Clinical Trial Management Lead

hace 5 días


Colombia Syneos Health, Inc. A tiempo completo

Job Description

Syneos Health, Inc. is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

We are seeking an experienced Clinical Trial Manager to oversee site management, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity. The successful candidate will be responsible for site interactions post-activation through site closeout, including patient recruitment, investigator payments, and other related activities.

The ideal candidate will have demonstrated expertise in site management and monitoring (clinical or central), preferably with experience in risk-based monitoring. They must also have knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.

In this role, you will lead and align teams in the achievement of project milestones, working collaboratively with cross-functional departments to ensure seamless delivery. You will also be responsible for developing and maintaining clinical study tools and templates, ensuring CTMS, dashboards, and other systems are set up and available for use by the clinical team.

Key Responsibilities:

  • Oversee site management oversight, clinical monitoring, and central monitoring deliverables
  • Responsible for site interactions post-activation through site closeout
  • May be responsible for identification of critical data and process risks and risk mitigations
  • Reviews the study scope of work, budget, and protocol content
  • Escalates risks to clinical trial management deliverables to the project manager
  • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations
  • Participates in key meetings such as Kick Off Meetings

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