Medical Project Coordinator

Life Technologies

Full-time

Miscellaneous Manufacturing

About the position

The position involves assisting in the management and evaluation of medical projects, ensuring compliance and optimal performance throughout the project lifecycle. The role requires collaboration with management and stakeholders to coordinate safety data reviews and resolve issues effectively.

Responsibilities

• Coordinate and review safety data using various tools.
• Identify potential issues and resolve or escalate them as appropriate.
• Review safety data and provide summaries for safety review meetings.
• Assist in creating and reviewing safety and medical management plans.
• Manage routine project implementation, including metrics and budget considerations.
• Monitor data review status and escalate delays or risks to stakeholders.
• Present at business development, client, and investigator meetings.
• Resolve complex problems through in-depth evaluation and offer solutions.
• Serve as the primary point of contact for clinical/data management project teams.
• Assist management in training and mentoring.

Requirements

• Bachelor's degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN.
• Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• 2+ years clinical safety experience (clinical research monitoring, pharmacovigilance, or a combination).
• Knowledge of GCPs for medical oversight of clinical trials and SAE processing.
• Knowledge of drug development and safety reporting.
• Knowledge of safety data trending and coding.
• Working knowledge of biostatistics, data management, and clinical procedures.
• Problem-solving and critical thinking skills.
• Good oral and written communication skills.
• Ability to maintain a positive and professional demeanor in challenging circumstances.