Spain-Based Senior Clinical Operations Lead

Bayer

Barcelona

Remote

EUR 70,000 - 110,000

Full time

2 days ago
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Job summary

The Bayer Clinical Development & Operations team in Spain is seeking a Clinical Operations Manager 2 (COM2) to lead regional site management and study management for assigned trials (Phase I–IV). You will ensure compliance with ICH-GCP and Bayer SOPs, and collaborate with cross-functional teams to optimize study delivery.

Responsibilities include creating monitoring plans, leading site qualification, and supporting study start-up activities, with emphasis on data integrity and timely,

Qualifications

  • Healthcare related Bachelor's Degree or equivalent.
  • 4+ years of monitoring and site management experience; or 8 years with a combination of education.
  • Experience in Spain and fluent English/Spanish communication.
  • Fundamental project management, decision making and issue resolution skills.

Responsibilities

  • Lead and oversee site management activities at regional or study level.
  • Coordinate study start-up, monitoring plans, and investigator training.
  • Ensure compliance with ICH-GCP, regulatory requirements and Bayer SOPs.
  • Develop recruitment and retention strategies for trial sites.
  • Serve as primary contact for investigational sites.
  • Oversee monitoring activities and sponsor oversight via reports.
  • Maintain data quality and up-to-date TMF in country.

Skills

Project management
Decision making
Issue resolution
English communication
Spanish communication

Education

Healthcare related Bachelor's Degree or equivalent

Job description

The Bayer Clinical Development & Operations team in Spain is seeking a Clinical Operations Manager 2 (COM2) to lead regional site management and study management for assigned trials (Phase I–IV). You will ensure compliance with ICH-GCP and Bayer SOPs, and collaborate with cross-functional teams to optimize study delivery.

Responsibilities include creating monitoring plans, leading site qualification, and supporting study start-up activities, with emphasis on data integrity and timely,

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