Fortrea
Sr Clinical Data Specialist
San Jose · Senior
Sponsorship not specifiedDetected 20 days ago
GCPProject ManagementNegotiationMedical DevicesCommunication
About the role
- In this client-facing position, you will take ownership of external data oversight, including data acquisition, integration, review, and reconciliation from various third-party vendors such as central labs, imaging, and eCOA providers.
- Learn more about our EEO & Accommodations request here.
Responsibilities
- 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.
- 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.
- 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) training in a timely manner and perform job functions in accordance with set guidelines.
- 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.
Requirements
- Experience (Minimum Required):
- University/college degree in life sciences, health sciences, or related fields.
Nice to have
- Project Management experience strongly preferred.
- Strong organizational, planning, and critical-thinking skills.
- Strong negotiation skills to facilitate, guide, influence, and produce a unified approach within a global, cross-functional environment.
- 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.
- Understanding of ICH-GCP principle
Company info
- We are looking for a Sr Clinical Data Specialist to join our team in a client-dedicated role, supporting complex and innovative oncology studies.
- You will ensure external data is delivered in accordance with client quality standards, data integrity requirements, and study timelines.
- Acting as a key liaison between the client, vendors, and internal stakeholders, you will contribute to the development and execution of study-specific data strategies and play a critical role in ensuring the successful delivery of high-quality data for oncology clinical trials.
Visa & Work Authorization
- 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
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This listing is sourced directly from Fortrea's careers page and normalized into a canonical job model.