Clinical Trial Manager II

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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 • May be responsible for identification of critical data and process, protocol execution risks and risk mitigations • Reviews the study scope of work, budget and protocol content and ensures the clinical project team 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 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 • Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones • Reviews and provides feedback on other functional plans as they relate to clinical trial management activities • Responsible for development and ongoing maintenance of clinical study tools and templates • Ensures systems are set up and available for use by the clinical team, including overseeing user acceptance testing as needed • Ensures access and audit trail reviews are conducted as required • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form completion, dashboards, clinical plans and guidelines • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct • Ensures quality of the clinical monitoring, central monitoring and site management deliverables • Reviews the project oversight dashboards and other clinical trial systems to oversee site and patient activities

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience • Demonstrated ability to lead and align teams in the achievement of project milestones • Demonstrated capability of working in an international environment • Demonstrated expertise in site management and monitoring (clinical or central) • Preferred experience with risk-based monitoring • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Must demonstrate good computer skills • Strong conflict resolution skills • Demonstrated ability to apply problem solving techniques to resolve complex issues • Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues • Moderate travel may be required, approximately 20%

🏖️ Benefits

• 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 • Committed to building an inclusive culture – where you can authentically be yourself