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Senior Clinical Trials Manager

4 months ago

Waltham, United States Clinical Dynamix, Inc. Full time
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 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