Precision for Medicine
Principal Clinical Data Scientist
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Principal Clinical Scientist, Clinical Science Analytics & Insights
Position Summary
The Principal Clinical Scientist, Clinical Science Analytics & Insights is responsible for managing the operational clinical science function from study start-up through database lock for assigned projects. This role focuses on providing scientific and indication-specific insights into data collection and data visualization outputs to support scientific, clinical-sense data cleaning as part of Precision’s cross-functional data review team. The role serves as the subject matter expert in the application of clinical knowledge, guidelines, and standards of care to the review of clinical trial data. The role also contributes to project teams as the CSAI functional lead, ensuring deliverables are met within scope, time, and cost.
Essential Functions
- Serve as the functional lead implementing CSAI services per study scope of work (SOW) on assigned project team(s)
- Serve as a resource for project teams regarding scientific-related data capture, review, and cleaning
- Support and participate in the development and implementation of process flow for integrated, cross-functional, data cleaning for interim and/or final study data deliverables between all applicable departments
- May be responsible for cross-functionally managing the overall data cleaning process internally to support interim and/or final data deliverables
- Manage Medical Monitor review of subject data
- Provide protocol review from a scientific operational perspective
- Provide indication-focused, scientific, clinical input and support to Data Management in the development and revision of eCRF specifications, edit checks, completion guidelines, and/or other study-specific documentation
- Provide indication-focused, scientific, clinical input and support to Data Management in the conduct of EDC UAT supporting the CSAI function
- Collaborate to support cross-functional departmental communication on data capture, review trends, EDC updates, CSAI Programming needs, etc.
- Support the identification of study risks, including the management to correct any CSAI study-specific deficiencies
- Support Project & Financial Management on monthly invoicing and variance management of the CSAI budget
- Collaborate with CSAI management to ensure that CSAI resource needs are adequately addressed due to scope of work changes
- Oversee and/or develop and maintain CSAI project-related plans, guidelines, and trackers
- Ensure applicable eTMF documentation related to CSAI is maintained as per study project plans and SOPs
- Support and/or conduct holistic and/or aggregate scientific, clinical sense data review based on defined manual Clinical Data Review Guidelines using various programmed outputs
- Oversee and/or issue and resolve queries in various EDC systems
- Review and/or provide routine status updates on CSAI data review findings and escalate issues as appropriate
- Manage and/or conduct the development and associated User Acceptance Testing (UAT) of CSAI programmed output(s)
- Provide study-specific training for CSAI Scientists, project teams, and/or study sites based on review findings
- Participate in internal and external study-specific team meetings and/or presentations as applicable, including facilitating CSAI meetings or topics
- May support study-specific data-related committees and/or meetings
- May conduct review of Table, Figure & Listings (TLFs) and/or clinical study reports (CSRs)
- May participate in the interview process of potential new CSAI candidates
- May participate in business development activities including proposal development and client presentations
- Serve as an ambassador to promote Precision’s high-quality and ethical image in accordance with the company Core Values
- May develop and/or review SOPs
- May develop and/or present departmental trainings
- Contribute to and support company and CSAI process improvement initiatives
- Performs other duties as assigned by management
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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 1 year of leadership experience
Other Required:
- 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
Preferred:
- Medical-related degree, RN, OCN, RPH, PharmD, etc.
- Database build experience
- On-site monitoring experience and/or data review experience
- Experience with data visualization software such as JReview
- Experience in solid and liquid tumors
- Experience in phase I, II & III studies
- Experience in global trials
Skills & Competencies
- Demonstrates highly advanced knowledge in oncology and medical terminology with the 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 and keep up to date on medical and oncology standards of care with the ability to self-research and educate
- 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
- High level of integrity from a professional and 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, and conflict management skills with the ability to strategically plan and apply effective risk management
- Exhibits self-motivation with the ability to work remotely while independently leading, supporting, and inspiring excellence
- Demonstrates ability to adjust to multiple demands and shifting priorities
- Results-oriented, accountable, motivated, cooperative, and flexible
- Ability to apply financial management skills at the functional area project level
- Excellent presentation, verbal, and written communication skills
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Privacy Policy
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.
Equal Opportunity Employer
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law.
Reasonable Accommodation
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.
Recruitment Fraud Warning
Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.
Employment Authorization
Candidates must be legally authorized to work in the country of employment without employer sponsorship.
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