Senior CTM/AD, Clinical Operations

144181
  • 160000 USD - 200000 USD
  • Waltham, United States
  • Permanent

? Exciting Opportunity in Clinical Operations! ?

Are you passionate about advancing medical treatments for rare diseases? We're seeking a talented Senior Clinical Trial Manager (SCTM) or Associate Director (AD) to join our team and play a pivotal role in managing clinical trials for a novel precision kinase inhibitor.

Please note - This role is onsite 2 days weekly in Waltham, MA

Responsibilities:

  • Support implementation of clinical research studies within budget and schedule.
  • Manage vendors and investigators to ensure protocol compliance and clinical objectives.
  • Coordinate and lead study team meetings, keeping stakeholders updated on timelines and milestones.
  • Train team members and site staff, contributing to study documentation development.
  • Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning and report writing.
  • Support vendor evaluation and contract negotiation.
  • Perform clinical research site activities, including monitoring and oversight visits.
  • Ensure study documentation complies with regulations and SOPs.
  • Collaborate with cross-functional teams to ensure regulatory compliance.

Qualifications:

  • BS/BA Degree in science or health-related field preferred.
  • 4-6 years of industry clinical development experience.
  • Experience with complex therapeutic platforms and rare disease/oncology clinical trials.
  • Familiarity with GCP, ICH, and FDA regulations.
  • Excellent SOP review and development skills.
Paige Pecora Senior Dvision Manager

Apply for this role

Not registered? Create your account or if you already have an account? Sign in here

Meet Recruitment 2022. Meet Recruitment Ltd., Meet Recruitment Inc. and Meet Personalberatung GmbH are all subsidiaries of Meet Group (No. 13556131) a company registered in England and Wales at Irongate House, 22-30 Dukes Place, London, EC3A 7LP.
Site by Venn