Associate Project Manager

Cardiovascular Research Foundation is hiring an Associate Project Manager to plan and oversee clinical research projects and manage day-to-day clinical trial operations. The role coordinates sponsors and internal teams, oversees project plans, budgets, compliance, reporting, and deliverables, and supports successful trial execution.

Responsibilities

• Leads the development of project related deliverables including the project management plan, overall clinical budget, study timeline, risk management / contingency plan, monitoring plan, communication plan, etc
• Leads interaction with study sponsor and coordinates the various teams within the Foundation according to the agreed upon timelines and budget
• Ensures compliance with Foundation policy, procedures and SOPs, GCP, and local, regional and federal regulations
• Manages the day-to-day operations of multiple clinical trials, including trial start-up, conduct, and closeout activities
• Provides periodic updates, reports, etc. as requested. Manages on – going communication of operation issues and provides key performance indicators to the study team and sponsor
• Participates in project team meetings
• Prepares project plans/guidelines for project implementation
• Maintains a high level of professional expertise through familiarity with clinical literature
• Responsible for Foundation project success through matrix management of all project components including Biometrics, Device/Drug Safety Information, Core Labs, Financial Management, Information Technology, Regulatory and Quality Assurance
• With the assistance of department heads, develops target timeline and prepares project plans
• Ensures the development of trial specific guidance documents are following Foundation Standard Operating Procedures and sponsors’ expectations
• May assist in administration and development of staff training programs in research study conduct and safety, data management, budget constraints in clinical research, quality assurance parameters, and regulatory compliance, including all aspects of FDA and ICH clinical trial requirements
• Performs additional duties as assigned

Preferred

• Previous project management experience, preferred
• Experience at a large Pharmaceutical or Device Company, desirable
• Lead CRA on large global clinical trial, desirable
• Certified Associate Project Management (CAPM) or equivalent, preferred
• Project Management
• Lead CRA Experience
• Global Clinical Trials
• CAPM Certification

Benefits

• Choice of health plans include medical, Dental, and vision coverage
• Company-paid short-term and long-term disability and life insurance
• Health and dependent care flexible spending accounts
• Pre-tax travel expenses through TransitChek program
• 401(k) plan
• Generous paid time off (PTO)
• Ten paid holidays each year
• Flexible hybrid work arrangement requiring a minimum of 2 pre-determined days per week in our mid-town office

Company

• Nonprofit interventional cardiovascular research and education organization
• New York, New York, USA
• http://www.crf.org/
• Founded in 1991
• 51-200 employees

Qualifications

• Bachelor's degree, preferable in medical or life sciences field with 2 or more years of related clinical research experience in a pharmaceutical, medical device, or CRO environment with experience in cardiology preferred; or MBA with 1 year related clinical research experience in a pharmaceutical, medical device, or CRO environment with experience in cardiology
• 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)
• Expert knowledge of GCP/ICH guidelines and FDA regulations
• Comprehensive 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
• Ability to analyze information and make decisions in the presence of conflicting information
• Experience and/or knowledge of all US and OUS regulatory aspects of clinical research including: IDE and IND submissions, adverse event reporting, Good Clinical Practices, Good Documentation
• Previous project management experience, preferred
• Experience at a large Pharmaceutical or Device Company, desirable
• Lead CRA on large global clinical trial, desirable
• Certified Associate Project Management (CAPM) or equivalent, preferred
• Bachelor’s degree, preferable in medical or life sciences field with 2 or more years of related clinical research experience in a pharmaceutical, medical device, or CRO environment with experience in cardiology preferred; or MBA with 1 year related clinical research experience in a pharmaceutical, medical device, or CRO environment with experience in cardiology

Required skills

• Case Report Form (CRF) Analysis, Certified Associate in Project Management (CAPM), Clinical Practice (GCP) and ICH Guidelines, Clinical Research, Drug Development, FDA Regulations, IDE and IND Submissions, Medical Device Development, Microsoft Excel, Microsoft Outlook, Microsoft Project, Microsoft Word

Preferred skills

• Lead CRA on large global clinical trial, desirable, Previous project management experience, preferred

Experience

• 2+ years