Senior Clinical Trial Manager

Senior Clinical Trial Manager

Location: Waltham, MA

Job 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.
• 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.
• Office-based employees are required to work in the office three (3) days a week.

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 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 the 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 of 8+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role.
• Exceptional communication and interpersonal skills.
• Positive team-oriented 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.