Clinical Operations Manager

hace 2 semanas

Ciudad de México, Ciudad de México Syneos - Clinical And Corporate - Prod A tiempo completo

About Syneos Health

At Syneos Health, we are dedicated to accelerating life-changing medical therapies and solutions.

We are a leading fully integrated biopharmaceutical solutions organization that brings together clinical development and commercialization services to help our customers deliver therapies to patients faster.

Our team is passionate about developing innovative solutions that meet the evolving needs of our customers and patients.

Job Summary

The Senior Clinical Operations Specialist will be responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions.

This includes assisting Clinical Monitoring staff with site management activities, such as serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines.

Key Responsibilities

  • Create and assist with maintenance of project files, handle project correspondence
  • Participate in file audits
  • Prepare and maintain site manuals, reference tools and other documents
  • Maintain, update, and input clinical tracking information into databases
  • Track incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
  • Manage shared mailbox, process site requests and route correspondence appropriately
  • Coordinate the ordering, packaging, shipping and tracking of site supplies and materials
  • Assist with coordination of team meetings, attend meetings and prepare accurate meeting minutes and action items
  • Routinely anticipate, identify and resolve potential issues and implement corrective actions, seeking guidance as needed to resolve more complex issues
  • Maintain overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training
  • May provide training or mentorship to more junior level Clinical Operations Specialists (COS)

Qualifications

To be successful in this role, you will need:

  • Associate's degree preferred or equivalent
  • Experience in clinical research/pharma/biotech or related field considered In lieu of degree
  • Good knowledge of medical terminology, clinical data, and ICH/GCP preferred
  • Ability to successfully prioritize and work on multiple tasks
  • Strong attention to detail, accuracy and organizational skills
  • Excellent communication, presentation, and interpersonal skills
  • Ability to embrace new technologies
  • Minimal travel up to 10% may be required

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