We are looking for a Clinical Data Manager to join our team!
APPLY DIRECTLY at https://cpcclinicalresearch.org/careers/
If you enjoy science and data and are well-organized, please read on…
In this position you will:
- Design study electronic case report forms (eCRFs) according to CDISC standards and assist with basic programming logic.
- Define internal system queries/alerts to facilitate quality data 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.
- 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.
- 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).
- Represent the data management group as a member of project teams and in client meetings.
- Write and maintain department standard operating procedures (SOPs) and work instructions (WIs).
- Advise on appropriate resourcing and personnel allocation for evolving business and project needs within Clinical Data Management based on departmental metrics.
- Contribute to the achievement of departmental goals.
- Other duties as may be required by CPC management.
Here’s what you will need to bring to the table:
- A BS/BA degree in a scientific field with a minimum of 3 years experience in clinical data management or a minimum of 7 years experience in clinical data management.
- Experience programming and/or designing eCRFs within EDC platforms (DATATRAK, RedCap, and SAS experience is a plus).
- Demonstrated proficiency managing 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
- 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.
Note: Viable applicants will be required to demonstrate their computer skills as well as pass a background and education verification check.
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/
• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
• Matching 401(k) plan
• 10 paid holidays
• In-suite exercise room
• In-suite relaxation room
• Chair massages 3x month
• Monthly fun events (i.e. team building activities, games, charitable events, potlucks, picnics)
• Flexible work schedules
Visit our web site to learn more about us and values we embrace: https://cpcclinicalresearch.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 40 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 email@example.com.