Clinical Trials Manager (CTM)

Location
Boulder, Colorado
Salary
Commensurate with experience
Posted
Feb 15, 2018
Required Education
Bachelors Degree
Position Type
Full time

The Clinical Trials Manager I/II is responsible for leading the execution of clinical studies on schedule and on budget. Primary responsibilities include:

  • Oversee the delivery of large studies or programs critical to a product’s clinical development to ensure that they are completed on time, within budget and in compliance with SOPs, FDA and global regulations and ICH/GCP guidelines Responsible for external vendor selection and management, and assists in the development of RFPs and vendor oversight plans Provide clinical leadership to CROs, other vendors, CRA team, CRMs and CTAs Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones May manage staff and 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 Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA) Travel required: up to 25%

Qualifications

BA/BS degree in Health or Life Sciences required, advanced degree preferred, and a minimum 5 years of experience in a Clinical Trials Manager role.

Required Skills and Abilities

  • Exceptional communication and interpersonal skills
  • Advanced proficiency in Microsoft Office
  • Reliable, self-motivated, team player
  • Detail oriented with excellent organizational skills
  • Ability to effectively manage multiple tasks and competing priorities