Senior Clinical Trials Manager
3 weeks ago
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 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 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
• Medical, dental, and vision coverage with 100% of premiums paid by Company for employees and their eligible dependents
• Company paid insurance programs
• Short- and long-term disability coverage
• Life, Travel and AD&D
• 401(k) Company Match with immediate company vest
• Employee Stock Purchase plan
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