Senior External Data Specialist - FSP

Job Overview:

May support Lead Data Manager (LDM) with the review, maintenance, and update of external vendor data received from central vendor or local laboratories. Working to ensure company SOPs (or sponsor, if applicable), guidelines and global standards are followed to maintain data integrity and ensure consistency across all projects.

Summary of Responsibilities:

• Develop 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.
• 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.
• Develop and document 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.
• Review 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.

Qualifications (Minimum Required):

• University/college degree (life sciences, health sciences, information technology or related subjects preferred).
• Experience and/or education plus relevant work experience, equating to a Bachelors degree will be accepted in lieu of a bachelor’s degree.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.

Experience (Minimum Required):

• 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 principles

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