Clinical Research Data Specialist
4851 Lyndon B Johnson Freeway Suite 400 Dallas, Texas 75244
A rapidly growing company in MedTech with a range of disruptive products in disruptive clinical surgical area is seeking to add a Clinical Database Specialist..
If you are passionate about helping support clinical trials that are saving lives - and the opportunity to work in a hyper growth fast-paced environment with leadership whose names you'll recognize from their past remarkable wins in wildly successful medical device companies, you'll want to talk to us.
THIS IS "THAT" COMPANY people are talking about.
Responsibilities (Not a complete list)
- Lead and support clinical database build activities for EDC clinical studies including Review and finalization of case report forms (CRFs)
- Lead database build and validation with appropriate documentation for assigned studies and perform data extraction to relevant SAS or Excel datasets
- Responsible for User Access Management for Clinical Systems
- Develop, document and maintain assigned study data management plans including data entry guidelines, and provide training for team members including collaboration with IT and other cross-functional teams to clarify and finalize specifications
- Ownership of clinical database build activities for EDC clinical studies including
planning, implementation and overall direction of executing clinical trial data management: protocol review, electronic system configuration, validation programming, and discrepancy management.
- Facilitate the correction of errors and discrepancies through the site query process, document permanent data issues, communicate issues with team members, and deliver a quality locked database for analysis.
- Provides technical support on Data Management/Clinical systems including CDMS / EDC packages including Rave, Oracle Clinical, reporting tools, custom functions
• 5+ Years Hands-on Oracle Clinical programming experience in T-SQL, Databases (Oracle, SQL), and one or more programming scripting language such as C#, Java, Visual Basic, etc.
• Knowledge of FDA regulations including 21 CFR Part 11
• Bachelors Degree + in scientific, clinical, computer science, IT or similar discipline.
Arshad is a seasoned recruiter in the healthcare space with over 15 years of experience in promoting career growth for healthcare professionals. He has played a critical role in the launch of several startup companies. He is known for versatility and leadership; expert in overseeing high-level priorities and a broad range of responsibilities.