Clinical Research Manager

Responsibilities

• Responsible for achievement of clinical research objectives.
• Provides operational, clinical, and administrative leadership, direction and oversight for all clinical research operations.
• Maintains the integrity of clinical research and ensures participant safety through management and oversight of staff.
• Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
• Interprets and applies all relevant scope of practice standards to develop clinical research processes, policies and guidelines.
• Responsible for overall implementation and compliance of research program.
• Works with Program Director to determine appropriate staffing levels based on operational needs.
• Develops strategies including methods and techniques to achieve the goals of the study and assure that standards are met.
• Develops systems and supervises Regulatory Specialist to ensure IRB submissions, monitor visits, study start-up, and regulatory files are managed in a timely, efficient manner.
• Develops trial and overall research evaluation strategies.
• Manages action plan(s) when standards are not met.
• Manages program resources and oversees resource management.
• Works with upper management, team members, sponsors, department, and Clinical Trials Office to develop study budgets.
• Presents program budgeting projections to leadership and develops short and long term financial plans.
• Regularly interacts with senior management on matters concerning clinical research for the Clinical Trials Program, including controversial situations, negotiations, or issues that require influencing or persuading others in order to move clinical research agenda forward.
• Actively promotes the role of clinical research within the organization and in other institutions and committees.
• Represents the department to the industry and the community via participation in national and international meetings and professional groups.
• Approves salary actions, promotions, hires, reclasses, and terminations.
• Develops plan for onboarding and training new team members.
• Supervises research team, including regulatory/finance/admin specialists and clinical research coordinators.
• Reviews personnel actions, evaluates performance, and ensures compliance with HR standards including the most complex, sensitive disciplinary actions.
• Approves or rejects staffing requests, justifying how staffing patterns meet department needs.
• Develops employee evaluation processes that meet organization standards.
• Develops standards for training, supervising, and evaluating employees that also meet organization standards.
• Includes critical training focus on participant safety, regulatory compliance, and research ethics for team members.
• Identifies the need for continuing education programs for staff, such as best practices for working with participants with cognitive and behavioral issues.

Qualifications

• Master's degree in related area and / or equivalent experience / training.
• Minimum requirements of eight years related experience including at least seven in a lead/supervisory role.
• In depth academic knowledge and applied background in clinical research philosophy as evidenced by at least 2 years of experience successfully running complex clinical research trials.
• In depth knowledge of clinical research and drug development concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials.
• In depth theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research.
• Excellent ability to establish collegial and productive relationships with prominent clinical investigators, research partners, industry and key opinion leaders in relevant therapeutic areas in order to develop and apply the strategic intent of the study.
• Excellent skills to work collaboratively and act persuasively in sensitive situations; skills in conflict management techniques.
• Excellent ability to quickly evaluate complex issues and identify multiple options for resolution.
• Takes initiative and responsibility.
• Able to solve problems when no precedent exists.

About UCSF

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world’s leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

Salary Information

The final salary and offer components are subject to additional approvals based on UC policy. Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.