Principal Clinical Scientist

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Act as the functional lead for the implementation of CSAI services according to the study scope of work (SOW) within assigned project teams.

• Serve as a resource for project teams concerning scientific data capture, review, and cleaning.

• Assist in the creation and execution of process flows for integrated, cross-functional data cleaning related to interim and/or final study data deliverables across all relevant departments (e.g., data management, medical, safety, vendors, sponsors, etc.).

• May take responsibility for managing the overall internal data cleaning process to support interim and/or final data deliverables (e.g., tier cleaning processes/timelines, etc.).

• Oversee Medical Monitor reviews of subject data.

• Provide protocol evaluations from a scientific operational viewpoint.

• Offer indication-focused scientific and clinical input to Data Management in the development and revision of eCRF specifications, edit checks, completion guidelines, and/or study-specific documentation as applicable.

• Provide indication-focused scientific and clinical support to Data Management during EDC UAT for the CSAI function as appropriate.

• Collaborate to enhance cross-departmental communication, including internal CSAI communication regarding data capture, review trends, EDC updates, and CSAI programming needs.

• Assist in identifying study risks and managing the resolution of any CSAI study-specific shortcomings.

• Support Project and Financial Management with monthly invoicing and variance management for the CSAI budget.

• Collaborate with CSAI management to ensure that resource requirements are adequately addressed in response to changes in scope of work.

• Oversee and/or establish and maintain CSAI project-related plans, guidelines, and trackers.

• Ensure that relevant eTMF documentation concerning CSAI is maintained according to study project plans and SOPs.

• Support and/or conduct comprehensive and/or aggregate scientific and clinical data reviews following 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, and/or graphs.

• Oversee and/or issue and resolve queries in various EDC systems.

• Review and/or provide regular status updates on CSAI data review findings and escalate issues as necessary.

• Manage and/or conduct the development and associated User Acceptance Testing (UAT) of CSAI programmed output(s).

• Deliver 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 appropriate, including facilitating CSAI meetings or topics.

• May support study-specific data-related committees and/or meetings (e.g., safety review committee).

• May review Tables, Figures, and Listings (TLFs) and/or clinical study reports (CSRs).

• May take part in the interview process for potential new CSAI candidates.

• May engage in business development activities, including proposal development and client presentations as appropriate.

• Act as an ambassador to uphold Precision’s high-quality and ethical reputation in line with the company Core Values.

• May develop and/or review SOPs.

• May create and/or deliver departmental training sessions.

• Contribute to and support company and CSAI process improvement initiatives.

• Perform additional duties as assigned by management.

⛳️ Requirements

• Bachelor’s degree or an equivalent combination of education and experience in a science or health-related field, along with proficiency in medical terminology.

• A minimum of 8 years of clinical research experience or demonstrated competencies relevant to this role.

• At least 1 year of leadership experience.

• Experience with electronic data capture systems.

• Proficiency in Microsoft Office products (Outlook, Word, Excel, PowerPoint).

• Exceptional communication and interpersonal abilities to effectively collaborate in a team environment.

• Strong organizational skills, attention to detail, and a customer-service-oriented demeanor.

• Professional proficiency in the English language, both written and spoken.

• Willingness to occasionally travel domestically and internationally, including overnight stays.

• Medical-related degree such as RN, OCN, RPH, PharmD, etc. (Preferred).

• Experience with database building (Preferred).

• On-site monitoring and/or data review experience (Preferred).

• Familiarity with data visualization software, such as JReview (Preferred).

• Experience in solid and liquid tumors (Preferred).

• Experience in phase I, II, and III studies (Preferred).

• Experience in global trials (Preferred).

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holiday policies.

• Opportunities for professional development and training.

• Collaborative work environment with a focus on innovation.