Manages clinical trials and provides therapeutically aligned, scientific strategy and operations management for the planning, execution and reporting of clinical development programs to enable successful global registration and commercialization of drug development projects. Areas within Clinical Operations include clinical program and study management, monitoring, document management, medical writing, safety management, clinical planning and resource management, systems support, “ Standard Operating Procedure” training and compliance, and continuous improvement program management.
Project manager responsible for the overall execution of clinical trial(s) from study concept through study completion.
May have direct reports and matrix management of assigned study team(s) to ensure compliance and execution on timelines and deliverables.
Aware of both internal and external business environments, assess impact on clinical studies and make modifications as necessary.
Escalate performance issues to management with plans for resolution and ensure coordination/sharing of information within the therapeutic area.
Responsible for compliance with applicable Corporate and Divisional policies and procedures.
Manage the implementation, on-time execution and conduct of clinical studies including the development of the Study Plan, key milestones, timelines, study costs, vendor selection and resource needs as well as ensuring quality and compliance.
Provide input on regulatory documents (e.g., Investigator’ s Brochure (IB), CSR, and the IND/DSUR).
Effectively communicate study progress and actively identify issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions or solutions to manage the issues.
Bachelor’ s degree or equivalent is required, typically in nursing or scientific field. An Associate’ s degree/R.N. or equivalent with relevant experience is acceptable.
Must have 6+ years of pharmaceutical related / clinical research related experience.
Must have demonstrated a high level of core and technical competencies through management of clinical trials.
Possess good communication skills and demonstrated leadership abilities.
Demonstration of successful coaching/ mentoring in a matrix environment.
Competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
Preferred exposure in study initiation through study completion in multiple phases of studies (Phase 1-3, 4).
Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
Learns, fast, grasps the ' essence' and can change the course quickly where indicated.
Raises the bar and is never satisfied with the status quo.
Creates a learning environment, open to suggestions and experimentation for improvement.
Embraces the ideas of others, nurtures innovation and manages innovation to reality.