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Senior Clinical Trial Management Specialist

2 months ago


San Mateo, California, United States Maxonic Full time
Job Overview

Position Title: Senior Clinical Trial Management Specialist

Employment Type: Contractual Role

Location: Remote

Work Arrangement: On-site

Role Summary:

The Senior Clinical Trial Management Specialist plays a pivotal role in Clinical Operations, particularly within Biomarker and Bioanalytical Operations. This position demands a blend of educational qualifications and practical experience in life sciences.

Qualifications:

  • Advanced degree (MA/MS/PharmD/PhD) with a minimum of 2 years of relevant clinical or related experience.
  • Bachelor's degree (BA/BS) or Registered Nurse (RN) with at least 4 years of pertinent clinical or related experience.
  • Proven experience in overseeing external vendor operations.
  • Meets the criteria for the Clinical Trial Management Associate (CTMA) grade 25 position with demonstrated expertise.

Knowledge and Skills:

  • Ability to quickly grasp new concepts and adapt to changing environments.
  • Proficient in managing multiple projects and providing necessary support across various initiatives.
  • Comprehensive understanding of the complete clinical study management lifecycle, from initiation to conclusion, with a focus on achieving desired outcomes.
  • Extensive industry knowledge and familiarity with regulatory standards including FDA and EMA guidelines, ICH standards, and Good Clinical Practice (GCP).
  • Strong command of medical and scientific terminology.
  • Excellent communication skills, both verbal and written.
  • Capacity to thrive in a collaborative, matrixed environment.
  • Adept at managing several tasks concurrently.
  • Willingness to travel as required.

Key Skills:

  • Experience in sample management.
  • Strong proficiency in Microsoft applications.
  • Exceptional communication abilities.

Desirable Skills:

  • Experience in clinical operations or bioanalytical operations.
  • Laboratory (bench) experience.

Unique Aspects of the Role: This position offers the opportunity to collaborate with a diverse and cross-functional team.

About Maxonic

Since its inception in 2002, Maxonic has excelled in aligning candidate strengths with client needs. Our award-winning team of recruitment professionals specializes in technology and is committed to understanding and fulfilling the long-term career aspirations of our candidates. We take pride in our track record of placing over 5,000 candidates and the enduring relationships we maintain with our satisfied clients.