Principal/Senior Clinical Data Scientist

Precision Medicine Group (New York, United States); United Kingdom; On-site; GBP 120,000 - 150,000; Full time

Job summary

Precision for Medicine seeks a Principal/Senior Clinical Scientist to lead the clinical science function across Oncology, Rare Diseases, and Autoimmune programs from start-up to database lock. You will provide indication-specific data review, maintain quality, and protect participant safety while collaborating with study teams to ensure timely delivery.

The role requires 8+ years in clinical research, 3+ years Oncology experience, and 1+ year of leadership, with travel up to 25%.

Qualifications

• Bachelor's degree or equivalent in science/health-related discipline.
• Minimum of 8 years of clinical research experience.
• Minimum of 3 years Oncology experience (within past 1.5 years).
• Minimum of 1 year of leadership experience.

Responsibilities

• Lead Clinical Science services per study scope from start through DB lock.
• Perform holistic data review using proprietary and non-proprietary tools with clinical judgment.
• Guide eCRF design, data capture requirements, edit checks, and data review to ensure high-quality data.
• Support RBQM, identify risks, and collaborate with cross-functional teams.
• Collaborate with Medical Monitoring for review of participant data and findings.
• Provide protocol review from a scientific/operational perspective.
• Travel domestically and internationally up to 25%.
• Oversee and maintain study-related plans, trackers, and data review tool specifications.

Skills

Leadership experience

Clinical data review

Oncology experience

Data cleaning

eCRF design

RBQM knowledge

Project management

Communication skills

Microsoft Office

Education

Bachelor's degree in science/health-related field

Medical-related degree preferred

Tools

EDC systems

Microsoft Office Suite

Job description

Position Summary: The Principal/Senior Clinical Scientist is responsible for leading the clinical science function across assigned Oncology, Rare Diseases, and/or Autoimmune clinical development programs, from study start-up through database lock, in alignment with project scope, timelines, and quality expectations. Applicants must have Oncology experience (see Minimum Required Qualifications). In this role, you will provide scientific and indication-specific expertise to support the collection, review, and interpretation of clinical trial data. Working as a key member of Precision for Medicine's cross-functional data review team, you will apply clinical knowledge and scientific insight to identify, evaluate, and resolve data issues, manually (not just programmed exclusion listings outputs) while also leveraging data review tools and platforms, ensuring clinically accurate and high-quality data while protecting participant safety. As a subject matter expert, you will leverage current clinical practice guidelines, standards of care, and disease-area expertise to support complex, scientific and clinical data review and data cleaning activities. You will play an active role in supporting study deliverables and collaborating with internal and external study team members to ensure successful study execution within scope, budget, and timelines.

Key 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).

Qualifications:

Minimum Required:

• 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 3 years Oncology experience, must have been within the past 1.5 years
• Minimum of 1 year of leadership experience

Other Required:

• High Proficiency with Microsoft Office Products (Outlook, Word, Excel, PowerPoint, Teams, OneNote).
• Excellent organization skills, attention to high quality and detail, and a customer service demeanor, communication and interpersonal skills to effectively interface with others in a team setting and written and oral including presentations of data, issues, trends, escalations, etc..
• Professional use of the English language; both written and oral
• Ability to occasionally travel domestically and internationally including overnight stays (up to approximately 25%).

Preferred:

• Medical related degree, RN, OCN, RPH, PharmD, etc.
• Strongly preferred: Experience with Electronic Data Capture (EDC) systems
• Database build experience