Lead Medical Project Coordinator

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

📋 Description

• Operate autonomously to conduct and/or oversee the initial review of safety data using line listings, company dashboards, and/or various visualization tools.

• Analyze data for safety patterns, coding uniformity, and possible follow-up with investigator sites.

• Proactively detect any potential issues and either resolve or escalate them as necessary.

• Examine safety data and deliver thorough summaries for safety review meetings.

• Initiate and spearhead efforts to enhance existing processes and create new procedures related to medical monitoring and departmental services.

• Function independently as the Project Lead for medical monitoring services when SAE case processing has not been contracted.

• Oversee project implementation, coordination, ongoing maintenance, and closure of assigned studies as needed.

• Act as the primary liaison for clinical project teams on studies and may serve as the alliance-level lead on larger alliance/multi-protocol studies.

• Develop and maintain safety and medical management plans for studies (as applicable) and ensure that the processes outlined in the plan document align with the contract and services requested for studies involving the department, as well as standalone studies (e.g., MM and/or MPC).

• Independently monitor the project's financial status, unit forecasting, actual realization, and team allocations in systems.

• Coordinate staff projections based on contract values and actual hours utilized.

• Escalate any financial and/or operational risks and attend risk management meetings to discuss them.

• Present at business development, client, and investigator meetings and engage in strategy/business development calls.

• Represent studies at risk management meetings.

• Independently assess hours required for out-of-scope work for both the MM and MPC and communicate this information to the finance/study team for contract modifications.

• Attend meetings to discuss and justify the modification requirements.

• Train and mentor new team members.

• Serve as the primary contact for team member inquiries, escalating to management as appropriate.

• May provide feedback on individual performance to the direct line manager.

• Organize and lead meetings with team members to address potential process issues, respond to questions, and brainstorm ideas and solutions.

• Resolve complex problems through thorough analysis of various factors and propose solutions.

⛳️ Requirements

• Bachelor's degree in Nursing or a related Health Sciences field (Physician's Assistant) or hold a valid RN license.

• Prior experience that equips the candidate with the knowledge, skills, and abilities to perform the role (equivalent to 8+ years), including 8+ years of clinical safety experience (clinical research monitoring, pharmacovigilance, or a combination of both).

🏝️ Benefits

• Health and wellbeing support.

• Professional development opportunities.