About this role

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, which may include patient recruitment, investigator payments or other related activities.
Reviews the study scope of work, budget and protocol content and ensures 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 and escalates any risks to the project manager.
Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones.

Experience in project management and previous experience as CRA
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
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%.

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.

Clinical Trial Manager II – Project Management, CRA

Key skills