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

• 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.

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