Senior Project Manager, eCOA Implementation

Relha LLC; Durham, Northern (NC, KY); Hybrid; USD 88,000 - 220,000; Full time

Job summary

Relha LLC is seeking a Senior Project Manager to lead the end-to-end delivery of eCOA projects for internal and external clients. The role emphasizes strong leadership, stakeholder collaboration, and adherence to clinical research standards.

The candidate should have a Bachelor degree or equivalent, plus PMP/PRINCE II is a plus, and proven experience in clinical environments with GCP knowledge. International travel may be required.

Qualifications

• Bachelor Degree or equivalent.
• PMP / PRINCE II certification is a plus.
• Experience in clinical research and GCP principles.
• Strong leadership, diplomatic and motivational skills.
• Excellent communication and public speaking abilities.

Responsibilities

• Manage day to day implementation of eCOA 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 policies and standards.
• Review project contracts and plans to validate assumptions.
• Collaborate with stakeholders to achieve study goals and strengthen customer relationships.
• Provide regular updates to sponsors and upper management.
• Manage vendor relationships and lessons learned process.

Skills

Project management

Leadership

Communication

Public speaking

Problem-solving

English language

Education

Bachelor Degree or equivalent

PMP/PRINCE II certification a plus

Tools

Microsoft Office

Clinical technologies (EDC, eCOA, IWRS)

Software development basics

Job description

Senior Project Manager, eCOA Implementation

We are seeking a Project Manager to manage delivery of eCOA projects to internal and external clients .

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.