ClinDatrix is looking to hire a full time in-house Senior Clinical Data Manager. The ideal candidate should be located in Southern CA and work in the ClinDatrix office. ClinDatrix is a small service provider, CRO, located in Irvine, CA dedicated to clinical research, data management, and statistical analyses and reporting servicing the biotechnology, medical device, and pharmaceutical industries.
Responsibilities
- Review Case Report Form (CRF) data for completeness, accuracy, plausibility, clinical correctness, and logical consistency.
- Identify data discrepancies in the CRF data via computerized edits, manual data checks, and tables and listings.
- Develop, validate, implement, run and maintain edit check programs to assist with the review and management of clinical data.
- Generate Data Clarification Forms (DCFs) and work with Clinical Research Associates (CRAs) and investigator sites to resolve data issues.
- Perform additional data review activities as required to provide clean data for the purposes of analysis.
- Update/correct data in the clinical databases based on the resolved DCFs.
- Code Adverse Events and Medications using MedDRA, WHO Drug or other standard dictionaries.
- Reconcile Adverse Event data reported on CRFs with Serious Adverse Event data reports or listings.
- Design, validate, implement and maintain clinical trial databases.
- Design and generate study specific Case Report Forms (CRFs) to ensure that data required by the protocol are accurately captured on the CRF.
- Assist with the development and maintenance of Case Report Form standards.
- Develop CRF Instruction Manuals to guide study investigators and site personnel in completing the CRF.
- Develop and maintain project-specific Data Management Plans based upon the protocol, statistical analysis plan, clinical monitoring plan and CRF to ensure that data collected during clinical trials are reviewed and managed to a level appropriate to allow for planned analyses and meet regulatory requirements for data quality.
- Develop protocol-specific Data Review Guides to facilitate the review of clinical data.
- Program and generate listings, tables and graphical displays.
- Maintain complete and auditable documentation of all data management project activities.
- Develop and generate project status reports for management.
- Coordinate data management projects and staff on all clinical trial projects in which clinical data management is performed at ClinDatrix.
- Assist with the development, review and modification of departmental Standard Operating Procedures (SOPs).
- Assist with training and mentoring of less experienced staff.
- Perform other general duties as required to support the company.
Qualifications and Requirements
- Bachelor’s degree or the equivalent in a scientific discipline
- Three to five years clinical data management experience, including database set up, edit check programming, patient data review and database finalization activities
- One or two years of a leadership role on a data management project
- Knowledge of database technologies and processes
- Familiarity with FDA regulations respecting data quality and clinical trials conduct
- Strong written and oral communication skills; excellent interpersonal skills
- Ability to work productively and efficiently within a team environment
- Ability to manage competing priorities in a changeable environment
- Ability to handle stressful situations and deadlines
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