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Cardiovascular Research Foundation · 1 week ago
Project Manager
New York, NY
Full-time
Hybrid
Mid Level
$80K/yr - $90K/yr
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Health Care
Insider Connection @Cardiovascular Research Foundation
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
Manages allocated clinical studies according to timelines and quality standards
Monitors and analyzes project status to ensure successful completion of project parameters, milestones, timetables (i.e., regulatory document, work orders agreement, etc.)
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 that 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
Qualification
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Required
Bachelor’s degree, preferable in medical or life sciences field or R.N. 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;
Previous project management experience preferred;
Experience at a large Pharmaceutical or Device Company, desirable;
Lead CRA on large global clinical trial, desirable;
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 processes;
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;
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 Practices, Medical Device Directive, Clinical Trials Directive, Authorized and Legal Representatives, Ethics Committees and Competent Authorities, desirable;
Preferred
Certified Project Manager (CPM) or equivalent, preferred;
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
Company
Cardiovascular Research Foundation
The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving.
Founded in 1989
51-200 employees
H1B Sponsorship
Cardiovascular Research Foundation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (2)
2022 (2)
2020 (4)
Funding
Current Stage
Growth StageLeadership Team
Donald L. Abrams
Chief Legal Officer
Shawn Ricketts, SHRM-CP
Talent & Engagement Partner
Company data provided by crunchbase
