Clinical Data Manager I

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

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

In this position you will:

• Review database specifications.
• Assist with designing study electronic case report forms (eCRFs) according to CDISC standards.
• Assist with defining internal system queries/alerts to facilitate quality data entry.
• Assist with defining external edit checks and run and review output to identify discrepancies and/or illogical data.
• Collaborate on the initial development of Data Management Plans (DMPs).
• Maintain DMPs throughout the lifecycle of study projects and ensure team adherence to said plans.
• Collaborate on initial development of eCRF Completion Guidelines (CCGs) and train internal and external team members on data entry.
• Maintain the CCGs throughout the lifecycle of study projects.
• Perform eCRF data review to ensure complete, consistent, and logical data, 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 for adverse events, medical history, and concomitant medications.
• Assist with coordination of Clinical Database locks, archival, exports and transfers to other individuals within CPC and/or to external parties, as appropriate.
• Participate in review of clinical study documents (e.g. protocol, study plans).
• Represent the data management group as a member of project teams and in client meetings.
• Contribute to the achievement of departmental goals.
  

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

• A BS/BA degree with a minimum of 1 year’s experience in Clinical Data management or a commensurate experience.
• Experience reviewing and/or designing eCRFs.
• Experience working within EDC platforms (DATATRAK, REDCap Classic, and REDCap Cloud experience is a plus).
• Experience working on Clinical Data projects from initial eCRF/database design to database closure.
• Working knowledge of CDISC-CDASH/SDTM standards.
• Familiarity with medical terminology and ability to code medical terms in MedDRA/WHODrug.
• Knowledge of GCP, ICH and FDA requirements as they apply to Clinical Data Management. 
• Familiarity with risk-based quality management approaches and analysis. 
• Good interpersonal communication skills, organizational skills, and attention to detail
• Ability to delegate, plan and manage projects.
• Ability to work as a member of a team.
• Comprehension of study documentation and archival processes.
  

Note: Viable applicants will be required to pass a background and education verification check.

Targeted Compensation: $60,000 - $75,000

About CPC:

CPC is an academic 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 30 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:

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
• Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
• 10 paid holidays
• 15 - 25 vacation days based on years of service
• Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) 
• In-suite exercise and relaxation room
• Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
• Flexible and remote work schedules

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 email our Human Resources team at careers@cpcmed.org.