- 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.
- 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
-
TScan Therapeutics Waltham, United StatesPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Operations team to support the executi ...
-
Clinical Trial Manager
5 days ago
Staffmark Group Waltham, United StatesGreat long term contract opportunity for a Clinical Trial Manager with a local pharmaceutical company in Waltham MA. Looking for 5+ years clinical research experience in a pharmaceutical/biotech, CRO setting. Strong knowledge and understanding of GCP/ICH Guidelines for conducting ...
-
Clinical Trial Manager
5 days ago
Dragonfly Therapeutics Waltham, United StatesClinical Trial Manager · Dragonfly Therapeutics seeks a Clinical Trial Manager with relevant Clinical Operations experience to join our Clinical Development group and who will be responsible for providing trial management support for our cancer immunotherapy programs. This role ...
-
Clinical Trial Manager
2 weeks ago
BioSpace Waltham, United StatesJob Details · Summary · Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team. The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s). The CTM reports to the Associate Director, Clinical Operati ...
-
Clinical Trial Manager
1 week ago
Dragonfly Therapeutics, Inc. Waltham, United StatesClinical Trial Manager · Dragonfly Therapeutics seeks a Clinical Trial Manager with relevant Clinical Operations experience to join our Clinical Development group and who will be responsible for providing trial management support for our cancer immunotherapy programs. This role ...
-
TScan Therapeutics Waltham, United StatesPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Operations team to support the execut ...
-
Viridian Therapeutics Inc. Waltham, United States· At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driv ...
-
Clinical Trial Manager
1 week ago
BioSpace, Inc. Waltham, United StatesJob Details · Summary · Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team. The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s). The CTM reports to the Associate Director, Clinical Opera ...
-
Clinical Trial Manager
3 weeks ago
Visterra, Inc. Waltham, United States Full timeSummary · Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team. The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s). The CTM reports to the Associate Director, Clinical Operations. The ideal ...
-
Clinical Trial Manager
1 week ago
Visterra Inc. Waltham, United StatesSummary · Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team. The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s). The CTM reports to the Associate Director, Clinical Operations. The ideal ...
-
Clinical Trial Manager
4 days ago
Advantage Technical Waltham, United StatesGreat long term contract opportunity for a Clinical Trial Manager with a local pharmaceutical company in Waltham MA. Looking for 5+ years clinical research experience in a pharmaceutical/biotech, CRO setting. Strong knowledge and understanding of GCP/ICH Guidelines for conducting ...
-
Clinical Trial Manager
1 week ago
Alkermes Waltham, United StatesJob Description · Position Summary: · Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I-IV of development. · Responsibilities · Clinical project team member: works closely with the Sr. CTM and/or Clinical Pro ...
-
Tscanrx Waltham, United StatesClinical Trial Manager/Senior Clinical Trial Manager (CT30-2) · LOCATION:Waltham, MA · POSITION SUMMARY: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking f ...
-
TScan Therapeutics Waltham, United StatesJob Description · Job DescriptionPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Opera ...
-
TScan Therapeutics Waltham, United StatesJob Description · Job DescriptionPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Manager to join our Clinical Operati ...
-
Clinical Trial Manager
1 week ago
Visterra Waltham, United StatesJob Description · Job DescriptionSalary: · Summary · Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team. The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s). The CTM reports to the Associ ...
-
Clinical Trial Manager
5 days ago
Alkermes Waltham, United StatesPosition Summary: Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I‐IV of development. ...
-
Clinical Trial Manager
3 weeks ago
Alkermes Watertown, United StatesJob Description · Position Summary: Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I-IV of development. · ResponsibilitiesClinical project team member: works closely with the Sr. CTM and/or Clinical Program Man ...
-
Senior Clinical Trial Manager
3 weeks ago
Planet Pharma Waltham, United StatesImmediate Need for a Senior Clinical Trial Manager in Waltham, MA with a biotech company. This is a full time permanent position. Must be able to work hybrid in Waltham, MA. · Looking for 3+ years of clinical trial management experience at a biotech or pharmaceutical company. · ...
-
Senior Clinical Trial Manager
5 days ago
BioSpace Waltham, United StatesJob Details · Summary · The Senior Clinical Trial Manager is a key member of the clinical operations team and supports the execution and management of clinical trial(s). The Senior Clinical Trial Manager reports to the Associate Director, Clinical Operations. The ideal candidate ...
Senior Clinical Trials Manager - Waltham, United States - Clinical Dynamix
Description
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
Requirements
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
