IND/IDE Office Program Manager - 34555 University Staff

Description

University of Colorado Anschutz Medical Campus

Department: Clinical Research and Operations Services

Job Title: IND/IDE Office Program Manager

Position #: 797456 – Requisition #: 34555

Job Summary:

Key Responsibilities:

Program Management: - 70%

• Manages and continually improves processes related to initial intake and assessments as required under the IND/IDE program for projects requiring submissions to the FDA.

• Monitors tools and processes for tracking performance metrics and prepares data for leadership.

• Works in collaboration with leadership and continuous improvement (CI) experts to develop CI plans and utilize CI tools that will support organizational goals.

• Cross-functionally manages project elements and meetings, to support and improve the operations of the IND/IDE program.

• In collaboration with the IND/IDE Program's Medical Directors, completes protocol risk and recruitment feasibility assessments, facilitates administrative budget reviews and prepares competing studies reports.

• Assists with financial tracking of IND/IDE office team expenses.

• Facilitates communication and acts as primary point of contact with study teams, and other internal and external stakeholders as needed.

• Ensures timely communication and appropriate escalation of unresolved obstacles.

Pharmacovigilance Support – 30%

Assists IND/IDE program's Pharmacovigilance Specialist in:

• Reviews of adverse safety events and protocol deviations, missing data and data quality controls, in close collaboration with the Medical Director and Principal Investigator

• Monitors e-mail for safety reports and facilitates a timely review by the Medical Director, coordinate with the FDA as applicable and ensure that safety reports with appropriate documentation are submitted to the applicable regulatory agencies in a timely fashion.

• Provides safety reports and other regulatory documents as needed to the Safety Monitoring Committee prior to each meeting. Coordinate with the appropriate Safety Monitoring Committee to ensure that all applicable safety reports are reviewed in accordance with their charter.

• Coordinates with the regulatory team to ensure that consistent information is submitted to all relevant stakeholders in the review processes with oversight of safety data.

• Ensures that Trial Master Files are compliant with all applicable federal guidance.

• Participates in on-going process improvement initiatives.

• Other relevant tasks as delegated by the supervisor or leadership

Work Location:

Hybrid

Why Join Us:

Position #: 797456 – Requisition #: 34555

Job Summary:

Key Responsibilities:

Program Management: - 70%

• Manages and continually improves processes related to initial intake and assessments as required under the IND/IDE program for projects requiring submissions to the FDA.

• Monitors tools and processes for tracking performance metrics and prepares data for leadership.

• Works in collaboration with leadership and continuous improvement (CI) experts to develop CI plans and utilize CI tools that will support organizational goals.

• Cross-functionally manages project elements and meetings, to support and improve the operations of the IND/IDE program.

• In collaboration with the IND/IDE Program's Medical Directors, completes protocol risk and recruitment feasibility assessments, facilitates administrative budget reviews and prepares competing studies reports.

• Assists with financial tracking of IND/IDE office team expenses.

• Facilitates communication and acts as primary point of contact with study teams, and other internal and external stakeholders as needed.

• Ensures timely communication and appropriate escalation of unresolved obstacles.

Pharmacovigilance Support – 30%

Assists IND/IDE program's Pharmacovigilance Specialist in:

• Reviews of adverse safety events and protocol deviations, missing data and data quality controls, in close collaboration with the Medical Director and Principal Investigator

• Monitors e-mail for safety reports and facilitates a timely review by the Medical Director, coordinate with the FDA as applicable and ensure that safety reports with appropriate documentation are submitted to the applicable regulatory agencies in a timely fashion.

• Provides safety reports and other regulatory documents as needed to the Safety Monitoring Committee prior to each meeting. Coordinate with the appropriate Safety Monitoring Committee to ensure that all applicable safety reports are reviewed in accordance with their charter.

• Coordinates with the regulatory team to ensure that consistent information is submitted to all relevant stakeholders in the review processes with oversight of safety data.

• Ensures that Trial Master Files are compliant with all applicable federal guidance.

• Participates in on-going process improvement initiatives.

• Other relevant tasks as delegated by the supervisor or leadership

Work Location:

Hybrid

Why Join Us:

Job Summary:

Key Responsibilities:

Program Management: - 70%

• Manages and continually improves processes related to initial intake and assessments as required under the IND/IDE program for projects requiring submissions to the FDA.

• Monitors tools and processes for tracking performance metrics and prepares data for leadership.

