Clinical Data Specialist
Mounds View, MN
The role of the Clinical Data Specialist is to supports all aspects of Data Management, support and/or execute the validation and testing procedures of clinical databases, eCRF and edit checks and define data review requirements and processes to ensure delivery of highest quality of data. The role is located in Saint Paul, Minnesota. Clinical Data Specialists are encouraged to have a good understanding of the clinical research life cycle process, knowledge in medical devices and/or pharmaceutical data management environment and clinical database systems knowledge.
- Supports all aspects of Data Management
- Creation of Case Report Form (CRF) specification and design and the specification of edit check requirements
- Support and/or execute the validation and testing procedures of clinical database, eCRF and edit checks (e.g., Functional and User Acceptance Tests) which may include writing test scripts
- Data entry and data reporting
- Data review and discrepancy management in accordance with data management plan and data review guidelines
- Define data review requirements and processes to ensure delivery of highest quality of data
- Ensures timely and successful execution of the assigned data management tasks
- Participates in project meetings to provide status updates to stakeholders
- Provides communication of risk and mitigation for all data management related deliverables
- Assists in overall project tasks such as process flowcharts, standard operating procedures (SOPs), work instructions, training guidelines, etc
- Assists in FDA and Quality audits that involve data management
- Supports the creation and maintenance of all essential data management documentation, such as CRFs and annotated CRFs, data management plans, data review guidelines, CRF completion guidelines, data entry guidelines, testing plans, and other study specific work instructions or guidelines for assigned projects to ensure compliance to quality system
- Remains current on data management technology, processes, and best practices via reading, formal course work, membership in professional organizations, etc
- Follows and implements data management standards and best practices and assures standard operating procedures compliance (eg, use of standardized Case Report Forms, univariate versus multivariate edit checks, reusable edit check specifications)
- Monitors key performance indicators and takes appropriate action based on results
- 2-4 years of experience
- 0-2 years of experience with Master’s degree
- Bachelor’s degree
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.