Clinical Research Project Lead

Job Description Summary

We are seeking a Clinical Research Program Lead who will be responsible for the overall management of the observational research portfolio and associated research activities of the Parkinson's Disease and Movement Disorders Center (PDMDC), part of the Department of Neurology. This center is located at Pennsylvania Hospital.

Job Description

The Clinical Research Program Lead will manage the clinical research study team, providing training, mentoring, management of workload assignments, and oversight of coordinator responsibilities. They will be responsible for all aspects of hiring, on boarding, and training and will provide coverage during absences. They will take a leadership role in strategizing the direction of growth for the team, initiating new projects and processes, developing study documents and staff resources, managing the detailed operations of the studies, and coordinating activities with internal and external partners. They will develop, create, and review study source documents, regulatory submissions, annual reports, and training documents, as applicable. They will also develop and maintain standard operating procedures for the team. They will ensure that studies are being conducted safely and according to the protocol while maintaining quality control and meeting milestones.

They will oversee the start-to-end processes for study start-up and ongoing study management. This includes assisting with study feasibility and selection, prioritization of the study team's work, working closely with the study team and investigators to manage, review, and initiate studies/trials to ensure competitive activation and enrollment timelines as well as facilitate timely study closure. They will work closely with the business office to oversee the finances of the department and work on study budgets and invoicing.

The Clinical Research Program Lead will report directly to the Director, Parkinson Foundation Center of Excellence, Parkinson's Disease and Movement Disorders Center, and indirectly to the other investigators within the team. They will collaborate closely with the Clinical Research Program Lead of the PDMDC Clinical Trials team as well as with external departments/stakeholders to support day to day operations of the study team.

Qualifications

• Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience is required. Master's degree and 3-5 years of experience preferred.
• Demonstrated complex problem solving abilities
• Excellent communication and writing skills
• Strong organizational and time management skills
• Flexible, detail oriented, organized, and able to multi-task
• Demonstrated ability to work as part of a team, as well as independently
• Strong innovative skills
• Able to work collaboratively on all levels and to gain support of others
• Able to develop interdepartmental relationships and form solid collaborations
• Able to confidently interact with all levels of management including senior management, physician leaders and others
• Knowledge of IRB and human research protection regulations.