Clinical Scientific Liaison – MD or Pharmacist, 5 years experience, Biotech/Pharma, Oncology

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

📋 Description

• Provide oversight for site management, clinical monitoring, and central monitoring deliverables with a focus on patient safety, compliance with protocols/GCP/regulatory requirements, and data integrity.

• Manage site interactions from activation to closeout, which includes recruitment, investigator payments, and related activities.

• Identify risks in clinical trial management and propose or implement mitigation strategies.

• Review the study scope, budget, and protocol content; ensure that clinical project teams are aware of contractual obligations and parameters.

• Escalate any risks that may impact timelines, quality, budget, or contracted scope.

• Participate in and present at key meetings, including Kick Off Meetings.

• Act as an escalation point for investigator site staff and interact with principal investigators and site personnel.

• Collaborate with Study Start Up, Patient Recruitment, Data Management, and other functional leaders to achieve study milestones.

• Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan.

• Ensure that CTMS, dashboards, and other systems are properly configured and accessible; oversee User Acceptance Testing (UAT) and audit-trail reviews.

• Coordinate protocol-specific and systems training for study teams.

• Oversee the resourcing of CRAs and Central Monitors, manage site assignments, and address conduct and delivery risks.

• Ensure the quality and visibility of clinical monitoring, central monitoring, and site management deliverables.

• Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS, and central monitoring dashboards.

• Ensure team compliance with monitoring strategies, CMP/SMP, and risk management plans.

• Review site and central monitoring documentation to ensure timely revisions, approvals, and deliveries.

• Provide status updates on clinical deliverables and risks to clients, project management, and leadership.

• Resolve barriers in protocol execution and site management.

• Support inspection readiness, corrective action plans, data cuts, and database lock deadlines.

• Oversee CRAs and Central Monitors, assess compliance, and identify emerging risks.

• Provide performance feedback to staff and coach or mentor CTMs.

• Coordinate clinical activities for larger, more complex trials or portfolios when assigned.

⛳️ Requirements

• Bachelor’s degree or RN in a related field, or a combination of education, training, and experience equivalent to this.

• A minimum of 5 years of experience in the biotech/pharma industry, ideally encompassing clinical monitoring, clinical science, and/or medical monitoring.

• Oncology experience is mandatory.

• Proven ability to lead and align teams towards achieving project milestones.

• Ability to work effectively in an international environment.

• Proficiency in site management and clinical or central monitoring.

• Preferred experience with risk-based monitoring methodologies.

• Understanding of financial principles related to clinical trial management and budget oversight.

• Familiarity with Good Clinical Practice/ICH Guidelines and relevant regulatory requirements.

• Adept computer skills.

• Strong conflict resolution abilities.

• Capability to apply problem-solving techniques to navigate complex issues with a risk-management approach.

• Critical-thinking skills to identify issues, ascertain causes, and determine suitable solutions.

• Moderate travel may be necessary, estimated at around 20%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Comprehensive training in technical and therapeutic areas.

• Peer recognition and a total rewards program.

• An inclusive workplace culture.

• Access to extensive resources, including emerging technologies, data, and knowledge sharing.

• Opportunities for diverse career paths and professional growth.