Position Summary:
The Principal Clinical Scientist, Clinical Science Analytics & Insights is responsible for & manages the operational clinical science function from study start up through database lock for assigned projects focused on the scientific & indication specific insights into data collection & data visualization outputs to support scientific, clinical-sense data cleaning as part of Precision’s cross-functional data review team. Serves as the subject matter expert in the application of clinical knowledge, guidelines & standards of care to the review of clinical trial data. Serves & contributes to project teams as the CSAI functional lead delivering within scope, time & cost.
Essential functions of the job include but are not limited to:
- 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 & cleaning.
- Support & participate in the development & implementation of process flow for integrated, cross[1]functional, data cleaning for interim &/or final study data deliverables between all applicable departments (e.g., data management, medical, safety, vendors, sponsor, etc.)
- May be responsible to cross-functionally manage the overall data cleaning process internally to support interim &/or final data deliverables (e.g., tier cleaning process/timelines, etc.)
- Manage Medical Monitor review of subject data.
- Provide protocol review from a scientific operational perspective.
- Provide indication-focused, scientific, clinical input & support to Data Management in the development & revision of eCRF specifications, edit checks & completion guidelines &/or other study[1]specific documentation as applicable.
- Provide indication-focused, scientific, clinical input & support to Data Management in the conduct of EDC UAT supporting the CSAI function as applicable.
- Collaborate to support cross-functional departmental communication including internal CSAI communication as applicable 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 & 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 &/or develop & maintain CSAI project related plans, guidelines, & trackers
- Ensure applicable eTMF documentation related to CSAI is maintained as per study project plans & SOPs.
- Support &/or conduct holistic &/or aggregate scientific, clinical sense data review based on defined manual Clinical Data Review Guidelines using various programmed outputs including but not limited to Smart Patient Profiles™, Smart All-Patient-Data Workbook, listings, quality metrics &/or graphs.
- Oversee &/or issue & resole queries in various EDC systems.
- Review &/or provide routine status updates on CSAI data review findings & escalate issues as appropriate.
- Manage &/or conduct the development & associated User Acceptance Testing (UAT) of CSAI programmed output(s)
- Provide study-specific training for CSAI Scientists, project teams &/or study sites based on review findings.
- Participate in internal & external study-specific team meetings &/or presentations as applicable including facilitating CSAI meetings or topics.
- May support study-specific data related committees &/or meetings (e.g., safety review committee)
- May conduct review of Table, Figure & Listings (TLFs) &/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 & client presentations as applicable.
- Serve as an ambassador to promote Precision’s high quality & ethical image in accordance with the company Core Values
- May develop &/or review of SOPs.
- May develop &/or present departmental trainings.
- Contribute to & support company & CSAI process improvement initiatives.
- Performs other duties as assigned by management.
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 & 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
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.
- 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
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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.
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