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Company Contact Info
- Minneapolis, MN
- Eden Dolarian
- Phone: 7639232061
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Clinical Data Specialist
Aerotek • Minneapolis, MN
Posted 1 month ago
Clinical Data Specialist
INTRO: The candidates in this role require a bachelors degree at minimum. Opportunity to work remotely, only in following cities.
Mounds View, MN
This position is responsible for ongoing support for data management activities which assure quality of data delivery.
- interacts with internal data management (Clinical IT Development and Statistical Programmers) colleagues and MCO partners and possibly business partners including clinical study teams, Global IT, business strategists, and statisticians for the purpose of data management, system development, and data cleaning activities across multiple trials.
- supports or executes the development of data management tools, data quality, and data review activities.
- may lead data management processes for low to medium complex studies (with oversight or mentoring)
- may support and/or work with additional project teams, disciplines, or functions company.
- Supports all aspects of Data Management, including:
- creation of Case Report Form (CRF) specification and design and the specification of Edit Check requirements.
- supporting and/or executing the validation and testing procedures of clinical database, eCRF and edit checks (eg, 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.
- defining 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.
Bachelors degree required (life sciences preferred)
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.