Clinical Research Program Manager

Job description



Clinical Research Program Manager

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Posted Job Title
Clinical Research Program Manager

Job Profile Title
Manager Research Project B

Job Description Summary
The Program Manager will provide staff oversight, project management, leadership and expertise associated with clinical trials for the Penn Infectious Diseases Clinical Research Unit consisting of projects in HIV, COVID-19, and other infectious diseases. The position will oversee the daily operations of the unit working closely with the Investigators to support a clinical research portfolio of varying complexity ranging from phase I-IV and including investigator/industry-initiated studies. The Program Manager will be responsible for execution and operational planning of the studies and accountability for results. The Program Manager will oversee the delivery of patient care as defined in the study protocols. The Program Manager will manage/supervise the study staff (10 to 15 staff) assuring that each clinical trial meets expectations and is conducted in accordance with the specific clinical protocol as approved by the Sponsor, study team and in accordance with all regulatory organizations. They will play a key role in study start-up, intake & feasibility for many studies. They will be responsible to develop and maintain best practices and procedures. They will communicate issues or problems to the Investigators and follow-up until issues are resolved in an acceptable manner.

They will oversee expenditures and income, negotiate agreements with service providers, and interact with the business administration to ensure income is received and expenditures are paid. The position will also include participation in national organization meetings, as well as University department meetings and committees. The staff member will maintain skill levels through educational opportunities, sponsor trainings, attendance at conferences and communication with other providers.

Job Description

Manager B: The Program Manager will provide staff oversight, project management, leadership and expertise associated with clinical trials for the Penn Infectious Diseases Clinical Research Unit consisting of projects in HIV, COVID-19, and other infectious diseases. The position will oversee the daily operations of the unit working closely with the Investigators to support a clinical research portfolio of varying complexity ranging from phase I-IV and including investigator/industry-initiated studies. The Program Manager will be responsible for execution and operational planning of the studies and accountability for results. The Program Manager will oversee the delivery of patient care as defined in the study protocols. The Program Manager will manage/supervise the study staff (10 to 15 staff) assuring that each clinical trial meets expectations and is conducted in accordance with the specific clinical protocol as approved by the Sponsor, study team and in accordance with all regulatory organizations. They will play a key role in study start-up, intake & feasibility for many studies. They will be responsible to develop and maintain best practices and procedures. They will communicate issues or problems to the Investigators and follow-up until issues are resolved in an acceptable manner.

They will oversee expenditures and income, negotiate agreements with service providers, and interact with the business administration to ensure income is received and expenditures are paid. The position will also include participation in national organization meetings, as well as University department meetings and committees. The staff member will maintain skill levels through educational opportunities, sponsor trainings, attendance at conferences and communication with other providers.

Manager C: Level C manager is expected to perform the duties above with more limited supervision from the Director. In addition, will be able to oversee more staff and higher level staff (including the lab manager and data manager) and will be able to implement and oversee more projects and more complex projects. Independently run the research program, resolving problems and setting strategic goals with input from supervisor as required. Management of the full Program and will need to use more independent judgment.

Duties:

1) Supervision of Clinical Research Unit staff to ensure patient safety, protocol adherence, and achievement of project goals.

2) Project manage research studies conducted through the ACTU Clinical Research Unit in accordance with Good Clinical Practice guidelines and all applicable regulatory guidelines.

3) Communicate with and report to Investigators as part of unit management, help to drive strategic mission of unit and project timelines, and lead team meetings ensuring issues are resolved.

4) Lead study intake and drive study start-up for trials including feasibility assessments, liaising with sponsors, vendors, CROs & PI teams, and completing start-up regulatory documents and submissions.

5) Develop, create and review regulatory submission and study documents/tools, including protocols, consents, annual reports, source docs, training slides, MOPs, CRFs, SOPs. Provide assistance with IND/IDE/CTA exemption determinations.

6) Work with Business Administrators to create and manage budgets, charges and payments

7) Oversee data and sample management, including compliance checks and helping teams prepare for audits.

8) Develop operational processes and best practices to help guide and provide oversight to research personnel, including continuing educational opportunities for staff.

9) Perform other duties as needed.

Strong planning and organizational capabilities along with attention to detail, excellent follow through and problem solving skills necessary. Strong staff management skills required. Must be effective in setting and meeting personal short and long-term goals to complete assignments, with multiple project tasks ongoing simultaneously. Successful candidates will have the ability to anticipate problems relating to projects and to develop and implement solutions. Flexibility and the drive to meet project deadlines required. Knowledge of regulatory processes required. Excellent written and verbal skills required. Position contingent upon funding.

Manager B: A Bachelor's Degree and 5 - 7 years of related experience or equivalent combination of education and experience in working on clinical trials required. Master degree with 3 - 5 years is preferred.

Manager C: A Master's Degree and 5 - 7 years of related experience or equivalent combination of education and experience in working on clinical trials required.

*Position contingent upon funding.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$59,703.00 - $113,435.00

Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.


To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/HUP/Clinical-Research-Program-Manager_JR00027898





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Job No:
Posted: 1/15/2021
Application Due: 1/15/2033
Work Type: Full Time
Salary: