Clinical Trial Operations Manager

hace 4 semanas

Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo

**Clinical Trial Management Role**

At Syneos Health Clinical, we are seeking a skilled Clinical Trial Manager to oversee site management, clinical monitoring, and central monitoring deliverables for our clients. As a Clinical Trial Manager, you will be responsible for ensuring patient safety, protocol/GCP/regulatory compliance, and data integrity.

**Key Responsibilities**

  • Responsible for site management oversight, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.
  • Oversees site interactions post-activation through site closeout, including patient recruitment, investigator payments, and other related activities.
  • Identifies critical data and process, protocol execution risks, and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
  • Reviews the study scope of work, budget, and protocol content to ensure the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters.
  • Uses prior clinical experience, operational data, metrics, and reports to identify risks to clinical trial management deliverables.
  • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality, and budget) and any activities and requests that are out of contracted scope.
  • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
  • Participates and presents in key meetings, such as the Kick Off Meeting.
  • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members.
  • Collaborates with other functional leaders, such as Study Start Up, Patient Recruitment, and Data Management, to coordinate delivery handoffs and meet expected study milestones.
  • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
  • Ensures CTMS, dashboards, and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed.
  • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans, and guidelines.
  • Oversees resourcing allocations for CRAs and Central Monitors, site assignments, and study team members' conduct, and identifies risks to delivery or quality.
  • Ensures quality of the clinical monitoring, central monitoring, and site management deliverables within a project and maintains proper visibility of its progress by the use of approved systems and/or tracking tools.

**Why Syneos Health Clinical**

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

We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we're able to create a place where everyone feels like they belong.

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