Sr Clinical Data Specialist

Fortrea•San Jose, CA

About The Position

Exciting Job Opportunity: We are looking for a Sr Clinical Data Specialist to join our team in a client-dedicated role, supporting complex and innovative oncology studies. 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. 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. Summary of 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.

Requirements

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

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.