Description

Manager, Study Coordination

General Summary This position is responsible for the oversight, scheduling, training, and mentoring of individual contributors in the execution and quality compliance of project work in Preclinical Operations. The Manager, Study Coordination and QC is responsible for ensuring work completion meets budget, timeline, and quality standards. This position directly supervises Quality Control and Study Coordinators, and works directly with the staff, Project Managers, and Study Directors, to create integrated study plans and implement those plans to meet business objectives. Essential Duties & Responsibilities

• Manages and leads an effective team to include oversight for day-to-day direction of work tasks, staff training, and development.
• Works collaboratively with Study Directors, Project Managers, Proposals and other internal staff to support project costing, initiation, execution, reporting, and tracking.
• Manages staff to provide work and services that are on time, within budget, and of high quality.
• Monitor and direct effectiveness and efficiencies of end-to-end quality in process flows.
• Establish quality matrices to better track and improve quality across all operational groups.
• Participates in pre-study meetings, as needed, to understand project requirements; assign Project Coordinator to specific projects; provide work direction; prepare reporting schedules; and set deadlines.
• Utilizes effective time management techniques to ensure task deadlines are met. Interface within and across departments, as needed, to facilitate timely completion of all project-specific tasks
• Monitors study progress and communicate potential financial impact to advise study director, project manager, and departmental director of any issues or concerns observed.
• Participates in the development of study-specific costing by providing hours necessary for workload per project as requested.
• Participates in the development of the departmental budget. Maintains operational calendars for
• Oversees and maintains Provantis data collection software. Supervises data extraction from data collection software and the preparation of study protocols and amendments; draft, final, and amended final reports; review work generated by staff to confirm quality control and accuracy.
• Participates in post-project meetings to evaluate the effectiveness of study protocols, amendments, and reports utilized and to make or hear recommendations for improvement. Disseminate information to direct reports as appropriate.
• Responsible for effective communication of department and division information to staff. Effectively represents leadership decisions to staff.
• Author, update, and review area-specific Standard Operating Procedures (SOPs), ensuring that SOPs reflect current practices.
• Identifies staffing requirements and other resource projections. Initiate actions to interview and hire staff; provide input to the salary review process including recommendations for promotion. Provide performance feedback regarding work tasks and take appropriate actions to improve employee performance, Complete performance reviews and discipline actions.
• Demonstrates a good working knowledge of basic principles of supervision.
  • Facilitate a teamwork environment that embraces diversity.
  • Recognize positive performance in a timely fashion.
  • Identify and resolve conflicts in a timely fashion.
  • Identify and address performance issues in a timely fashion.
• Ensures appropriate safety standards are in place, utilized, and monitored.
• Demonstrates good business ethics.
• Supports clinical trial activities, as needed, for affiliates.

Requirements/Minimum Qualifications

• Education & Experience:
  • Bachelor's degree and 5 years of study coordination experience and QC experience
• Influenza vaccination, and possibly others depending on agents in the lab

Core Values Cultivating human connection putting people first. We know that every individual makes a difference and that no one can do it alone. We believe the world's most powerful resource is human potential. We are an inclusive and courageous team where innovation and diversity of though go hand in hand. We understand that relationships move at the speed of trust. Operating with precise execution measuring what matters and owning results as a team. We leverage data to drive decisions that advance science. We recognize the importance of a stable foundation coupled with an agile mindset. We hold ourselves accountable and take pride in our work. We give and receive candid feedback as a gift that keeps us growing. Harnessing relentless curiosity our unstoppable, innovative force. We are driven to ask sharp questions and push the boundaries of knowledge. We use creativity and critical thinking as catalysts for finding solutions that change lives. We learn by doing, consistently striving to improve our relationships, training, methodologies, questions and results. Stewarding a healthy community implementing sustainable operations for a safe, engaging environment. We don't compromise on safety and health for our employees, customers or community. We believe a healthy community begins with inclusive economic opportunities. We respect the dignity of the patients we ultimately serve. We are motivated to serve communities that are underserved and markets that are overlooked. Job Specific Behaviors Builds/Maintains Winning Teamwork - Creates a success climate; empowers others. Is receptive to ideas and input from others and leverages diversity; respects others, inspires trust, and acts with Integrity. Coaches / Develops Others - Selects for talent. Sets expectations and provides clear and timely feedback. Motivates, develops self and others to foster a learning environment and openly shares information that would guide others. Uses appropriate interpersonal style to guide direct reports to action. Selects talent, sets expectations, provides clear feedback, motivates, develops self and others; fosters a learning environment; recognizes performance success. Communicates with Impact - Expresses thoughts and ideas effectively in individual and group situations; adjusts language to the needs of the audience. Ideas are clearly defined in grammatically correct written communication. Technical/ Operational Excellence - Ensures that the work product'(whether service or process) enables the organization to deliver on customer's expectations. Possesses and applies professional/ technical knowledge, skills, experience, and judgment to accomplish a result. Planning and Organization - Systematically identifies issues to be addressed and plans a course of action for self and others to ensure the accomplishment of specific objectives. Physical Demands/Work Environment & Conditions This position involves the ability to work both in an office and technical laboratory environment The ADA requirements for the position involve wearing the appropriate PPE, completing medical examinations, ability to take experimental vaccines, etc. Certifications, Licenses & Registrations

• None required

PI280504625