Associate Project Manager – Research

Associate Project Manager – Research

Requirements

• Bachelor’s degree, preferable in medical or life sciences field with 1-2 years of related clinical research experience in a pharmaceutical, medical device, or CRO environment with experience in cardiology preferred
• Previous project management experience, preferred
• Proficient with Microsoft Outlook, Word, MS Project and Excel
• Ability to analyze information and solve problems relating to information gleaned from Case Report Forms (CRFs)
• Knowledge of GCP/ICH guidelines and FDA regulations
• Understanding of drug development and medical device process
• Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike. Ability to verbally communicate effectively with department heads, medical leadership and other team members
• Ability to multi-task and interface with users who are working under deadlines. Ability to set priorities with excellent time management skills. Ability to accurately project time to complete tasks and communicate this information effectively to project teams. Must have the flexibility and willingness to occasionally work evenings and weekends in order to meet research trial deadlines
• Experience and/or knowledge of US and OUS regulatory aspects of clinical research including IDE and IND submissions, adverse event reporting, Good Clinical Practices, Good Documentation

Responsibilities

• Supports day-to-day operations of multiple clinical trials, including trial start-up, conduct, and closeout activities
• Supports the development of project related deliverables including the project management plan, overall budget, study timeline, risk management / contingency plan, monitoring plan, communication plan, etc.
• Perform administrative tasks such as organizing and scheduling meetings, training and retreats, including preparing agendas and managing logistics. Additionally, facilitate urgent day-to-day communications with clinical sites
• Supports the development of trial specific guidance documents that align with Cleerly’s and sponsors’ expectations
• Participates in project team meetings
• Ensures compliance with Research Core Lab policy, procedures and SOPs, GCP, and local, regional and federal regulations
• Maintains a high level of professional expertise through familiarity with clinical literature
• Performs additional duties as assigned

Preferred Qualifications

• Previous project management experience, preferred
• Experience in cardiology preferred