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 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/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)
Employs strategic thinking and problem-solving skills to propose and implement risk mitigations
Participates and presents in key meetings
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

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
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

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

Clinical Trial Manager

Key skills