Senior External Data Specialist

🔥 13 hours ago

🇨🇦 Canada – Remote

💵 $85k - $100k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 0%

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Support the Lead Data Manager with review, maintenance, and updating of external vendor data • Develop Vendor Data Plans, including Data Quality Review reconciliation sections, obtain approvals, and file documentation to the Trial Master File • Collaborate with external vendors and sponsors on study expectations, milestones, deliverables, and communication • Ensure external vendor data transfers contain protocol-specified parameters, use the correct format, and populate specified fields and subjects correctly • Develop and document external data edit checks and reports; obtain approvals and perform QC/UAT • Review discrepancies generated by edit checks and reports and manage queries to resolve data issues • Maintain documentation of data issues in study and vendor logs through resolution • Assist with review of draft protocols and eCRF design from an external data perspective • Work with study team functions to gather feedback and address issues affecting data review or analysis • Obtain and QC local laboratory ranges and verify normal ranges are attached correctly to subject results • Participate in study team and department meetings • Plan and support multiple external data management projects and provide updates to management and stakeholders • Complete Fortrea and sponsor training and perform duties according to guidelines • Perform other assigned duties

🎯 Requirements

• University/college degree in life sciences, health sciences, information technology or related subjects preferred • Experience and/or education plus relevant work experience equating to a Bachelor’s degree accepted in lieu of a bachelor’s degree • Relevant and equivalent experience may be accepted in lieu of educational requirements • Fluent in English, both written and verbal • 4+ years prior experience in the pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries, or equivalent combination of education and experience • Project Management experience strongly preferred • Basic understanding of medical terminology a plus • Strong organizational, planning, and critical-thinking skills • Well-polished, inclusive, and engaging written and verbal communication skills • Strong negotiation skills • 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 • Understanding of ICH-GCP principles • Ability to work in a general or remote office setting • May be required to work minimal nights and weekends to support project deadlines, milestones, and deliverables

🏖️ Benefits

• All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data • Remote work arrangement • Less than 10% travel; travel is not extensive