Principal Clinical Data Scientist

🔥 26 minutes ago

🌐 United Kingdom, Hungary, +5 more countries – Remote

🇬🇧 United Kingdom – Remote 🇭🇺 Hungary – Remote 🇵🇱 Poland – Remote 🇷🇴 Romania – Remote 🇷🇸 Serbia – Remote 🇸🇰 Slovakia – Remote 🇪🇸 Spain – Remote

⏰ Full Time

🔴 Lead

📊 Data Scientist

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Serve as the CSAI functional lead on assigned project teams • Manage the operational clinical science function from study start-up through database lock • Provide scientific and clinical input into data capture, review, cleaning, eCRF specifications, edit checks, completion guidelines, and EDC UAT • Support and manage integrated cross-functional data-cleaning processes for interim and final study deliverables • Manage Medical Monitor review of subject data • Provide protocol review from a scientific operational perspective • Identify study risks and manage CSAI study-specific deficiencies • Support monthly invoicing and variance management of the CSAI budget • Manage CSAI resource needs and maintain project plans, guidelines, trackers, and eTMF documentation • Conduct holistic and aggregate clinical data review using programmed outputs, listings, metrics, and graphs • Oversee and resolve queries in EDC systems and report or escalate data review findings • Manage development and UAT of CSAI programmed outputs • Provide study-specific training and participate in internal and external meetings and presentations • Support data-related committees, TLF/CSR review, interviewing, business development, SOPs, trainings, and process improvement initiatives • Promote Precision’s quality and ethical image and perform other duties assigned by management

🎯 Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related discipline with proficiency in medical terminology • Minimum of 8 years of clinical research experience or proven competencies for this position • Minimum of 1 year of leadership experience • Experience with electronic data capture systems • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) • Professional use of the English language, both written and oral • Ability to occasionally travel domestically and internationally including overnight stays • Highly advanced knowledge in oncology and medical terminology, including disease assessment criteria, standards of care, and grading criteria • Working knowledge of FDA and ICH-GCP, relevant SOPs, regulatory guidance, clinical trial processes, and clinical research functional departments • Ability to independently manage the CSAI operational function in a global, cross-functional environment • Ability to apply financial management skills at the functional area project level

🏖️ Benefits

• Remote work arrangement • Opportunity to work in a global, cross-functional environment • Equal opportunity employment • Reasonable accommodation for applicants with disabilities