Data Safety and Monitoring Manager

Data Safety and Monitoring Manager – 35075 University Staff

Description

University of Colorado Anschutz Medical Campus

Department: Cancer Center

Working Title: Data Safety and Monitoring Manager

Position #: 699241 – Requisition #35075

Job Summary:

Examples of Work Performed:

Program Management and Administration:

Oversees all data and safety monitoring programs and activities required to maintain UCCCs standing as a National Cancer Institute (NCI)-designated Comprehensive Cancer Center.

Manages unit operations to assure adherence to all research standards set forth by the NCI, FDA, OHRP and institution.

Reviews all protocols conducted through the CU Cancer Center, as a component of the PRMS submission/review process to ensure trial oversight requirements are properly categorized and that all investigator-initiated trials have adequate safety oversight in relationship to the trials risk.

Coordination and organization of all preparatory and post-audit activities including approving audit reports and escalating unacceptable findings as needed.

Maintains DSMC-relevant data within the OnCore® clinical trial management system.

Prepares and facilitates all DSMC meetings.

Facilitates the review of all SAEs, UAPs and DSM Progress Reports received by the DSMC and manages the documentation for review by the NCI as required.

Responsible for strategic planning for the effective deployment of program oversight mechanisms and manages the goals and output of all operational components.

Manages DSM budget to ensure effective allocation of funds and unit services.

Leads DSM administrative efforts to manage unit goals and outcomes.

Process Improvement, Guidance Development, and Collaboration :

Leads compliance operations by developing, managing, and supervising implemented processes and procedures employed by UCCC member investigators and staff.

Interprets policies, standards, and regulations, and evaluates potentially critical problems not covered by policies, standards, and regulations.

Recommend strategies and draft policies and processes to support necessary oversight activities; work with the DSMC Chair, DSM Committee, Quality and Compliance Program Director, Cancer Center clinical and administrative leadership to develop consensus and support for policies and processes across the various constituencies within the Cancer Center.

Ensures continuous process improvement and compliance. Subject matter expert to internal and external audiences regarding policies, procedures, and activities relevant to program functions.

Maintain contacts with counterparts within the NCI-designated cancer centers to assure the best practices are implemented within the CU Cancer Center; attends meetings and conferences with external colleagues as appropriate.

Works with OnCore® leadership as needed to identify new practices and features to improve consistency within OnCore® for all investigative groups within the CU Cancer Center.

Personnel Management and Training:

Responsible for hiring, evaluation and discipline of DSMC auditors while ensuring day-to-day activities of DSMC are appropriately executed, including:

All audit activities including investigator-initiated trial audits, ‘for cause audits, external audit preps, National Clinical Trials Network (NCTN) audits, regulatory audits, and pharmacy audits.

Collection and analysis of audit trends for training and education of clinical research staff.

Training and supervision of DSMC audit team.

Provides recommendations, guidance, and training to prospective internal clients (faculty and staff) and Cancer Center clinical leadership on appropriate protocol oversight and DSMC policies and procedures.

Work Location:

Hybrid

Why Join Us:

Position #: 699241 – Requisition #35075

Job Summary:

Examples of Work Performed:

Program Management and Administration:

Oversees all data and safety monitoring programs and activities required to maintain UCCCs standing as a National Cancer Institute (NCI)-designated Comprehensive Cancer Center.

Manages unit operations to assure adherence to all research standards set forth by the NCI, FDA, OHRP and institution.

Reviews all protocols conducted through the CU Cancer Center, as a component of the PRMS submission/review process to ensure trial oversight requirements are properly categorized and that all investigator-initiated trials have adequate safety oversight in relationship to the trials risk.

Coordination and organization of all preparatory and post-audit activities including approving audit reports and escalating unacceptable findings as needed.

Maintains DSMC-relevant data within the OnCore® clinical trial management system.

Prepares and facilitates all DSMC meetings.

Facilitates the review of all SAEs, UAPs and DSM Progress Reports received by the DSMC and manages the documentation for review by the NCI as required.

Responsible for strategic planning for the effective deployment of program oversight mechanisms and manages the goals and output of all operational components.

Manages DSM budget to ensure effective allocation of funds and unit services.