• Works in collaboration with leadership and continuous improvement (CI) experts to develop CI plans and utilize CI tools that will support organizational goals.

• Cross-functionally manages project elements and meetings, to support and improve the operations of the IND/IDE program.

• In collaboration with the IND/IDE Program's Medical Directors, completes protocol risk and recruitment feasibility assessments, facilitates administrative budget reviews and prepares competing studies reports.

• Assists with financial tracking of IND/IDE office team expenses.

• Facilitates communication and acts as primary point of contact with study teams, and other internal and external stakeholders as needed.

• Ensures timely communication and appropriate escalation of unresolved obstacles.

Pharmacovigilance Support – 30%

Assists IND/IDE program's Pharmacovigilance Specialist in:

• Reviews of adverse safety events and protocol deviations, missing data and data quality controls, in close collaboration with the Medical Director and Principal Investigator

• Monitors e-mail for safety reports and facilitates a timely review by the Medical Director, coordinate with the FDA as applicable and ensure that safety reports with appropriate documentation are submitted to the applicable regulatory agencies in a timely fashion.

• Provides safety reports and other regulatory documents as needed to the Safety Monitoring Committee prior to each meeting. Coordinate with the appropriate Safety Monitoring Committee to ensure that all applicable safety reports are reviewed in accordance with their charter.

• Coordinates with the regulatory team to ensure that consistent information is submitted to all relevant stakeholders in the review processes with oversight of safety data.

• Ensures that Trial Master Files are compliant with all applicable federal guidance.

• Participates in on-going process improvement initiatives.

• Other relevant tasks as delegated by the supervisor or leadership

Work Location:

Hybrid

Why Join Us:

Work Location:

Hybrid

Why Join Us:

Diversity and Equity:

Qualifications:

Minimum Qualifications:

• A bachelor's degree in public health, physical sciences, nursing, healthcare, or a directly related field from an accredited institution.

• Minimum of 5 years of professional-level experience in clinical trial operations and/or management with experience preparing documentation related to safety event processing and reporting to institutional and/or federal entities

• Professional clinical research experience in an academic medical center

• Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

Preferred Qualifications:

• Advanced degree, (MA, MS, RN) or the equivalent combination of education, training and experience from which comparable skills can be acquired, preferably in life sciences or health-related field

• Medical or Scientific background and understanding of adjudication of adverse events and other reportable safety events

• Experience in safety-related submissions to regulatory agencies (e.g. the Food and Drug Administration)

Knowledge, Skills and Abilities:

• Ability to communicate effectively, both in writing and orally.

• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.

• Outstanding customer service skills.

• Demonstrated commitment and leadership ability to advance diversity and inclusion.

Additional Competencies:

• Excellent interpersonal skills and ability to develop strong relationships with stakeholders

• Exceptional communication and interpersonal skills, both oral and written

• Strong critical thinking and problem-solving skills

• Excellent multi-tasking and organizational skills, as well as the ability to make complex decisions in a fast-paced environment

• Ability to learn quickly and understand new technical concepts and processes

• Flexible and able to adapt to program growth and evolving responsibilities

• Self-motivated and able to work in a team environment

• Able to work well under pressure, especially when assisting involved stakeholders

• Proficiency in Microsoft Suite

• A strong working knowledge of Good Clinical Practices (GCP), U.S. Food and Drug Administration (FDA) rules and regulations in relation to clinical trials, National Institutes of Health (NIH) guidelines, International Council for Harmonisation (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) regulations in relation to clinical trials, and other universally accepted practices and procedures within clinician trial management.

• Strong financial acumen

How to Apply:

Screening of Applications Begins:

August 28, 2024.

Anticipated Pay Range:

or hiring range $71,995 - $91,577.

or hiring range

ADA Statement:

Background Check Statement:

Vaccination Statement:

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The IND/IDE Office Program Manager within the Office of Clinical Research Operations and Services is the first contact point for clinical researchers requiring assistance with any type of submission to the FDA. This position is primarily responsible for managing processes related to the initiation of projects that require submission to FDA, and also with assisting the office's pharmacovigilance specialist and site investigators with proper documentation of Serious Adverse Events that occurred in studies with locally held INDs/IDEs, or compassionate use treatments. The Program Manager will build and maintain strong and impactful relationships, while working cross-functionally and collaboratively to manage the IND/IDE program.

– this role is eligible for a hybrid schedule of 2 days per month on campus and as needed for in-person meetings.

