Clinical Trial Manager with Regional and USA/Canada Focus
hace 1 día
Syneos Health Clinical is seeking a highly skilled 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.
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 and ensures the clinical project team (CRAs/CeMs) 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 which 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 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.
Syneos Health Clinical is committed to developing our people through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program.
We are dedicated to our Total Self culture, where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are committed 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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