Project Manager A/B

Description

Job Responsibilities

The Project Manager will provide project management and regulatory support and expertise associated with clinical trials for the Penn Department of Medicine’s Clinical Trials Unit.

The person will work closely with the Director of Clinical Research Operations to support a diverse group of investigators and coordinators, involving work on a wide spectrum of clinical trials ranging from phase I-IV, investigator / industry-initiated, different disease states and varying complexities.

Involvement will range from consulting to serving as the project manager for a study having primary responsibility with respect to execution and operational planning of the studies and accountability for results.

The Project Manager will oversee the delivery of patient care as defined in the study protocols.The Project Manager will manage / supervise the study teams assuring that each clinical trial meets expectations and that they are conducted in accordance with the specific clinical protocol as approved by the Sponsor, study team and in accordance with all regulatory organizations.

S / he will play a key role in study start-up, intake & feasibility for many studies.

The Project Manager will provide oversight and support for each study team, lead team meetings, drive study timelines, recruitment, and overall performance.

S / he will generate study specific plans and documents, provide input and management of study budgets, and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.

S / he will lead problem solving and resolution efforts, and review study status and monitor reports to identify and address possible issues.

S / he will provide leadership and guidance to research personnel in their day-to-day operational activities. S / he will perform regulatory duties including regulatory oversight, regulatory submissions, and compliance checks.

S / he will participate in documentation of best practices and SOPs. S / he will participate in the Department of Medicine research initiatives including the Training Program and Activation of Clinical Research at Penn Affiliate Hospitals.

DUTIES :

Project Manager A : Supervise, manage and train study teams, including developing and driving study timelines and strategies, and directly manage 1-2 staff.

PM-A : With supervision, manage research studies conducted through the DOM Clinical Trials Unit in accordance with Good Clinical Practice guidelines and all applicable regulatory guidelines.

PM-A : Conduct study related visits and procedures, including recruitment, when needed to meet the needs of DOM CTU Research Projects.

PM-A : With supervision, develop, create and review regulatory submissions, including protocols, consents, annual reports, unanticipated problems, etc.

and address regulatory reviewer inquiries. Provide assistance with IND / IDE / CTA exemption determinations.

PM-A : Manage study budgets and assure payments are received and paid out in a timely manner.

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

Develop source docs, training slides, manual of procedures, CRFs and SOPs related to each study.

Lead internal and external meetings and ensure unresolved issues are followed to resolution.

Perform other duties as needed.

Project Manager B : Supervise, manage and train study teams, including developing and driving study timelines and strategies, and directly manage 2-4 staff.

PM -B : With directly with primary investigator to manage research studies conducted through the DOM Clinical Trials Unit in accordance with Good Clinical Practice guidelines and all applicable regulatory guidelines.

PM-B : Develop, create and review regulatory submissions, including protocols, consents, annual reports, unanticipated problems, etc.

and address regulatory reviewer inquiries. Provide assistance with IND / IDE / CTA exemption determinations.

PM-B : Develop, negotiate and manage study budgets and assure payments are received and paid out in a timely manner.

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

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.

Develop source docs, training slides, manual of procedures, CRFs and SOPs related to each study.

Lead internal and external meetings and ensure unresolved issues are followed to resolution.

Perform other duties as needed.

Contingent Upon Funding.

Qualifications

Manager Research Project A

Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required.

Manager Research Project B

Master of Science and 3 to 5 years of experience or equivalent combination of education and experience is required.

Preferred

Strong planning and organizational capabilities along with attention to detail, excellent follow through and problem-solving skills necessary.

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.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$51,824.00 - $81,441.00 Annual Rate

Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.

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.

University Benefits

Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare.

You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.

Tuition : Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn.

Your dependent children are also eligible for tuition assistance at other institutions.

Retirement : Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis.

Choose from a wide variety of investment options through TIAA and Vanguard.

Time Away from Work : Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family whatever your personal needs may be.

Long-Term Care Insurance : In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility.

If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements.

Eligible family members must always provide proof of good health and are subject to underwriting.

Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life.

That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.

Professional and Personal Development : Penn provides an array of resources to help you advance yourself personally and professionally.

University Resources : As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities.

Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples.

As a member of the Penn community, you’re right in the middle of the excitement and you and your family can enjoy many of these activities for free.

Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff.

Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff.

You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.

Flexible Work Hours : Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments.

These approaches involve use of non-traditional work hours, locations, and / or job structures.

Penn Home Ownership Services : Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.

Adoption Assistance : Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.