Leads DSM administrative efforts to manage unit goals and outcomes.

Process Improvement, Guidance Development, and Collaboration :

Leads compliance operations by developing, managing, and supervising implemented processes and procedures employed by UCCC member investigators and staff.

Interprets policies, standards, and regulations, and evaluates potentially critical problems not covered by policies, standards, and regulations.

Recommend strategies and draft policies and processes to support necessary oversight activities; work with the DSMC Chair, DSM Committee, Quality and Compliance Program Director, Cancer Center clinical and administrative leadership to develop consensus and support for policies and processes across the various constituencies within the Cancer Center.

Ensures continuous process improvement and compliance. Subject matter expert to internal and external audiences regarding policies, procedures, and activities relevant to program functions.

Maintain contacts with counterparts within the NCI-designated cancer centers to assure the best practices are implemented within the CU Cancer Center; attends meetings and conferences with external colleagues as appropriate.

Works with OnCore® leadership as needed to identify new practices and features to improve consistency within OnCore® for all investigative groups within the CU Cancer Center.

Personnel Management and Training:

Responsible for hiring, evaluation and discipline of DSMC auditors while ensuring day-to-day activities of DSMC are appropriately executed, including:

All audit activities including investigator-initiated trial audits, ‘for cause audits, external audit preps, National Clinical Trials Network (NCTN) audits, regulatory audits, and pharmacy audits.

Collection and analysis of audit trends for training and education of clinical research staff.

Training and supervision of DSMC audit team.

Provides recommendations, guidance, and training to prospective internal clients (faculty and staff) and Cancer Center clinical leadership on appropriate protocol oversight and DSMC policies and procedures.

Work Location:

Hybrid

Why Join Us:

Job Summary:

Examples of Work Performed:

Program Management and Administration:

Oversees all data and safety monitoring programs and activities required to maintain UCCCs standing as a National Cancer Institute (NCI)-designated Comprehensive Cancer Center.

Manages unit operations to assure adherence to all research standards set forth by the NCI, FDA, OHRP and institution.

Reviews all protocols conducted through the CU Cancer Center, as a component of the PRMS submission/review process to ensure trial oversight requirements are properly categorized and that all investigator-initiated trials have adequate safety oversight in relationship to the trials risk.

Coordination and organization of all preparatory and post-audit activities including approving audit reports and escalating unacceptable findings as needed.

Maintains DSMC-relevant data within the OnCore® clinical trial management system.

Prepares and facilitates all DSMC meetings.

Facilitates the review of all SAEs, UAPs and DSM Progress Reports received by the DSMC and manages the documentation for review by the NCI as required.

Responsible for strategic planning for the effective deployment of program oversight mechanisms and manages the goals and output of all operational components.

Manages DSM budget to ensure effective allocation of funds and unit services.

Leads DSM administrative efforts to manage unit goals and outcomes.

Process Improvement, Guidance Development, and Collaboration :

Leads compliance operations by developing, managing, and supervising implemented processes and procedures employed by UCCC member investigators and staff.

Interprets policies, standards, and regulations, and evaluates potentially critical problems not covered by policies, standards, and regulations.

Recommend strategies and draft policies and processes to support necessary oversight activities; work with the DSMC Chair, DSM Committee, Quality and Compliance Program Director, Cancer Center clinical and administrative leadership to develop consensus and support for policies and processes across the various constituencies within the Cancer Center.

Ensures continuous process improvement and compliance. Subject matter expert to internal and external audiences regarding policies, procedures, and activities relevant to program functions.

Maintain contacts with counterparts within the NCI-designated cancer centers to assure the best practices are implemented within the CU Cancer Center; attends meetings and conferences with external colleagues as appropriate.

Works with OnCore® leadership as needed to identify new practices and features to improve consistency within OnCore® for all investigative groups within the CU Cancer Center.

Personnel Management and Training:

Responsible for hiring, evaluation and discipline of DSMC auditors while ensuring day-to-day activities of DSMC are appropriately executed, including:

All audit activities including investigator-initiated trial audits, ‘for cause audits, external audit preps, National Clinical Trials Network (NCTN) audits, regulatory audits, and pharmacy audits.

Collection and analysis of audit trends for training and education of clinical research staff.

Training and supervision of DSMC audit team.

Provides recommendations, guidance, and training to prospective internal clients (faculty and staff) and Cancer Center clinical leadership on appropriate protocol oversight and DSMC policies and procedures.

Work Location:

Hybrid

Why Join Us:

Why work for the University?

Medical: Multiple plan options

Dental: Multiple plan options

Additional Insurance: Disability, Life, Vision

Retirement 401(a) Plan: Employer contributes 10% of your gross pay

Paid Time Off: Accruals over the year

Vacation Days: 22/year (maximum accrual 352 hours)

Sick Days: 15/year (unlimited maximum accrual)

Holiday Days: 10/year

Tuition Benefit: Employees have access to this benefit on all CU campuses

ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage (https://apptrkr.com/getredirect.php?id=5706553&targetURL=https://advantage.cu.edu/) .

Diversity and Equity:

Qualifications:

Minimum Qualifications:

A bachelors degree in public health, public administration, public policy, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, communications, or a directly related field from an accredited institution.

Five (5) years of clinical research auditing and/or clinical research regulatory experience

Four (4) years of clinical research experience (can be included in above)

Two (2) years of supervisory experience (can be included in above). Additional education can substitute for supervisory experience.

Preferred Qualifications

Seven (7) or more years of clinical research experience

Experience with oncology research clinical research, including investigator-initiated, NCTN and industry-sponsored clinical trials.

Experience conducting various phases of clinical trials

Experience with device clinical trials

Experience with human subject research not involving new drugs or devices, such as specimen banks or non-drug interventions

Experience with University of Colorado Cancer Center CCTO, HCTU and other Cancer Center clinical trials units Policy and Procedures in relation to conducting multiple clinical trials

Experience with OnCore® clinical trial management system

Experience developing SOPs

Knowledge, Skills and Abilities:

Ability to work independently

Superior organization skills

Strategic leadership skills

Excellent interpersonal and communication skills (oral and written)

Ability to manage competing priorities and deadlines

Proactively assess potential problems and provide timely solutions

Proficiency with OnCore® clinical trials management system, Windows and MS Office

Applicants must meet minimum qualifications at the time of application.

How to Apply:

Screening of Applications Begins:

October 10, 2024.

Anticipated Pay Range:

or hiring range

or hiring range

ADA Statement:

ADA Statement:

Background Check Statement:

Vaccination Statement:

Job Category

Primary Location

Schedule

Posting Date

Unposting Date

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The DSMC Manager is responsible for working closely with the DSM Committee Chair and the Quality and Compliance Program Director to ensure compliance with the National Cancer Institute (NCI) approved Institutional Data & Safety Monitoring (DSM) Plan and manage this critical function of the Cancer Center. The individual in the role will be expected to oversee and execute all activities associated with auditing, protocol reviews for inclusion of appropriate data and safety monitoring language, coordination of quarterly DSMC meeting, and safety reporting. The DSMC Manager will contribute to the development and implementation of new policies and processes to ensure DSMC is able to meet the changing environment driven by growth in the clinical research portfolio, changes in institutional, federal and/or NCI policies, and growth in the clinical entities that comprise the Cancer Centers membership. This position will directly oversee the DSMC Auditors. 50% 20% 30%

– this role is eligible for a hybrid schedule

The https://apptrkr.com/getredirect.php?id=5706553&targetURL=Data Safety and Monitoring Manager

The DSMC Manager is responsible for working closely with the DSM Committee Chair and the Quality and Compliance Program Director to ensure compliance with the National Cancer Institute (NCI) approved Institutional Data & Safety Monitoring (DSM) Plan and manage this critical function of the Cancer Center. The individual in the role will be expected to oversee and execute all activities associated with auditing, protocol reviews for inclusion of appropriate data and safety monitoring language, coordination of quarterly DSMC meeting, and safety reporting. The DSMC Manager will contribute to the development and implementation of new policies and processes to ensure DSMC is able to meet the changing environment driven by growth in the clinical research portfolio, changes in institutional, federal and/or NCI policies, and growth in the clinical entities that comprise the Cancer Centers membership. This position will directly oversee the DSMC Auditors. 50% 20% 30%

