Principal Clinical Scientist

🕒 May 11

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• 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.

🎯 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 • Medical related degree, RN, OCN, RPH, PharmD, etc. (Preferred) • Database build experience (Preferred) • On-site monitoring experience &/or data review experience (Preferred) • Experience with data visualization software such as JReview (Preferred) • Experience in solid & liquid tumors (Preferred) • Experience in phase I, II & III studies (Preferred) • Experience in global trials (Preferred)