Principal Clinical Data Scientist

🕒 May 11

🌐 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

👻 Ghost score 68%

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Manage the operational clinical science function from study start-up through database lock for assigned projects • Provide scientific and indication-specific insights into data collection and visualization outputs • Support scientific, clinical-sense data cleaning as part of the cross-functional data review team • Serve as the clinical knowledge, guidelines, and standards-of-care subject matter expert for clinical trial data review • Serve as CSAI functional lead on project teams, delivering within scope, time, and cost • Implement CSAI services according to the study scope of work • Support scientific data capture, review, and cleaning • Develop and implement cross-functional data-cleaning processes for interim and final study deliverables • Manage Medical Monitor review of subject data • Provide scientific operational protocol review • Support development and revision of eCRF specifications, edit checks, completion guidelines, and study documentation • Support EDC user acceptance testing • Coordinate cross-functional communication regarding data capture, review trends, EDC updates, and CSAI programming needs • Identify study risks and manage CSAI-specific deficiencies • Support monthly CSAI invoicing and budget variance management • Ensure CSAI resource needs are addressed when scope changes • Develop and maintain project plans, guidelines, and trackers • Maintain applicable eTMF documentation according to project plans and SOPs • Conduct holistic and aggregate scientific/clinical data review using programmed outputs, listings, quality metrics, and graphs • Oversee and resolve queries in EDC systems • Provide status updates on data review findings and escalate issues • Manage or conduct development and UAT of CSAI programmed outputs • Provide study-specific training to CSAI scientists, project teams, and study sites • Participate in internal and external study meetings and presentations • Support study-specific data committees and meetings • Review TLFs and clinical study reports as needed • Participate in candidate interviews, business development, proposal development, SOP development, departmental training, and process improvement initiatives • 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) • Excellent communication and interpersonal skills to effectively interface with others in a team setting • Excellent organization skills, attention to detail, and a customer service demeanor • 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, the clinical trial process, and clinical research functional departments • Ability to independently manage the CSAI operational function in a global, cross-functional environment • Financial management skills at the functional area project level • Preferred: medical-related degree, RN, OCN, RPH, PharmD, database build experience, on-site monitoring or data review experience, JReview or similar data visualization software, solid and liquid tumor experience, phase I/II/III study experience, and global trials experience

🏖️ Benefits

• Remote work arrangement • Opportunity to work in a global, cross-functional environment • Travel opportunities, including domestic and international travel • Equal Opportunity Employer • Reasonable accommodation available during the application process