Precision for Medicine - Principal/Senior Clinical Data Scientist

Remote - Poland3w ago

Remote Principal EMEA Clinical Research Cloud Computing Senior Data Scientist Data Scientist Principal Excel Microsoft Office Decision Making Risk Management Coaching

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 & interpersonal skills to effectively interface with others in a team setting • Excellent organization skills, attention to detail & a customer service demeanor • Professional use of the English language; both written & oral • Ability to occasionally travel domestically & internationally including overnight stays • Preferred: • Medical related degree, RN, OCN, RPH, PharmD, etc. • Database build experience • On-site monitoring experience &/or data review experience • Experience with data visualization software such as JReview • Experience in solid & liquid tumors • Experience in phase I, II & III studies • Experience in global trials • Demonstrates highly advanced knowledge in oncology & medical terminology with ability to apply knowledge to clinical trial data including the application of disease assessment criteria, standards of care, grading criteria, etc. • Desire to continually learn & keep up to date on medical & oncology standards of care with the ability to self-research & educate. • Working knowledge of FDA & ICH-GCP, relevant SOPs & regulatory guidance with a well-rounded knowledge of the entire clinical trial process & working understanding of clinical research functional departments • High level of integrity from a professional & ethical perspective • Ability to independently manage the CSAI operational function in a global, cross-functional environment with awareness of appropriate escalation. • Excellent time management, negotiation, critical thinking, decision making, analytical &conflict management skills with the ability to strategically plan & apply effective risk management. • Exhibits self-motivation with the ability to work remotely while independently lead, support & inspire excellence. • Demonstrates ability to adjust to multiple demands & shifting priorities. • Results oriented, accountable, motivated, cooperative, & flexible • Ability to apply financial management skills at the functional area project level. • Excellent presentation, verbal, & written communications skills • Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Responsibilities

• Serve as a functional team lead, implementing Clinical Science services per study scope of work on assigned projects from study start through database lock ensuring delivery of high-quality outcomes within agreed timelines and budgets. • Perform holistic individual participant data review, and aggregate participant data review, utilizing a combination of Precision’s proprietary and non-proprietary data review tools and platforms, while applying clinical and scientific judgment based on therapeutic area and indication specific expertise to support data capture, data review and interpretation, query management, and clinically relevant data cleaning activities. • Serve as the scientific and clinical data subject matter expert for study teams, guiding eCRF design, data capture requirements, edit checks, completion guidelines, EDC UAT, and ongoing clinical data review and cleaning to ensure protocol-compliant, high-quality data as studies progress. • Support Risk Based Quality Management (RBQM), identifying and addressing study risks, trends and issues, while partnering with cross-functional teams participating in the risk review processes and meetings. • Collaborate with Medical Monitoring including oversight of Medical Monitor review of participant data and data review findings. • Provide protocol review from a scientific operational perspective. • Working knowledge of Oncology and clinical research standard criteria (e.g.: CTCAE, ASTCT, RECIST 1.1., Lugano, ICANS, etc.). • Support Project & Financial Management invoicing and out of scope management. • Collaborate with Clinical Science management regarding resource needs. • Oversee &/or develop and maintain Clinical Science project related plans, guidelines, and trackers, programming specifications for data review tools/outputs, etc. • Ensure applicable eTMF documentation related to Clinical Science is maintained accurately. • Participate in internal and external study-specific team meetings &/or presentations as applicable including facilitating, coordinating and managing Medical Data Review Meetings. • Contribute to study-level strategy, data review processes, and continuous improvement initiatives. • Support business development needs (e.g.: bid defense meeting attendance/presentations, etc.). • May conduct review of Table, Figure & Listings (TLFs) &/or clinical study reports (CSRs).