Senior Project Manager, eCOA Implementation

IQVIA Argentina; Wayne (NJ); On-site; USD 88,000 - 220,000; Full time

Job summary

IQVIA is seeking a project manager to validate scope, plan and schedule moderately complex eCOA projects. You will lead internal teams, coordinate stakeholders, ensure quality and compliance, and provide updates to sponsors. International travel is required.

The role requires a Bachelor's degree, PMP/PRINCE II is a plus, and strong English communication. Prior clinical research experience and knowledge of EDC, eCOA, IWRS are highly desirable.

Qualifications

• Bachelor Degree or equivalent.
• PMP / PRINCE II certification is a plus.
• Experience in project management, ideally in clinical research.
• Experience with clinical research environment and GCP principles.
• Strong leadership and communication skills.
• Fluency in English (verbal and written).
• Knowledge of software development and clinical technologies.

Responsibilities

• Manage day to day implementation of eCOA projects.
• Lead internal staff to support customer projects and internal service projects.
• Define and monitor project scope, budget, timelines, resources and deliverables.
• Ensure adherence to quality standards and client policies.
• Communicate with customers to identify needs and propose solutions.
• Provide regular updates to Sponsor and IQVIA upper management.
• Manage vendor relationships and project risks.

Skills

PMP/PRINCE II

Leadership

English fluency

Problem-solving

Communication

Education

Bachelor’s degree or equivalent

Tools

EDC

eCOA

IWRS

Microsoft Office

Job description

Job Overview

Validates the project scope, plans and schedules for moderately complex projects; adheres to metrics for project success and begins to suggest appropriate metrics; provides input to and applies standards (e.g. delivery process, roles and responsibilities, operational norms, compliance).

Responsibility

• Manage day to day implementation of eCOA projects
• Manage internal staff to support customer projects and manage internal service projects
• Define and monitor project scope, budget, timelines, resources, quality and deliverables for the full project life cycle
• Ensure the project team adheres to high quality service and all applicable corporate and client policies and standards
• Regularly review project contract terms and conditions, and project plan to ensure that all assumptions are still valid
• Work in close collaboration with the internal or external project stakeholders to achieve the study goals
• Establish strong customer relationships and seek opportunities to increase customer satisfaction and deepen relationships
• Communicate effectively with customers to identify needs and propose solutions
• Keep customers well informed on status of internal service efforts and serves as liaison between internal staff and customer
• Provide technical direction for the development, design, and systems integration for customer engagements
• Responsible for managing the development, review and approval of project related study documentation during throughout the full life cycle of the project implementation
• Provide regular updates and reports to Sponsor and IQVIA upper management
• Conduct regular status meetings, reviewing project schedule, risks, issues and outstanding action items
• Implement and monitor a risk management plan at the project level (raise to program level, as necessary)
• Implement corrective actions as needed to maintain project performance. Identifies opportunities for improving and streamlining projects
• Manage vendor relationship and tasks
• Manages the Lessons Learned process throughout the project lifecycle
• Communicate customer requirements to the product management teams, advocate on the customer’s behalf, and communicate the status of enhancement requests to customers
• Manage project team members across multiple locations and time zones
• International Travel required as needed

Education, skills and experience required

• Bachelor Degree or equivalent
• A thorough understanding of Project Management principles - PMP / PRINCE II certification is a plus
• In-depth project management experience ideally within clinical research
• Experience and understanding of the clinical research environment and GCP principles
• Strong leadership, diplomatic and motivational skills
• Open, transparent and excellent communication skills, fluency in English both verbal and written
• Proven ability to work creatively and analytically in a problem-solving environment
• Excellent in planning, organizing and monitoring
• Self-motivated, decisive, with the ability to adapt to change and competing demands
• Able to communicate and deal effectively with all levels of the organization Confident and comfortable with public speaking in front of a large and diversified audience. Ability to adjust presentation material for differing audience
• Solid technical background, with understanding or hands-on experience in software development and clinical technologies (EDC, eCOA, IWRS etc.)
• Strong working knowledge of Microsoft Office tools

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $88,100.00 - $220,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.