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

University of Pennsylvania; Philadelphia (Philadelphia County); On-site; USD 66,000 - 81,441; Full time

Benefits offered by this job

Healthcare benefits

Tuition assistance

Generous retirement plans

Substantial time off

Professional development opportunities

Job summary

A prestigious university in Philadelphia is looking for a Project Manager B to oversee clinical protocols, manage day-to-day project operations, and collaborate with researchers. The role involves developing study protocols, statistical analyses, and preparing grant applications. Candidates should have a Master's degree coupled with 3 to 5 years of relevant experience in clinical research. The position offers a salary range of $66,000 to $81,441 annually and exceptional employee benefits including healthcare and tuition assistance.

Qualifications

• Master of Science and 3 to 5 years of experience or an 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.

Responsibilities

• Collaborate with Cardiac Surgeon/PIs to define study objectives.
• Design and draft detailed protocols compliant with standards.
• Monitor participating sites for protocol compliance.
• Analyze complex surgical outcomes databases.
• Prepare sections of NIH grant applications and manuscripts.

Skills

Clinical research protocols

Analytical skills

Regulatory knowledge (GCP)

Statistical analysis

Data management

Education

Master of Science

Tools

SAS

Stata

Job description

Overview

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

University Overview: The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. Penn offers a unique working environment within the city of Philadelphia with access to a range of educational, cultural, and recreational activities. The University offers a competitive benefits package that includes healthcare and tuition benefits for employees and their families, generous retirement benefits, professional development opportunities, supportive work and family benefits, health and wellness programs, and more.

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

Job Profile Title: Manager Research Project B

Job Description Summary: Responsible for strategic planning and day-to-day management of a broad range of projects conducted with collaborators internal and external to the University. Take leadership in developing study protocols, writing grants, managing detailed operations of projects, analyzing qualitative and quantitative data, cultivating relationships with community partner organizations, and drafting/editing manuscripts for submission to peer-reviewed journals.

Job Description

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.
• Liaison 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 online clinical trial management databases 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 emerging clinical data and trends in cardiac surgery.
• Design and 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 health services research and quality analyses. Create analytic files. Develop standard statistical algorithms for hypothesis testing.
• Supervise students, Penn Surgery residents, fellows, lab members and mentor them in design of database systems.
• NIH Grant and Manuscripts - Technical Writing
• Prepare sections of NIH grant applications and manuscripts specific to Significance, Statistical Methods, Analyses, Findings, Conclusions, and References in collaboration with the faculty PI.

Qualifications

• Master of Science and 3 to 5 years of experience or an 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 relate to the position and market data. Internal organization and peer data at Penn are considered.

Equal Opportunity Statement
The University of Pennsylvania is an equal opportunity employer. Candidates are considered without regard to race, color, sex, sexual orientation, religion, creed, national origin, citizenship status, age, disability, veteran status or any protected characteristic under applicable law.

Special Requirements
Background checks may be required after a conditional job offer is made and will be tailored to the requirements of the job.

University Benefits

• Health, Life, and Flexible Spending Accounts: Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits are provided, with pre-tax accounts for eligible expenses.
• Tuition: Tuition assistance for employee and eligible dependents.
• Retirement: Generous retirement plans with investment options through TIAA and Vanguard.
• Time Away from Work: Substantial time off during the year for personal needs.
• Long-Term Care Insurance: Offered in partnership with Genworth Financial for eligible employees and family members.
• Wellness and Work-life Resources: Programs and resources to support health, family, and work-life balance.
• Professional and Personal Development
• University Resources: Access to libraries, athletic facilities, arboretum, galleries, and cultural events with many benefits.
• Discounts and Special Services: Discounts on arts, entertainment, transportation, mortgages, and more.
• Flexible Work Hours
• Penn Home Ownership Services: Forgivable loan program for eligible employees.
• Adoption Assistance: Reimbursement for qualified adoption expenses for up to two adoptions.

To learn more, please consider visiting the Penn HR benefits page. Equal Employment Opportunity Statement: The University of Pennsylvania is an equal opportunity employer. Candidates are considered without regard to race, color, sex, sexual orientation, religion, creed, national origin or any protected characteristic under applicable law.