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Data Specialist, Clinical Affairs Job in Cincinnati, Ohio US

Data Specialist, Clinical Affairs

Atricure, Inc. - Cincinnati, OH

Posted: 8/2/2021 - Expires: 10/31/2021

Job ID: 230161068

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Job Description

Data Specialist, Clinical Affairs

Cincinnati, OH, USA * Mason, OH, USA
Req #502

Monday, August 2, 2021


As a leading provider of innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions, electrophysiologists and cardiothoracic surgeons around the globe count on AtriCure to deliver best-in-class solutions that can treat even the most complex cases. Our Isolator Synergy Ablation System is the first and only medical device approved by the FDA for the treatment of long standing persistent Afib, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, and we are expanding into pain management therapies. We invest in innovation, clinical science, and education to focus on improving lives for our patients' worldwide.

POSITION SUMMARY:

The Data Specialist, Clinical Affairs ensures clinical data collection and processing that meets standards of data quality, validity, and security. Data Specialist responsibilities include assisting in clinical database/CRF design, data collection, and processing for final database preparation activities associated with clinical trials for submission to regulatory agencies throughout the world. The Data Specialist 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:

Assist with all data management responsibilities in support of clinical study teams and as defined in policies and procedures
Collaborates with Clinical Study Team to create protocol case report forms (CRF)
Perform User Acceptance Testing (UAT) and assist with Validation of the EDC database
Assist with development of Data Management Plan (DMP) to define the data collection and processing workflow
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
Assist with coordination of the development of Case Report Forms or EDC forms with clinical and biostatistics groups
Train clinical personnel on CRFs and EDC as needed
Assist with 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 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
Additional duties as assigned

BASIC QUALIFICATIONS:

Bachelor's degree in Science required or demonstrated equivalent combination of education, training and experience
At least 3 years of clinical data management 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
Prior use of commercially available EDC systems required
Data analysis and data entry experience
Problem-solving/trouble-shooting experience
Effective communication and organizational skills
Ability to travel 10%

PREFERRED QUALIFICATIONS:

BS in science or related technical field or equivalent experience and at least 3 years clinical trials experience
EDC systems experience, database build, SQL and programming experience
Experience with Clindex or Medidata RAVE

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

#LI-RW1

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).

Other details

Job Family
Clinical Affairs

Job Function
Clinical

Pay Type
Salary

Employment Indicator
Non Manager

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with disability.

Job Summary

Employment Type:
Full Time Employee
Job type:
Federal Contractor
Skill Based Partner:
No
Education Level:
Bachelor's degree
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
58140340
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
N/A