Senior Clinical Trial Manager
2 weeks ago
Senior Clinical Trial Manager
Description
Reporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with the company’s strategic goals. The level reflects 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 are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):
- Accountable for project related efforts for the delivery of studies or programs that are critical to a product’s 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 RFP’s 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 8+ 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 in a fast-paced environment
- Creative problem solver
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Ability to travel as needed
- The salary range for this position is commensurate with experience
-
Senior Clinical Trial Manager
1 month ago
boston, United States Clinical Dynamix Full timeSenior Clinical Trial ManagerDescriptionReporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with...
-
Senior Clinical Trial Manager
2 months ago
Boston, United States Clinical Dynamix Full timeSenior Clinical Trial ManagerDescriptionReporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with...
-
Senior Clinical Trial Manager
2 months ago
Boston, United States Clinical Dynamix Full timeSenior Clinical Trial ManagerDescriptionReporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with...
-
Clinical Trial Manager, Start Up
2 weeks ago
Boston, MA, United States Clinical Dynamix Full timeClinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...
-
Project Manager
4 weeks ago
Boston, Massachusetts, United States Alliance for Clinical Trial in Oncology Foundation Full timeAbout the RoleThe Alliance for Clinical Trials in Oncology Foundation is seeking a highly skilled Project Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for managing the development, implementation, and oversight of assigned clinical trials.Key Responsibilities:Manage the development, implementation,...
-
Clinical Trial Manager, Start Up
2 months ago
boston, United States Clinical Dynamix Full timeClinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...
-
Clinical Trial Manager, Start Up
2 months ago
Boston, United States Clinical Dynamix Full timeClinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...
-
Clinical Trial Manager, Start Up
2 months ago
Boston, United States Clinical Dynamix Full timeClinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...
-
Senior Clinical Trial Manager
1 month ago
Boston, United States Leaman Life Sciences Full timeI am partnered with an exciting Gene Therapy biotech company based in Boston. They are expanding their team, looking for a Clinical Trial Manager / Senior Clinical Trial Manager. If you are interested, please feel free to apply through the link below or send me a message - natasha@leamanlifesciences.com
-
Senior Clinical Trial Manager
1 month ago
boston, United States Leaman Life Sciences Full timeI am partnered with an exciting Gene Therapy biotech company based in Boston. They are expanding their team, looking for a Clinical Trial Manager / Senior Clinical Trial Manager. If you are interested, please feel free to apply through the link below or send me a message - natasha@leamanlifesciences.com
-
Senior Clinical Trial Manager
1 month ago
Boston, United States Leaman Life Sciences Full timeI am partnered with an exciting Gene Therapy biotech company based in Boston. They are expanding their team, looking for a Clinical Trial Manager / Senior Clinical Trial Manager. If you are interested, please feel free to apply through the link below or send me a message - natasha@leamanlifesciences.com
-
Senior Clinical Trial Manager
1 month ago
boston, United States Leaman Life Sciences Full timeI am partnered with an exciting Gene Therapy biotech company based in Boston. They are expanding their team, looking for a Clinical Trial Manager / Senior Clinical Trial Manager. If you are interested, please feel free to apply through the link below or send me a message - natasha@leamanlifesciences.com
-
Senior Clinical Trial Manager
3 weeks ago
Boston, United States Fairway Consulting Group Full timeOur client is a biotechnology company developing treatments to target cancer. They have asked us to assist them in their search for a Senior Clinical Trial Manager. Major tasks and responsibilities include: Oversees assigned clinical trial(s) to ensure deliverables are met in all phases of trials. Oversees trial feasibility process and site feasibility and...
-
Senior Clinical Trial Manager
4 weeks ago
Boston, Massachusetts, United States X4 Pharmaceuticals Full timeSenior Clinical Trial ManagerX4 Pharmaceuticals is seeking a highly skilled Senior Clinical Trial Manager to join our Clinical Operations team. As a key member of our team, you will play a crucial role in the day-to-day management and execution of clinical trials.Key Responsibilities:Manage and oversee clinical trial operations, including CRO and third-party...
-
Clinical Trial Manager
2 weeks ago
Boston, MA, United States Beacon Hill Full timePosition Overview: Reporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management for a first-in-human trial in both healthy volunteers and patients. This person will manage cross-functional relationships with internal and external stakeholders and be the primary driver of all clinical study related...
-
Clinical Trial Manager
2 weeks ago
Boston, MA, United States Beacon Hill Full timePosition OverviewReporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management for a first-in-human trial in both healthy volunteers and patients. This person will manage cross-functional relationships with internal and external stakeholders and be the primary driver of all clinical study related...
-
Senior Clinical Trial Manager
3 weeks ago
Boston, United States X4 Pharmaceuticals Full timeSenior Clinical Trial ManagerReporting to:Vice President, Clinical Operations Do you have the passion and commitment to join a team whose mission is to develop treatments that have a clear and profound impact on people with rare diseases? Does it excite you to be a part of a company developing potential new treatments that could dramatically improve the...
-
Senior Clinical Trials Study Manager
4 weeks ago
, MA, United States Quest Diagnostics Incorporated Full timeJob SummaryThe Senior Clinical Trials Study Manager is responsible for coordinating the execution of clinical trial projects, including managing scope, timeline, and budget. This role will also have direct line management responsibility for junior-level study management team members.Key ResponsibilitiesLead process improvement and development for the site,...
-
Senior Biostatistician
1 month ago
Boston, United States Piper Companies Full timePiper Companies is currently seeking an experienced Biostatistician to join a well-established, global clinical research organization focused on improving the drug development process and access to therapeutics. The role is mostly remote with some hybrid responsibilities when necessary. Die to this the candidate must be located in the Boston, MA...
-
Senior Manager, Clinical Trial Management
1 week ago
Waltham, MA, United States Upstream Bio Full timePosition Summary:Upstream Bio seeks a resourceful, data-driven and integrative thinker for an important role overseeing clinical vendors supporting one or more of our clinical trials. This key role will plan, oversee and drive high quality end-to-end clinical trial vendor delivery in a fully outsourced model to ensure data integration across clinical trial...
