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 in accordance with the study scope of work (SOW) within assigned project team(s).

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

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

• May oversee the overall data cleaning process internally to ensure timely interim and/or final data deliverables (e.g., tier cleaning processes/timelines, etc.).

• Manage the Medical Monitor's review of subject data.

• Conduct protocol reviews from a scientific operational viewpoint.

• Provide indication-focused scientific and clinical input and assistance to Data Management in the creation and revision of eCRF specifications, edit checks, completion guidelines, and/or other study-specific documents as necessary.

• Offer indication-focused scientific and clinical input and support to Data Management during the conduct of EDC UAT, as applicable to the CSAI function.

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

• Aid in identifying study risks and managing the rectification of any CSAI study-specific shortcomings.

• Assist Project and Financial Management with monthly invoicing and variance management of the CSAI budget.

• Work with CSAI management to ensure that resource needs are appropriately addressed due to changes in the scope of work.

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

• Ensure that all relevant eTMF documentation related to CSAI is maintained in accordance with study project plans and SOPs.

• Support and/or conduct comprehensive and/or aggregate scientific and clinical data reviews based on defined manual Clinical Data Review Guidelines utilizing 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 within 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 outputs.

• 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 relevant, including facilitating CSAI meetings or discussions.

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

• May conduct reviews of 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 applicable.

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

• May develop and/or review SOPs.

• May create and/or present departmental training sessions.

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

• Perform other duties as assigned by management.

⛳️ Requirements

• Bachelor’s degree or a comparable combination of education and experience in a science or health-related field, with a solid understanding of medical terminology.

• At least 8 years of experience in clinical research or demonstrated competencies for this role.

• Minimum of 1 year of leadership experience.

• Familiarity with electronic data capture systems.

• Proficient in Microsoft Office Products (Outlook, Word, Excel, PowerPoint).

• Outstanding communication and interpersonal skills to effectively interact with others in a team environment.

• Strong organizational skills, meticulous attention to detail, and a customer service attitude.

• Proficient use of the English language, both written and spoken.

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

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.

• Flexible work arrangements.

• Professional development.