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

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

In this position you will:

  • Ensure complete, consistent, and logical clinical study data for delivery to biostatistics and programming.
  • Participate in review of clinical study documents (e.g. protocol, study plans) and assist with the design and development of electronic case report forms (eCRFs) according to CDISC standards.
  • For studies utilizing an electronic data capture (EDC) system, define internal system queries/alerts to facilitate quality data upon entry.
  • Develop external edit check specifications to identify all planned programmatic and manual edit checks to be systematically performed during the course of the trial.
  • 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 queries for trends and assist with developing solutions to mitigate issues.
  • 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.

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.
  • 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.
  • Proficiency in Microsoft® Office, specifically Excel.

Note: Viable applicants will be required to demonstrate their computer skills as well as pass a background check.

About CPC:

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

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.)

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, gender, gender identity, veteran status, marital status, sexual orientation, age, 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 email our Human Resources team.