Senior Clinical Database Programmer
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
POSITION SUMMARY:
The Senior Clinical Database Programmer (CDP) responsibilities include clinical database/CRF design, database build, and database validation for final database preparation activities associated with clinical trials for submission to regulatory agencies, as well as exempt studies. As a member of the data management team, the Senior CDP will work collaboratively with biostatistics, clinical, safety, and regulatory groups within the company, and with CROs, and globally as needed.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Develop, program, validate and maintain EDC clinical trial databases according to company standards
- Designs Electronic Data Capture (EDC) databases to collect and process CRF data. May include coordination with EDC vendors and programmers to deliver a validated system
- Develop SAS programs to extract EDC data for statistical analysis
- Develop User Acceptance Testing (UAT) requirements and perform UAT of the EDC database
- Conduct data processing and review in accordance with the study protocol, DMP, and EDC system instructions
- Generate standard and ad hoc reports of EDC CRF or metric data for study team and management reporting
- Collaborates on the development of Case Report Forms or EDC forms with clinical and biostatistics groups
- Coordinate with data manager and other vendors (CRO, core labs, adjudicators, etc.) to ensure successful integration of internal and external data sources into the analysis database
- Provides database programming expertise on clinical study teams and train clinical personnel on EDC as needed
- Perform database lock activities to ensure the accuracy and completeness of final clinical trials databases prior to submission to Biostatistics for analyses and submission to the FDA and other regulatory agencies in other countries
- Participate as a clinical study team member and contribute to team deliverables to include protocol design, site EDC training, and study conduct activities through completion of the study report. May include performance of Quality Control checks for study documents and data output
- Participate in departmental developmental initiatives (e.g. training, SOP development, etc.)
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- Regular and predictable work performance
- Ability to work under fast-paced conditions
- Ability to make decisions and use good judgment
- Ability to prioritize various duties and multitask as required
- Ability to successfully work with others
BASIC QUALIFICATIONS:
- Bachelor’s degree in science or related field or demonstrated equivalent combination of education, training and experience
- At least 3 years of clinical database programming experience in a pharmaceutical, medical device or CRO environment
- Familiarity with and knowledge of personal computers and database management software, MS word, and MS excel
- EDC systems experience, data-base build, SQL and programming experience
- Data analysis and data entry experience
- Problem-solving/trouble-shooting experience
- Effective communication and organizational skills
- Ability to travel 10%
PREFERRED QUALIFICATIONS:
- Bachelor's degree in science or related technical field experience
- Three years Clinical trial experience
- Knowledge of SAS programming
- Experience with Clindex, Medidata RAVE or other commercially available EDC systems
OTHER REQUIREMENTS:
- Ability to regularly walk, sit, or stand as needed
- Ability to occasionally bend and push/pull as needed
- Ability to regularly lift up to 25 pounds, occasionally lift up to 25 pounds
- Ability to pass pre-employment drug screen and background check
- Position dependent upon candidate passing pre-employment physical/drug screen
AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 15 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/benefits AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).