speak fluent English if it is their second language
• Advanced proficiency in Microsoft Office and Microsoft Project
• Reliable, self-motivated, team player
• Detail oriented with excellent organizational skills
• Ability to effectively manage multiple tasks and competing priorities
• Creative problem solver
• Ability to travel is required
Company offers a flexible work environment. This position is a hybrid work model based out of our Waltham, MA office.
Company offers a comprehensive benefits package including:
Remote work with technology tools and infrastructure
Competitive pay and stock options for all employees
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