What are the responsibilities and job description for the Clinical Data Manager I - RMS position at Software Guidance & Assistance, Inc. (SGA, Inc.)?
Software Guidance & Assistance, Inc., (SGA), is searching for a Clinical Data Manager I – RMS for a CONTRACT assignment with one of our premier Pharmaceutical Services clients in Tucson, AZ.
Responsibilities:
Performs data management activities for both clinical studies and development projects as assigned. Ensures the delivery of complete, accurate data that is ready for analysis and regulatory submission. Supports all data-related activities including data entry, verification and scribing when needed.
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.
Responsibilities:
Performs data management activities for both clinical studies and development projects as assigned. Ensures the delivery of complete, accurate data that is ready for analysis and regulatory submission. Supports all data-related activities including data entry, verification and scribing when needed.
- Supports Lead Data Managers in execution of assigned tasks.
- Assists and contributes to the compilation of all data management documentation for assigned projects. Reviews and adheres to the requirements of study specific DMP.
- Prepares and enters test data for user testing of clinical database and edit checks.
- Participates in study-specific data entry training and serves as backup to data entry staff.
- Performs basic clinical study data review as required by the DMP. Identifies incomplete, erroneous, and/or discrepant data.
- Generates discrepancies and updates clinical database based on queries, data clarification forms, discrepancy management guidelines, and performs other database changes as necessary for a study.
- Assists in preparation of relevant subject data files and study documentation for audits and quality control.
- Performs other duties as assigned.
- Bachelor's Degree – REQUIRED
- Ability to work with relevant computer software, including spreadsheets, word-processing and database packages (e.g., Microsoft Excel, Word, and Access).
- Excellent communication and interpersonal skills.
- Ability to work under time pressure while maintaining high standards of precision and data quality
- Travel Requirements: 10% Based on business needs
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.