Senior Clinical Research Operations Manager

hace 1 día


Madrid, Madrid, España Syneos Health A tiempo completo
About Syneos Health

At Syneos Health, we're a leading biopharmaceutical solutions organization that translates unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

We're committed to simplifying and streamlining our work to make Syneos Health easier to work with and for. Our Clinical Development model puts the customer and patient at the center of everything we do.

Join us in a fully integrated environment where you'll collaborate with passionate problem solvers to innovate as a team and help our customers achieve their goals. We're agile and driven to accelerate therapy delivery because we're passionate about changing lives.

Our Culture

We're passionate about developing our people through career development and progression, supportive line management, technical and therapeutic area training, peer recognition, and total rewards programs.

Our Total Self culture is what unites us globally, and we're dedicated to taking care of our people. We continuously build the company we all want to work for and our customers want to work with by bringing together diversity of thoughts, backgrounds, cultures, and perspectives.

About the RoleJob Summary:

The Senior Clinical Research Operations Manager performs site qualification, initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

  • Evaluates overall site performance and provides recommendations for site-specific actions.
  • Maintains working knowledge of ICH/GCP guidelines, relevant regulations, and company SOPs/processes.
Duties and Responsibilities:

This role involves:

  • Verifying informed consent process and documentation.
  • Assessing factors affecting subject/patient safety and clinical data integrity.
  • Conducting source document reviews and verifying CRF data accuracy.
  • Applying query resolution techniques remotely and on-site.
  • Utilizing hardware and software to support clinical project data review and capture.
  • Ensuring site compliance with electronic data capture requirements.
  • Performing IP inventory, reconciliation, and reviews storage and security.
  • Routinely reviewing the ISF for accuracy, timeliness, and completeness.
  • Supporting subject/patient recruitment, retention, and awareness strategies.
  • Entering data into tracking systems and managing site-level activities/communication.
Requirements:

To succeed in this role, you'll need:

  • Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Excellent computer skills and ability to adapt to new technologies.
  • Strong communication, presentation, and interpersonal skills.
  • Ability to manage required travel of up to 75% on a regular basis.
About the Salary

The estimated salary for this role is around $80,000 - $110,000 per year, depending on location and experience.

Additional Information

Please note that tasks, duties, and responsibilities may be added or modified at any time, and equivalent experience, skills, and/or education will also be considered.



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