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
- On-site experience (nurse, study coordinator, etc.), monitoring, &/or data review experience
- Experience with data visualization platform(s)/software(s) as data review tools
- Experience in phase I, II & III studies and global studies
Skills & Competencies:
- 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. in a clinical research setting
- Desire to continually learn and keep up to date on medical and indication-specific standards of care with the ability to self-research and educate, results oriented, exhibiting self-motivation and reliably, with the ability to work remotely while independently lead, support and inspire excellence.
- Demonstrates scientific curiosity and an investigative mindset, with the ability to identify atypical data patterns, formulate hypotheses, from a scientific and clinical focus, and drive appropriate follow-up actions.
- Working knowledge of FDA & ICH-GCP, relevant SOPs & regulatory guidance with a well-rounded knowledge of the entire clinical trial process and working understanding of clinical research functional departments.
- Ability to independently manage the Clinical Science operational function in a global, cross-functional environment with awareness of appropriate escalation.
- Excellent time management, negotiation, critical thinking, decision making, listening, analytical & conflict management skills with the ability to strategically plan & apply effective risk management.
- Demonstrates ability to adjust to multiple demands & shifting priorities.
- Demonstrates ability to mentor, coach, and develop junior team members while fostering a collaborative learning environment.
- Ability to apply financial management skills at the functional area project level.
- Excellent presentation, verbal & written communications skill
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