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Clinical Data Manager/Architect

27 - Data Management – Aurora, Colorado
Department 27 - Data Management
Employment Type Full-Time
Minimum Experience Experienced

We are looking for a Clinical Data Manager/Architect to join our team!

If you enjoy science and data and are well-organized, please read on…

In this position you will:

  • Design and program study electronic case report forms (eCRFs) according to CDISC standards
  • Define internal system queries/alerts to facilitate quality data upon entry
  • Define and run external programmatic edit checks to identify discrepancies and/or illogical data
  • Develop Data Management Plans (DMPs), maintain DMPs throughout lifecycle of study project and ensure team adherence to said plans.
  • Write eCRF Completion Guidelines (CCGs) and train internal and external team members on data entry.
  • Throughout the course of a trial, perform reviews of data to ensure they are complete, consistent, and logical and work with the project team as applicable to resolve discrepancies.
  • Review data and metrics for trends and assist with developing solutions to mitigate issues and escalate as necessary
  • Perform medical coding of adverse events, medical history, and concomitant medications.
  • Coordinate clinical database locks, archival, exports and transfers to other individuals within CPC and/or to the sponsor.
  • Participate in review of clinical study documents (e.g. protocol, study plans)

 Here’s what you will need to bring to the table:

  • A minimum of a BS or BA degree in a life science or health related field with a minimum of 2 years experience in data management in the industry, or a minimum of 5 years experience in data management in the industry.
  • Experience programming and/or designing eCRFs within EDC platforms
  • Demonstrated proficiency managing clinical data projects from initial eCRF/database design to database closure.
  • Experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes.
  • Knowledge of GCP, ICH and FDA requirements as they apply to Clinical Data Management.   
  • Excellent interpersonal communication skills, organizational skills, attention to detail, and ability to delegate, plan and manage projects.
  • Ability to work as a member of a team.
  • Comprehension of study documentation and archival processes.

About CPC:

CPC Clinical Research is an academically led clinical research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 25 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.

CPC Clinical Research has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials. www.cpcmed.org.

CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/

CPC offers a comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) In addition, our team members get to enjoy in-suite exercise and relaxation room, chair massages and monthly fun committee events.

Visit our web site to learn more about us and values we embrace: www.cpcmed.org.

An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, sex, gender identity, veteran status, marital status, sexual orientation, age forty and over, disability, genetic information or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please e-mail our Human Resources team at careers@cpcmed.org.

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  • Location
    Aurora, Colorado
  • Department
    27 - Data Management
  • Employment Type
  • Minimum Experience
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