Senior Clinical Data Manager
Company: ClinDatrix, Inc.
Posted on: April 5, 2021
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Home / Careers / Senior Clinical Data Manager 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.
- 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
- Generate Data Clarification Forms (DCFs) and work with Clinical
Research Associates (CRAs) and investigator sites to resolve data
- 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
- 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
- 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
- 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
- Develop protocol-specific Data Review Guides to facilitate the
review of clinical data.
- Program and generate listings, tables and graphical
- Maintain complete and auditable documentation of all data
management project activities.
- Develop and generate project status reports for
- Coordinate data management projects and staff on all clinical
trial projects in which clinical data management is performed at
- Assist with the development, review and modification of
departmental Standard Operating Procedures (SOPs).
- Assist with training and mentoring of less experienced
- Perform other general duties as required to support the
company. Qualifications and Requirements
- Bachelor's degree or the equivalent in a scientific
- 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
- Knowledge of database technologies and processes
- Familiarity with FDA regulations respecting data quality and
clinical trials conduct
- Strong written and oral communication skills; excellent
- Ability to work productively and efficiently within a team
- Ability to manage competing priorities in a changeable
- Ability to handle stressful situations and deadlines To start
the conversation, please write, fax or click--here . Primary
Sidebar Contact Us Take advantage of our value and experience.
ClinDatrix, Inc. * 1 Ada, Suite 250 * Irvine, CA 92618 * Tel:
949.428.6600 * Fax: 949.428.1239
Keywords: ClinDatrix, Inc., Irvine , Senior Clinical Data Manager, Healthcare , Irvine, California
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