Associate Eds Lead - San José, Costa Rica - Fortrea

Descripción

Support development of the Vendor Data Plan (VDP), including the Data Quality Review reconciliation section, or sponsor equivalent, for the external vendor data transfer(s), obtain final approvals and file document to the Trial Master File (TMF) as applicable.

• Collaborate with external vendor and sponsor counterparts for study expectations including milestones, deliverable timelines, communication expectations, etc.
• May participate in review of external vendor Statement of Work (SOW) for study scope, and ensure all protocol specified parameters are present as applicable.
• Assist with development and documentation of external data edit checks and reports in the edit check template or sponsor equivalent, obtain approvals and perform QC/UAT to verify the checks and reports are functioning properly.
• Assist with review of external data discrepancies generated by edit checks and reports and perform subsequent query management to resolve data issues.
• Maintain appropriate documentation of data issues in both study and vendor logs and follow outcome to resolution.
• May assist with review of draft protocols from an external data perspective and assist with review of eCRF design per protocol parameters.
• Work with other study team functions to gather feedback and address any issues that could impact data review or analysis.
• Participate in study team and department meetings as applicable.
• Effectively plan and support multiple high quality external data management projects simultaneously and provide updates to line management or other relevant stakeholders as requested.
• Complete Fortrea and sponsor (if applicable) trainings in a timely manner and perform job functions in accordance with set guidelines.
• Perform other duties as required by the department.

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.

We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.