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About the Role

The Associate Project Manager plans, organizes, communicates, implements, and evaluates team objectives, serving as the point of contact for sponsors. This role manages the day-to-day operational aspects of the project management department and assigned projects, working with sponsors and cross-functional teams to create and execute project plans.

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.
Develops target timeline and prepares project plans with the assistance of department heads.
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.

Requirements

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.
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.
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.

Skills

Microsoft Outlook
Microsoft Word
Microsoft Project
Microsoft Excel
GCP/ICH guidelines
FDA regulations
Drug development process
Medical device process
Communication skills
Writing skills
Time management skills

Location

mid-town office

Work Type

hybrid
flexible

Experience Level

2 or more years of related clinical research experience
1 year related clinical research experience
Previous project management experience
Experience at a large Pharmaceutical or Device Company
Lead CRA on large global clinical trial

Education Level

Bachelor’s degree
MBA
Certified Associate Project Management (CAPM) or equivalent

Salary/Compensations

$68,000 - $73,000 per year

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

About the Company

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

Equal Opportunity

CRF is an equal opportunity employer.