ROLE TITLE                        CLINICAL DATA ASSOCIATE

DEPARTMENT                   CLINICAL  

SUPERVISOR                      SR. VP, CLINICAL AFFAIRS

FLSA                               EXEMPT

 CORE VALUES 

RESPECT ● PASSION ● TEAMWORK ● INTEGRITY ● HONESTY ● COMMITMENT ● COLLABORATION

FUNCTION SUMMARY      CLINICAL DATA ASSOCIATE

The Clinical Data Associate is responsible for being a member of the Clinical Affairs group, working closely with the clinical research groups. The ideal candidate will  participate in the collection, analysis and reporting of data for multiple clinical studies accurately and according to project timelines. In this role the Clinical Data Associate will be operating in a fast-paced, dynamic environment where employees are expected to be adaptable and willing to take on additional responsibilities as required.

 DUTIES & RESPONSIBILITIES:

• Participates in overseeing data management, programming, and biostatistical activities for start up and execution of clinical studies by external vendors and academic collaborators.
• Provides input in the development of CRF’s, data entry instructions, databases, data management and data validation plans, specifications of analysis datasets and statistical analysis plans.
• Assists with edit check specifications, validation and user acceptance testing of data systems.
• Manages and performs ongoing data management activities including CRF review, query generation, receipt and reconciliation of external data.
• Writes SAS programs to generate tables and listings to facilitate data cleaning and data review.
• May program SAS edit checks and SAS macros for data cleaning.
• May generate statistical programming for clinical studies to create tables, figures and listings.
• Responsible for accurate and timely filing and maintenance of clinical study data.

EDUCATION & EXPERIENCE

• Bachelor’s degree (BA/BS) in a technical, science or health related field.
• Minimum of 2 years of direct Clinical Data Management experience in the pharmaceutical, biotechnology, medical device/diagnostic, CRO or academic setting.
• Experience and knowledge of clinical study protocols, clinical databases, electronic data capture systems (EDC), IWRS, quality control processes and auditing procedures.
• Working knowledge of CDISC CDASH and CDISC SDTM standards/guidelines preferred.
• SAS experience preferred.
• Familiar with GCP, ICH, FDA, and EMA requirements as they apply to clinical data.
• Proficiency in MS Office including Word, Excel and PowerPoint required.
• Excellent at communication and pays good attention to detail.
• Good organizational skills and able to work on multiple tasks simultaneously.
• Exercises good judgement in selecting methods and techniques for obtaining solutions.
• Requires little instruction on day-to-day work, general instructions on new assignments.
• If manger position, they should be able to leverage their experience to support process improvements and/or implement processes, etc.
• Flexible and works well in a team setting.

 SKILLS & COMPETENCIES

•  Proficiency in MS Office including Word, Excel and PowerPoint required.
• Excellent at communication and pays good attention to detail.
• Good organizational skills and able to work on multiple tasks simultaneously.
• Exercises good judgement in selecting methods and techniques for obtaining solutions.
• Requires little instruction on day-to-day work, general instructions on new assignments.
• If manger position, they should be able to leverage their experience to support process improvements and/or implement processes, etc.
• Flexible and works well in a team setting.