– this role is eligible for a hybrid schedule

The https://apptrkr.com/getredirect.php?id=5706553&targetURL=699241 – Requisition #35075

The DSMC Manager is responsible for working closely with the DSM Committee Chair and the Quality and Compliance Program Director to ensure compliance with the National Cancer Institute (NCI) approved Institutional Data & Safety Monitoring (DSM) Plan and manage this critical function of the Cancer Center. The individual in the role will be expected to oversee and execute all activities associated with auditing, protocol reviews for inclusion of appropriate data and safety monitoring language, coordination of quarterly DSMC meeting, and safety reporting. The DSMC Manager will contribute to the development and implementation of new policies and processes to ensure DSMC is able to meet the changing environment driven by growth in the clinical research portfolio, changes in institutional, federal and/or NCI policies, and growth in the clinical entities that comprise the Cancer Centers membership. This position will directly oversee the DSMC Auditors. 50% 20% 30%

– this role is eligible for a hybrid schedule

The University of Colorado Cancer Center (https://apptrkr.com/getredirect.php?id=5706553&targetURL=file:///C:/Users/gallk/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/9ETJDC2O/University of Colorado Cancer Center) stands at the forefront of cancer research and patient care in Colorado. As the states only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control. Our guiding vision is clear: “prevent and conquer cancer. Together.” At the heart of our mission is the work to “unite our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education.” Our more than 300 members, made up of renowned physicians and researchers, conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Crucial to this work is the nearly 300 staff members who help expand the reach of the CU Cancer Center. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive cancers who have struggled to find treatment options elsewhere. We have AMAZING benefits and offerexceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including: To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness (https://apptrkr.com/getredirect.php?id=5706553&targetURL=https://www.cu.edu/employee-services/benefits-wellness)

At the University of Colorado Cancer Center (CU Cancer Center), we deem diversity in thought, perspective, lived experiences, and backgrounds to be essential for understanding and providing world-class health and cancer care to our diverse patient populations. We are, therefore, committed to the intentional development of a diverse, equitable, inclusive, and respectful academic community and workplace. We actively encourage individuals of all races, religions, national origins, genders, gender expressions, sexual orientations, ages, as well as veterans and individuals with disabilities to apply for positions at the CU Cancer Center. If you are an applicant with a disability, the University will provide reasonable accommodations throughout the employment application process. Please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu (https://apptrkr.com/getredirect.php?id=5706553&targetURL=hr.adacoordinator@cuanschutz.edu) to request an accommodation in accordance with the Americans with Disability Act.

For full consideration, please submit the following document(s): 1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position 2. Curriculum vitae / Resume 3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address Questions should be directed to: Jessica.dry@cuanschutz.edu (https://apptrkr.com/getredirect.php?id=5706553&targetURL=Jessica.dry@cuanschutz.edu)

Applications will be accepted until finalists are identified, but preference will be given to complete applications received byThose who do not apply by this date may or may not be considered.

The starting salary range () for this position has been established as $74,995-$95,393 The above salary range () represents the Universitys good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level. Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line. Total Compensation Calculator: http://www.cu.edu/node/153125 (https://apptrkr.com/getredirect.php?id=5706553&targetURL=http://www.cu.edu/node/153125) The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at https://apptrkr.com/getredirect.php?id=5706553&targetURL= The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu (https://apptrkr.com/getredirect.php?id=5706553&targetURL=hr.adacoordinator@cuanschutz.edu) ​.

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (https://apptrkr.com/getredirect.php?id=5706553&targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program (https://apptrkr.com/getredirect.php?id=5706553&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) .

Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Hybrid Department: U0001 — Anschutz Med Campus or Denver – 20066 – SOM-U of Colo Cancer Center : Full-time : Oct 3, 2024 : Ongoing Posting Contact Name: Jessica Dry Posting Contact Email: Jessica.dry@cuanschutz.edu (https://apptrkr.com/getredirect.php?id=5706553&targetURL=Jessica.dry@cuanschutz.edu) Position Number: 00699241jeid-9a556f6cb3cfa641aafc0e247ad70480

The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.