Project Manager

Cardiovascular Research Foundation•New York, NY

3h•$85,000 - $90,000•Hybrid

About The Position

This role is subject to a flexible hybrid work arrangement requiring a minimum of 1-2 pre-determined days per week in our mid-town office. SUMMARY The Project Manager plans, organizes, communicates, implements and evaluates team objectives and serves as the point of contact for sponsors. Manages day-to-day operational aspects of the project management department as well as of assigned projects. Works with Cardiovascular Research Foundation “Foundation” sponsors and across Foundation departments / project teams to create and execute project plans and revise them as appropriate to meet changing needs and requirements. Reviews deliverables prepared by the team before passing to management and sponsor. Enforces project standards with the project team. Assumes full responsibility for project accounting. Tracks and reports team hours and project expenses and prepares reports for project teams and management. Manages project forecast and budget. Determines appropriate revenue recognition, ensures timely and accurate invoicing, and monitors receivables for project. Analyzes revenue, expenses, margins, bill rates, utilization, capacity, project profitability, and overall contribution to the Foundation. Ensures the project management department has sufficient tools to carry-out these activities.

Requirements

Preferably, the candidate will have a Bachelor's degree in a medical or life sciences field or be a Registered Nurse (R.N.) with more than 2 years of related clinical research experience in a pharmaceutical or medical device setting. Alternatively, a candidate with an MBA who has 1 year of related clinical research experience in a pharmaceutical or medical device setting will also be considered.
Prior experience in a Clinical Research Organization (CRO) with a focus on cardiology is desirable;
Previous project management experience preferred;
Demonstrable proficiency with contemporary project management software such as Monday.com in addition to Microsoft Suite (Outlook, Word, Excel, and MS Project);
Ability to analyze complex data and make informed decisions based on this data, including the interpretation of Case Report Forms (CRFs));
Solid understanding of current GCP/ICH guidelines, FDA regulations, and any other relevant regulatory changes;
Deep comprehension of the contemporary landscape in 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;

Nice To Haves

Experience at a large Pharmaceutical or Device Company, desirable;
Lead CRA on large global clinical trial, desirable;
Certified Project Manager (CPM) or equivalent, preferred;
Experience with data analytics tools such as PowerBI is desirable;

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;
Achieves timely and efficient conduct of multiple clinical trials from start-up to close-out, ensuring all activities adhere to the stipulated guidelines
Ensures the successful completion of assigned projects on time and within budget, meeting all agreed-upon objectives and delivering expected outcomes;
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;
Delivers trial specific guidance documents aligned with Foundation's Standard Operating Procedures and sponsors' expectations, resulting in efficient trial conduct and minimal procedural deviations;
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;