Clinical Trial Manager

LabcorpCarlsbad, CA
Remote

About The Position

Labcorp is a global leader in diagnostic testing and drug development solutions, helping healthcare providers, researchers, and patients make informed decisions that advance care. Join us in our mission to improve health and improve lives. Labcorp is seeking a US based remote Clinical Trial Manager to join our team! Job Responsibilities: The Clinical Affairs Clinical Trials Manager (CTM) plays a pivotal role within our organization, and oversees the successful planning, initiation, coordination, and execution of clinical trials, fundamentally contributing to groundbreaking advancements in laboratory diagnostics and patient care. This role is essential in ensuring that all team members contributing to the study act consistently in their effort to verify that clinical trials are conducted in adherence to stringent regulatory standards, Good Clinical Practice (GCP) guidelines, and ethical norms. CTM’s are tasked with a wide variety of responsibilities, ranging from protocol and database development, site identification, contracting and budget negotiation, ensuring data integrity within the study and from the supporting labs providing assay results, liaising with cross-functional teams, ensuring subject safety, and may have a direct role in overseeing trial sites at a monitoring level. The ideal candidate will possess a robust blend of scientific knowledge, meticulous attention to detail, and exceptional organizational and communication skills with an ability to manage and lead a study team.

Requirements

  • Bachelor’s degree
  • 3 or more years of experience in clinical research
  • 3 or more years of experience with Microsoft Excel and Microsoft Word
  • Ability to effectively manage projects, maintain timeline and budget while achieving study objectives
  • Ability to effectively communicate both verbal and written skills
  • Ability to work independently, within prescribed guidelines, or as a team member

Nice To Haves

  • 3 or more years of experience in diagnostics
  • 3 or more years of experience with device regulations for 510k and/or PMA submissions
  • 3 or more years of experience with clinical protocol design
  • 3 or more years of experience managing clinical study programs
  • 3 or more years of experience with implementing clinical database management software

Responsibilities

  • oversees the successful planning, initiation, coordination, and execution of clinical trials
  • ensuring that all team members contributing to the study act consistently in their effort to verify that clinical trials are conducted in adherence to stringent regulatory standards, Good Clinical Practice (GCP) guidelines, and ethical norms
  • protocol and database development
  • site identification
  • contracting and budget negotiation
  • ensuring data integrity within the study and from the supporting labs providing assay results
  • liaising with cross-functional teams
  • ensuring subject safety
  • overseeing trial sites at a monitoring level

Benefits

  • Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.
  • Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan.
  • Employees who are regularly scheduled to work a 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO.
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