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Fortrea · 1 day ago

Sr Clinical Data Specialist

San Jose

Full-time

Hybrid

Mid, Senior Level

4+ years exp

Fortrea is seeking a Sr Clinical Data Specialist to join their team in a client-dedicated role supporting complex oncology studies. This role involves external data oversight, ensuring data integrity and quality while acting as a liaison between clients, vendors, and internal stakeholders.

Clinical TrialsHealth Care

H1B Sponsor Likely

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

May participate in review of external vendor Statement of Work (SOW) for study scope, and ensure all protocol specified parameters are present as applicable

Ensure electronic external vendor data transfers contain all protocol specified parameters, is in correct format, and data populates to the specified fields and subjects correctly as designated in the Vendor Data Plan (VDP) or sponsor equivalent

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

May work with clinical staff to obtain and QC local laboratory ranges and verify the normal ranges are properly attached to the subject results in the local lab data

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) training in a timely manner and perform job functions in accordance with set guidelines

All other duties as needed or assigned

Qualification

ICH-GCPProject ManagementMedical TerminologyData ManagementTechnical AptitudeMicrosoft SuiteCommunication SkillsOrganizational SkillsNegotiation Skills

Required

University/college degree in life sciences, health sciences, or related fields

4+ 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

Project Management experience strongly preferred

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

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

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

Understanding of ICH-GCP principle

Company

Fortrea

Fortrea is a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions.

Founded in 2023

Durham, North Carolina, USA

10001+ employees

https://www.fortrea.com

H1B Sponsorship

Fortrea has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (14)

2024 (25)

2023 (6)