Clinical Research Manager

Job Summary:

We are looking to hire a Clinical Research Manager to help develop, shape and grow the clinical research team in the GI Oncology research program. The Heme Malignancy 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), Senior Clinical Research Coordinator(s), Clinical Research Coordinators and Assistant Clinical Research Coordinator(s) (total program size of ~ 14 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 Overview:

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 Our team of clinicians and researchers is dedicated to improving outcomes for all patients.

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.

Pride Values

UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values.

In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available here.

Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

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.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

Minimum Requirements:

• 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.

License/Certification:

• Clinical Trial Professional certification from a professional society within one year in position

%

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

YesInterfaces with clinical monitors to review data accuracy, protocol violations and deviations, and regular updates to reporting.

5

YesAdministers 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

YesReviews 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

YesOversees 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

YesRecommends 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

YesEvaluates 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%.)

%

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

YesInterfaces with clinical monitors to review data accuracy, protocol violations and deviations, and regular updates to reporting.

5

YesAdministers 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

YesReviews 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

YesOversees 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

YesRecommends 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

YesEvaluates 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%.)