Medical Project Coordinator

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

📋 Description

• Coordinate and assess safety data utilizing line listings, company dashboards, and/or visualization tools.

• Analyze data for safety trends, coding consistencies, and potential follow-ups with investigator sites.

• Identify potential challenges and address or escalate them as necessary.

• Examine safety data and provide summaries for safety review meetings.

• Review specified sections of aggregate reports.

• Assist in the creation and evaluation of safety and medical management plans for studies, as needed.

• Ensure that plan processes align with contracted services.

• Aid in managing routine project execution, forecasting, and coordination.

• Analyze metrics and budget considerations.

• Monitor data review progress and notify stakeholders and study leads of any delays or risks.

• Present at business development, client, and investigator meetings as required.

• Engage in strategy and business development discussions.

• Tackle complex issues through thorough evaluation and propose effective solutions.

• Act as the primary contact for clinical/data management project teams when necessary.

• Support management in training and mentoring activities.

⛳️ Requirements

• Bachelor’s degree in nursing or a related Health Sciences field (Physician's Assistant) or a licensed RN.

• Prior experience equivalent to 2+ years.

• Over 2 years of clinical safety experience, including clinical research monitoring, pharmacovigilance, or a blend of both.

• Equivalency may be considered through a combination of relevant education, training, and/or directly related experience.

• Understanding of GCPs for medical oversight of clinical trials and SAE processing.

• Familiarity with drug development and safety reporting.

• Knowledge of safety data trending, including coding practices.

• Proficient understanding of biostatistics, data management, and clinical procedures.

• Strong problem-solving and analytical thinking abilities.

• Excellent oral and written communication skills.

• Keen attention to detail.

• Capacity to work effectively in a collaborative team environment.

• Ability to maintain a positive and professional attitude in challenging situations.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Chance to contribute to scientific excellence and innovative healthcare solutions.