Clinical Trial Manager, Site Start-Up Position

4 weeks ago


Waltham, Massachusetts, United States Viridian Therapeutics Full time
Job Summary

Viridian Therapeutics, Inc. is seeking a highly skilled Clinical Trial Manager, Site Start-Up to lead the end-to-end start-up, site initiation, and site activation process for multiple complex studies. This role requires strong collaboration with key stakeholders, expertise in study start-up practices, and a focus on efficient start-up activities and obstacle removal.

Key Responsibilities
  • Study Start-Up Planning: Develop and implement site initiation management plans, coordinate regulatory and ethics committee submissions, and manage day-to-day study start-up activities.
  • Regulatory Compliance: Prepare local and independent ethics committee submissions, respond to queries, and ensure compliance with regulatory requirements, GCP, and company SOPs.
  • Site Management: Oversee the informed consent process, translate study required documents, and participate in the development of study start-up plans.
  • Contract and Budget Negotiations: Coordinate contract and budget negotiations between sites and internal functions, and coordinate investigational product release authorization with quality assurance.
  • Project Management: Implement and monitor the progress of the study initiation plan, prepare and participate in project update meetings, and create, manage, and archive central startup team tools and resources.
Requirements
  • Education: BA/BS degree in Health or Life Sciences required, advanced degree preferred.
  • Experience: A minimum of 5+ years of experience in Clinical Operations roles, with a heavy concentration in clinical trial management and monitoring within the Pharmaceutical and/or Medical Device Industry.
  • Skills: Advanced proficiency in Microsoft Office and Microsoft Project or Smartsheets, proficient with Microsoft Office suite, and ability to travel up to 10%.
Benefits
  • Competitive Pay and Stock Options: Competitive pay and stock options for all employees.
  • Health Insurance: Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents.
  • Employee Benefits: Fertility and mental health programs, short- and long-term disability coverage, life, travel, and AD&D, 401(k) Company Match with immediate company vest, Employee Stock Purchase plan, generous vacation plan, and paid company holiday shutdowns.

Viridian Therapeutics, Inc. is an equal employment opportunity employer and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws.



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