Clinical Research Manager - GU Oncology Program

• We are looking to hire a Clinical Research Manager to help develop, shape and grow the clinical research team. The Oncology research program is a fast-paced environment and the successful candidate will be an independent, detail-oriented individual with drive and focus. The candidate will be a proven leader with project management skills and mindset, experience in oncology clinical trials, and have the ability to consistently deliver results on a tight timeline. The candidate will have leadership skills and training experience to provide operational leadership to a group of Clinical Research Staff, including Clinical Research Supervisor(s), Protocol Project Manager(s), Senior Clinical Research Coordinator(s), Clinical Research Coordinators and Assistant Clinical Research Coordinator(s) (total program size of ~25 staff), while monitoring workload and productivity. Under the direction of the Associate Director, the Clinical Research Manager is responsible for strategic planning in order to meet program goals, along with ensuring all reporting and study milestones are met including recruitment targets, data entry timelines, budget and sponsor requirements. This position also requires the candidate to be responsive to Principal Investigators and scientific oversight committees. Experience collaborating with senior leadership and research staff is a plus. The success of the team is dependent on managing performance, maintaining morale, upholding consistency across disease programs in terms of workload and assignment management, as well as maintaining high quality customer service. To achieve service quality, the Clinical Research Manager will work closely with staff to identify areas in need of training and development, review, and refreshers. The Clinical Research Manager also works closely with the Associate Director to report and interpret performance and metric data. DEPARTMENT DESCRIPTION: The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is a national leader in oncology research. The HDFCCC clinical research program is a fast-paced program with a broad portfolio of clinical trials. The mission of the UCSF HDFCCC clinical research program is to provide patients and their families with streamlined access to cutting-edge cancer therapies, In addition to providing compassionate, patient-centered care, our team of clinicians and researchers is dedicated to improving outcomes for all patients. Responsibilities % of time Essential Function (Yes/No ) Key Responsibilities (To be completed by Supervisor) 25 Yes Supervises staff work assignments and schedules to meet clinical research goals and timelines. Meets regularly with assigned staff to set goals and ensure objectives are being met. Directly supervises subordinates' quality and quantity of work to ensure studies meet objectives and are compliant with all regulations. Advises employees regarding resolution of technical problems. Communicates and collaborates with cross-functional teams.
• Responsible for managing, training and providing operational leadership to a group of Clinical Research Staff (~6-8 direct reports of Clinical Research Supervisors, Senior Clinical Research Coordinators, and CRCs), while monitoring workload and productivity.
• Develop, shape and grow the clinical research team.
• Work closely with staff to identify areas in need of training and development, review, and refreshers.
• Manage performance of team.
• Maintain morale.
• Uphold consistency across disease programs.
• Manage workload and assignment management.
• Ensures staff is maintaining high quality customer service. 15 Yes Direct responsibility for delivery of key trial goals and objectives, including enrollment targets and outcome event adjudication. Monitors compliance with all policies and processes. Adheres to standards.
• Manage through others the clinical trials projects in our Thoracic Oncology research program.
• Develop, shape and grow the clinical research team .
• Project manage the oncology clinical trials, and have the ability to consistently deliver results on a tight timeline. 15 Yes Serves as the main liaison between clinical trials and program leaders. Proposes solutions to difficulties arising from multidisciplinary research, implements structural changes to maximize time efficiency within the constraints of limited resources.
• Collaborate with senior leadership and research staff.
• Work closely with the Associate Director to report and interpret performance and metric data. 15 Yes Oversees a trial from inception through completion, including approvals, initiation (site visit coordination), protocol implementation, data management, writing publications and finalization of sponsor requirements. Prepares and approves final clinical trial documents, including protocol, brochures, training, reports, presentations, safety advisories, and manuals.
• Under the direction of the Associate Director, the Clinical Research Manager is responsible for strategic planning in order to meet program goals.
• Ensure all reporting and study milestones are met including recruitment targets, data entry timelines, budget and sponsor requirements.
• Communicate with Principal Investigators and scientific oversight committees and be responsive to ongoing project / program needs. 5 Yes Interfaces with clinical monitors to review data accuracy, protocol violations and deviations, and regular updates to reporting. 5 Yes Administers fiscal, material and human resources within study budget. Plans and implements resource allocations to individual trials. Suggests ways to be more efficient. If necessary, requests additional resources. Manages revenue collection, invoicing, and reimbursement accounting. 5 Yes Reviews new budget proposals for feasibility with industry sponsors, creates internal budgets for grants, creates invoices, and reconciles budget spending and salary support. Reviews and monitors all research related charges to ensure budgetary compliance. 5 Yes Oversees and analyzes complex databases. Compiles data reports as needed. Provides team, investigators, and clinical fellows with guidance regarding study design and logistics (data collection forms, formatting of data, data management). Assists with publication of abstracts and manuscript. Viewed as an excellent resource for any related questions or concerns about the trial. 5 Yes Recommends salary actions, promotions, and terminations. Conducts necessary personnel actions for assigned staff including disciplinary actions. Recommends changes in staffing and changes to budget to ensure the efficient operation of the function. Participates in recruitment and orientation of new employees. 5 Yes Evaluates assigned staff performance and competency. Defines individual development goals. Mentors professional staff, including employees that are learning a new area of clinical practice. Encourages assigned staff to further their knowledge through clinical education, and certifications. 100% (To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.) MINIMUM

Bachelor's degree in related area. Clinical Trial Professional certification from a professional society within one year in position. Minimum of 5 years of related experience Minimum of 3 years of Lead/Supervisory/Manager experience Broad knowledge of clinical or laboratory research and clinical research philosophy.

Demonstrated ability to translate clinical research philosophy into business best practices in a trial setting. Demonstrated project management skills. Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment.

Adaptable to quickly changing priorities. Demonstrated experience managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others.

Demonstrated experience in training others in the field of research. Demonstrates good problem-solving and analytical skills. Creatively addresses complex or new problems.

Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to influence and negotiate.

Excellent interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals.

Ability to cultivate relationships with multiple stakeholders at various levels of administration. Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs.

Proven ability utilizing clinical trial management systems. Skills to work collaboratively with other cross-functional teams. Ability to interface and collaborate with other members of an extended study team.

Ability to influence / persuade. Proven ability to effectively coordinate and integrate programs with others in division, department, and organization. PREFERRED: Advanced degree preferred.

LICENSES/CERTIFICATIONS: Clinical Trial Professional certification from a professional society within one year in position.

Day shift