Associate Project Manager CTC

This role is subject to a flexible hybrid work arrangement requiring a minimum of 1 pre-determined day per week in our mid-town office.

SUMMARY

The Associate 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 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. Full responsibility for project accounting. Tracks and reports team hours and project expenses and prepares reports for project teams and management. Manages project 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.

ESSENTIAL DUTIES AND 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;
• 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.

QUALIFICATIONS

• 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 process;
• Certified Associate Project Management (CAPM) or equivalent, preferred;
• 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;
• Practices, Medical Device Directive, Clinical Trials Directive, Authorized and Legal Representatives, Ethics Committees and Competent Authorities; desirable;
• 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.

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

COMPENSATION
The hiring range for this position is $70,000 - $80,000 per year. The annual salary that will ultimately be offered to the successful candidate will depend on job-related knowledge, education, skills, and experience.

CONTACT INFORMATION

To be considered for this opportunity, please submit your resume.

Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day www.crf.org

CRF is an equal opportunity employer.