Clinical Operations Manager – Early Phase Feasibility, Financial

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

📋 Description

• Act as an essential member of the global strategy team, delivering persuasive strategies that enhance commercial initiatives and foster growth.

• Work closely with commercial and operational teams by providing site analytics, feasibility insights, capability evaluations, and country-specific or multi-center strategy considerations.

• Execute fair market value (FMV) assessments for proposals that involve external site partners by utilizing an Excel-based costing tool to create precise FMV reference budgets.

• Produce standardized core budget templates using the Excel-based costing tool and GrantPlan to equip project teams with consistent, data-driven baseline budgets that facilitate effective site negotiations.

• Formulate evidence-based, data-informed clinical trial strategies backed by expert insights and comprehensive analytics.

• Present these strategies through white papers, executive summaries, proposals, bid defenses, feasibility assessments, competitive landscape analyses, and client-facing presentations.

• Utilize data mining and research to uncover trends in trial environments—such as country/site distribution, competition, and historical performance—to bolster strategic recommendations.

• Sustain and enhance the global external site partnership network and relevant Strategy & Planning Study Resourcing databases.

• Contribute to overall departmental objectives and improve daily operational efficiencies, which may involve creating SOPs, job aids, work instructions, templates, checklists, trackers, and forms, including controlled documents.

• The formulation of clinical trial strategies necessitates the development and management of relationships with external clinical investigator site partners globally, requiring close collaboration with administrative, operational, and medical staff at external clinical sites.

• Cultivate and establish relationships with key investigation partners, which may involve governance, site success initiatives, site capability visits, site-specific performance, and issue escalation and resolution.

• Complete additional tasks as assigned by the department manager.

⛳️ Requirements

• Bachelor of Science or a related Science degree from an accredited University/College.

• Practical experience and knowledge of global drug development and clinical trials, including a proven track record in professional presentations.

• Familiarity with Early Clinical Development.

• Understanding of the scientific principles, methods, and processes used to conduct systematic and objective inquiries, including study design, data collection, analysis, interpretation, and reporting of results.

• Strong skills in data mining, analysis, and interpretation to support clinical trial strategies.

• Excellent technical/scientific writing skills and meticulous attention to detail.

• Proficient in critical thinking and problem-solving.

• High degree of professionalism, integrity, and collaborative skills on a global scale.

• Effective communication, planning, and organizational capabilities.

• Proven ability to work independently with minimal supervision.

• Capability to manage multiple priorities and adapt to changing expectations.

• Familiarity with ICH-GCP guidelines and global clinical trial processes, particularly for early-phase studies.

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), SharePoint, and Adobe Acrobat.

• Skilled in utilizing data capture, compilation, and analytics tools.

• Ability to comprehend and leverage various technology platforms.

🏝️ Benefits

• Occasional travel to site locations, both domestically and internationally, up to 10% of the time.

• EEO & Accommodations request.