Senior Clinical Trial Manager

Reporting to the Senior Director, Clinical Operations, the Senior Clinical Trial Manager for Phase IV/Post-Marketing is responsible for leading Medical Affairs post-marketing studies. Candidate needs to hit the ground running, with all the key aspects of teamwork, collaboration and work ethic.

This role is specifically for a high-profile phase IV study.

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 may be based in Waltham, MA, which would be a hybrid role, or it can also be fully remote (remote for out of state candidate). Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.

Responsibilities (including, but not limited to):

• Accountable for project related efforts for the delivery of studies or programs 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 program 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.

Qualifications:

• 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