External Data Reviewer
Labcorp Drug Development
San José, Costa Rica
hace 6 días

Job Overview :

Ensure electronic vendor data contains all protocol specified parameters, is in correct format and data populates to the specified fields and patients correctly

May support LDM in the development of the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers.

Review data discrepancies generated by study specific edit checks for External data and perform the subsequent query management process in resolving the data issues.

May support LDM to perform validation review of the electronically transmitted data for a sample of total number of patients in the study for loading purposes.

Assist with review of External Data edit checks, External Data status reports and External Data listings.

Interact with Clinical staff (CTM / CRA) to obtain local laboratory normal ranges for all sites. Research and resolve discrepant information concerning the normal ranges and maintain proper documentation.

Enter and perform QC for local laboratory normal ranges. Verify the normal ranges are properly attached to the patient results in the local lab data collection module of the database.

May support LDM to communicate to vendors and client problems involving data transfers, data point issues and validation issues with initial oversite for support of this communication from EDS 2 or above.

Perform other duties as required by the Department.

Education / Qualifications :

University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.

Fluent in English, both written and verbal.

Experience :

3 years’ prior experience in the pharmaceutical, biotechnology, medical device / diagnostics, or clinical trial industries or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.

Basic understanding of medical terminology a plus.

Strong organizational, planning, and critical-thinking skills.

Well-polished, inclusive, and engaging communication skills (written and verbal) to support effective interactions with sponsors and internal colleagues.

Ability to handle multiple tasks in a timely and professional manner under demanding conditions.

Ability to use standard Microsoft suite of software products.

Strong technical aptitude.

Ability to maintain confidentiality of data and information during interaction with staff at all levels.

Understanding of ICH-GCP principles.

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