Independently manage all aspects of assigned clinical studies to ensure studies are completed on time, within budget, and in compliance with Good Clinical Practice (GCP), government regulations, and overall clinical objectives. Develop protocols, investigator brochures, and study reports, and assist in new drug applications.
Daily activities may vary depending on the clinical phase of the program and may support more than one study.
Manage contract research organization (CRO) personnel and study sites to ensure studies are completed on time, within budget, and in compliance with the protocol, GCP, FDA regulations, ICH guidelines, and overall clinical objectives.
Manage all study parameters, including clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out.
Supervise monitoring activities of study data verification on source documentation and case report forms (CRFs) to ensure compliance with study protocols, GCP, and SOPs. Ensure data discrepancies are identified and resolved.
Supervise on-site monitoring visits, including site qualification, initiation, interim, co-monitoring with CRO, and close-out visits. Review site visit reports.
Supervise activities related to the preparation of all study-related clinical documents, including informed consent forms, site training materials, CRFs, clinical monitoring plans, source document templates, and data audit worksheets.
Lead evaluation and selection of sites and CROs, and planning of clinical meetings (investigator meeting, steering committee meeting, CRO kick-off meetings, etc).
Assist in preparation of study protocols, clinical sections of INDs, and other regulatory submissions.
Assist in analysis of clinical trial data and prepare clinical study reports.
May be the lead clinical operation representative in project team meetings.
Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
Travel is required – up to 25%.
Other duties as assigned.
A BS, RN/PA, BSN degree, or equivalent, with 5+ years of sponsor clinical research experience in the biotechnology industry, of which at least 3 years must be industry in-house experience.
Demonstrated experience managing regional and in-house CRAs a plus.
Broad knowledge of GCP, ICH, and FDA regulatory requirements governing human clinical trials.
Proven ability to exercise independent judgment and use critical thinking to analyze problems which may require multiple factors and approaches.
Excellent technical writing skills.
Proven experience working in cross-functional project teams.
Experience with successfully managing multiple teams, external sites, and projects in a dynamic environment.
Excellent communication and interpersonal skills.
Personal attributes include:
Integrity and flexibility.
Proactive in identifying potential problems and seeking successful solutions.
Action- and goal-oriented.
Practical approach to clinical and regulatory processes.
Collaborative and team-oriented.
Excellent attention to detail.