Clinical Trial Manager II

🔥 1 hour ago

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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

• Collaborates with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plans logistics and resource usage. • Tracks study progress in alignment with project milestones, client deliverables, and budget, and follows applicable regulations globally and by region. • 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. • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. • Participates and presents in key meetings such as Kick Off Meeting.

🎯 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 • Demonstrates understanding of clinical trial management financial principles and budget management • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Must demonstrate good computer skills • Good communication, presentation and interpersonal skills among project team and with sites • Strong conflict resolution skills • Demonstrated ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project. • 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 • We are committed to building an inclusive culture – where you can authentically be yourself.