CLINICAL DATA MANAGER

Posting Details

Posting Details

Reference Number 40-27263
Posted Job Title CLINICAL DATA MANAGER
School Name Perelman School of Medicine
Org CI-Center for Cellular Immunotherapy
Posted to the Web 11/13/2017
Posted Job/Salary Grade 027
Employment Type Exempt
Hours N/A
Position Type Full Time
Position Schedule 8-5pm
Months 12
Position Length Contingent Upon Funding
Position End Date
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.

School/Center Overview

The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/

Duties

The Clinical Data Manager (CDM) is responsible for data quality and documentation for assigned clinical trials conducted within the Center for Cellular Immunotherapies to ensure that the clinical data collection is accurate and all protocol requirements are captured. The Clinical Data Manager is responsible for providing clinical data management support for assigned Center for Cellular Immunotherapies (CCI)-Initiated protocols, including all tasks associated with study data management necessary for DSMB meetings/reports, IND Annual Reports, monthly reports, and interim data reporting/database locks, as well as ad hoc queries.
In addition, the Clinical Data Manager (CDM) will:
* Independently create CRFs (Case Report Forms) in an electronic database systems to collect required data from all clinical trials. The Clinical Data Managers ensures data collection is accurate, capturing all activities required by the protocol including, but not limited to all data groups such as: enrollment information, clinical labs/procedures, demographics, infusion information, response data, etc. The CDM must be able to understand the needs of complex, high-risk, gene and immunotherapy clinical research protocols, and accurately build case report forms that capture required research information to ensure primary and secondary endpoints are captured.
* Continually evaluate the CRFs for required modification due to the dynamic nature of this research. Amend CRFs due to protocol amendments/changes in study endpoints.
* Assist in the development and review of study-specific data management documents, including Data Management Plans and Case Report Form Completion Guidelines, as well as sponsor data management standard operating procedures.
* Develop and conduct Investigator/Study Team training on the Clinical Database, CRFs, and data entry requirements.
* Provide input into study and project level data analysis plans.
* Participate in the preparation and presentation of study data/reports.
* Facilitate data cleaning activities including data review and query generation for assigned protocols
* Produce and provide metrics on data entry/processing to the Project Manager.
* Assist in implementing process changes and system improvements.
* Coordinate the archiving of study data and study related documents for assigned protocols.
* Interact with the Sponsor/Sponsor Program Managers, Project Managers, Monitors, Statisticians, Clinical Investigators, Clinical Cell and Vaccine Production Facility (CVPF), and Translational and Correlative Studies Lab (TCSL) to ensure required data is captured.

To be successful in this role the Clinical Data Manager will need to maneuver within a matrixed environment and be comfortable working with various electronic database systems. The Clinical Data Manager is also expected to have familiarity and experience with clinical trial protocols and related regulatory requirements for therapeutic clinical trials.

In addition, the Clinical Data Manager (CDM) will:
* Independently create CRFs (Case Report Forms) in an electronic database systems to collect required data from all clinical trials. The Clinical Data Managers ensures data collection is accurate, capturing all activities required by the protocol including, but not limited to all data groups such as: enrollment information, clinical labs/procedures, demographics, infusion information, response data, etc. The CDM must be able to understand the needs of complex, high-risk, gene and immunotherapy clinical research protocols, and accurately build case report forms that capture required research information to ensure primary and secondary endpoints are captured.
* Continually evaluate the CRFs for required modification due to the dynamic nature of this research. Amend CRFs due to protocol amendments/changes in study endpoints.
* Assist in the development and review of study-specific data management documents, including Data Management Plans and Case Report Form Completion Guidelines, as well as sponsor data management standard operating procedures.
* Develop and conduct Investigator/Study Team training on the Clinical Database, CRFs, and data entry requirements.
* Provide input into study and project level data analysis plans.
* Participate in the preparation and presentation of study data/reports.
* Facilitate data cleaning activities including data review and query generation for assigned protocols
* Produce and provide metrics on data entry/processing to the Project Manager.
* Assist in implementing process changes and system improvements.
* Coordinate the archiving of study data and study related documents for assigned protocols.
* Interact with the Sponsor/Sponsor Program Managers, Project Managers, Monitors, Statisticians, Clinical Investigators, Clinical Cell and Vaccine Production Facility (CVPF), and Translational and Correlative Studies Lab (TCSL) to ensure required data is captured.

Qualifications

A Bachelor’s Degree and 3 years to 5 years of experience (preferably in clinical data management/clinical data analysis), or an equivalent combination of education and experience, are required.
Solid clinical research background; Understanding of and experience in all aspects of data cleaning procedures.
Knowledge of electronic data capture systems required.
Experience with advanced computer applications (i.e. electronic medical record, electronic appointment scheduling, excel, electronic data capture)
Good understanding of and/or experience with descriptive data analysis methods, the drug development process and associated federal regulations and guidelines (i.e. FDA, CFR, ICH, GCP).

Preferred experience/skills:
* Strong problem-solving and organizational skills
* High attention to detail
* Demonstrated ability to manage multiple tasks simultaneously and complete work within allocated time frames
* Excellent oral and written communication skills

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
Quick Link http://jobs.hr.upenn.edu/postings/32751

Posting Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this employment opportunity?
    • Jobs@Penn
    • Contacted by a Penn Recruiter
    • Referred by a Penn Employee
    • Referred by a friend or family member
    • Higher Education Recruitment Consortium (HERC)
    • Inside Higher Ed
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    • Professional Affiliation/Trade Website
    • Diversity Association/Publication Website
    • Heard about it at a conference or career fair
    • Apple One
    • Recruitment and/or staffing agency
  2. * What is your highest level of education completed?
    • Less than high school education
    • High School Diploma or GED
    • Vocational or Technical School
    • Associate's Degree or Two Year College
    • Bachelor's Degree
    • Master's Degree
    • PHD/MD/JD or equivalent doctoral degree
  3. * How many years of experience do you have related to this position?
    • 0 to 1 Year
    • 1 to 2 Years
    • 2 to 3 Years
    • 3 to 5 Years
    • 5 to 7 Years
    • 7 to 10 Years
    • Over 10 Years

Applicant Documents

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter