Principal Clinical Scientist

🕒 May 11

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 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-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-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 & resolve 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

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development