Project Manager B: Protocol Development, Clinical Statistics and Data Analyses

Project Manager B: Protocol Development, Clinical Statistics and Data Analyses

Manager Research Project B

Job Responsibilities Investigator Initiated Protocol/Study Specific

· Collaborate with Cardiac Surgeon/PIs to define study objectives and requirements on investigator initiated clinical trials (IDE and IND)

· Design and draft detailed investigator initiated protocols (including eligibility, screening, study assessments) that comply with regulatory standards

· Design and draft informed patient consent forms specific to each investigator initiated protocol

· Liaisons with statisticians, Surgeon PIs, co-investigators, clinical trials support staff on all trials

· Expand non-scientific sections of protocols with minimal oversight

· Review and revise investigator initiated protocols based on feedback from federal, state and local regulatory authorities. Prepare annual reports for regulatory authorities.

· Provide ongoing training and study start-up for investigator initiated studies

· Develop study specific case report forms (CRF) with statistical input. Standardize data type specifications to align with Electronic Data Capture (EDC) requirements and clinical trial objectives.

· Develop on-line clinical trial management data bases to monitor and analyze clinical trial study requirements and data analyses

Study Start-Up for Investigator Initiated Studies

· Independently prepare and negotiate clinical trials budgets with external sponsors

· Conduct study qualification visits for multi-site studies

· Conduct study initiation visits for all sites (including UPHS facilities)

· Develop detailed data transfer specifications for acquiring external data transfer from participating sites

Study Monitoring/Compliance for Investigator Initiated Studies

· Responsible for ensuring timely and accurate completion of Serious Adverse Events (SAEs) and Adverse Events (AEs) at participating sites (UPHS and external locations)

· Monitor participating sites for protocol compliance and deviations with reports to regulatory authorities as required

· Issue and resolve queries from various data sources (medical coding, medical history, adverse events, procedures and medical devices)

Statistical and Study Related Analyses

· Review of emerging clinical data and trends in cardiac surgery

· Design complex surgical outcomes databases

· Analyze complex surgical outcomes databases

· Integrate database systems with statistics programs using SAS, Stata and other tools

· Perform complex programming using large databases of more than 1 million records and nationwide hospital data sets for use in health services research and quality analyses. Create analytic files. Develop the standard statistical algorithms for hypothesis testing

· Supervise students, Penn Surgery residents, fellows, lab members and mentor them in design of data base systems.

NIH Grant and Manuscripts – Technical Writing

· Prepare sections of NIH grant application and manuscripts specific to Significance, Statistical Methods, Analyses, Findings, Conclusions, References in collaboration with the faculty PI

Qualifications

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

• Experience with clinical research protocols essential

• Familiarity with regulatory processes (GCP) for clinical protocols and informed consent development

This position is contingent upon grant funding

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$66,000.00 - $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, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements Background checks may be 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.