The IND/IDE Office was implemented to support FDA-regulated high-quality human research projects throughout their regulatory lifecycle. This office offers regulatory advice and hands on assistance at every stage of the research process, from planning and design to implementation, submission and reporting to FDA. Our processes ensure that our investigator-initiated studies under FDA oversight are feasible, can be completed successfully, and are carried out in compliance with all applicable regulations and guidelines from study initiation and recruitment to study closure. The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://apptrkr.com/get_redirect.php?id=5615326&targetURL=IND/IDE Office Program Manager

The IND/IDE Office Program Manager within the Office of Clinical Research Operations and Services is the first contact point for clinical researchers requiring assistance with any type of submission to the FDA. This position is primarily responsible for managing processes related to the initiation of projects that require submission to FDA, and also with assisting the office's pharmacovigilance specialist and site investigators with proper documentation of Serious Adverse Events that occurred in studies with locally held INDs/IDEs, or compassionate use treatments. The Program Manager will build and maintain strong and impactful relationships, while working cross-functionally and collaboratively to manage the IND/IDE program.

– this role is eligible for a hybrid schedule of 2 days per month on campus and as needed for in-person meetings.

The IND/IDE Office was implemented to support FDA-regulated high-quality human research projects throughout their regulatory lifecycle. This office offers regulatory advice and hands on assistance at every stage of the research process, from planning and design to implementation, submission and reporting to FDA. Our processes ensure that our investigator-initiated studies under FDA oversight are feasible, can be completed successfully, and are carried out in compliance with all applicable regulations and guidelines from study initiation and recruitment to study closure. The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://apptrkr.com/get_redirect.php?id=5615326&targetURL=797456 – Requisition #: 34555

The IND/IDE Office Program Manager within the Office of Clinical Research Operations and Services is the first contact point for clinical researchers requiring assistance with any type of submission to the FDA. This position is primarily responsible for managing processes related to the initiation of projects that require submission to FDA, and also with assisting the office's pharmacovigilance specialist and site investigators with proper documentation of Serious Adverse Events that occurred in studies with locally held INDs/IDEs, or compassionate use treatments. The Program Manager will build and maintain strong and impactful relationships, while working cross-functionally and collaboratively to manage the IND/IDE program.

– this role is eligible for a hybrid schedule of 2 days per month on campus and as needed for in-person meetings.

The IND/IDE Office was implemented to support FDA-regulated high-quality human research projects throughout their regulatory lifecycle. This office offers regulatory advice and hands on assistance at every stage of the research process, from planning and design to implementation, submission and reporting to FDA. Our processes ensure that our investigator-initiated studies under FDA oversight are feasible, can be completed successfully, and are carried out in compliance with all applicable regulations and guidelines from study initiation and recruitment to study closure. The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://apptrkr.com/get_redirect.php?id=5615326&targetURL= – this role is eligible for a hybrid schedule of 2 days per month on campus and as needed for in-person meetings.

The IND/IDE Office was implemented to support FDA-regulated high-quality human research projects throughout their regulatory lifecycle. This office offers regulatory advice and hands on assistance at every stage of the research process, from planning and design to implementation, submission and reporting to FDA. Our processes ensure that our investigator-initiated studies under FDA oversight are feasible, can be completed successfully, and are carried out in compliance with all applicable regulations and guidelines from study initiation and recruitment to study closure. The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness (https://apptrkr.com/get_redirect.php?id=5615326&targetURL=https://www.cu.edu/employee-services/benefits-wellness) .

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Minimum Qualifications: include specific fields(s) of study

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: Jen Su, Jennifer.Su@ucdenver.edu (https://apptrkr.com/get_redirect.php?id=5615326&targetURL=Jennifer.Su@ucdenver.edu)

Immediately and continues until position is posted. For best consideration, apply by

The starting salary range () for this position has been established as The above salary range () represents the University's 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/get_redirect.php?id=5615326&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 hr.adacoordinator@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5615326&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/get_redirect.php?id=5615326&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/get_redirect.php?id=5615326&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 - 21976 - ADM AVC Clinical Res Operation : Full-time : Aug 14, 2024 : Ongoing Posting Contact Name: Jen Su Posting Contact Email: Jennifer.Su@ucdenver.edu (https://apptrkr.com/get_redirect.php?id=5615326&targetURL=Jennifer.Su@ucdenver.edu) Position Number: 00797456jeid-2f117a278204384bab04c3a1508ebd63

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.