Associate eCOA Manager - US - Remote

Worldwide Clinical Trials Co., Ltd.; California (MO); Hybrid; USD 72,000 - 143,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Project Manager for the Clinical Systems Department to oversee eCOA projects from maintenance to decommissioning. You will coordinate timelines, budgets, and stakeholder communications across internal teams and sponsors.

Qualifications include 1 year in eCOA and trials, project management experience, and English fluency. Travel may be required domestically and internationally to support global studies.

Qualifications

• Educated to degree level in a relevant discipline or able to demonstrate equivalent experience.
• Minimum 1 year of experience working in eCOA and clinical trials.
• Minimum 1 year of experience in project management.
• Demonstrable knowledge of operational aspects regarding Phase I-IV clinical research trials.
• Has knowledge of the Software Development Life Cycle (SDLC) and be familiar with eCOA topics.
• Contract Research Organization (CRO) or pharmaceutical experience required.
• Fluency in English (will be required to write, speak, and understand English to conduct day-to-day business).
• The role may require travel domestically and internationally in order to attend key meetings.

Responsibilities

• Provide project management oversight from maintenance to eCOA decommissioning, including oversight and accountability of deliverables and timelines and completion of work to Worldwide SOP standards
• Review and identify study trends and proactively work with eCOA vendor and study team to address study specific requirements
• Communicate information on applicable eCOA project activities to stakeholders, including internal and sponsor study teams.
• Serves as the escalation point of contact for all eCOA assigned study‑related project issues
• Overall accountability for coordination and timely delivery of eCOA project communications including study status reports, meeting agendas and minutes and scheduling project calls
• Responsible for overall eCOA study design review and approving User Requirements Specification (URS) for post go‑live Change in Scope
• Prepare, review and approve site and support materials as well as helpdesk documentation, when required
• Perform financial review and budget management, including review of Change Orders

Skills

Project management

eCOA

Client-facing

English fluency

Budget management

SDLC knowledge

Travel flexibility

Education

Degree in a relevant discipline

Tools

Office software

Job description

Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands‑on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What the Clinical Systemss Department does at Worldwide

Our Clinical Systems Department plays an essential role for the entire organization by ensuring our systems are developed to study specifications, fully integrated, optimally running, and well‑maintained throughout the studies’ lifecycle. The department works closely with industry specific systems such as: IRT, RTSM, EDC, RBQM Opra, ClinSpark, eTMF and CTMS. The department has various roles including client‑facing Project Managers, System and Software Designers, and Implementation and Validation specialists. Each of these areas provides mentorship and training. In working with a variety of systems, the department has a proven record of success for promotions and growth internally.

What you will do

• Provide project management oversight from maintenance to eCOA decommissioning, including oversight and accountability of deliverables and timelines and completion of work to Worldwide SOP standards
• Review and identify study trends and proactively work with eCOA vendor and study team to address study specific requirements
• Communicate information on applicable eCOA project activities to stakeholders, including internal and sponsor study teams.
• Serves as the escalation point of contact for all eCOA assigned study‑related project issues
• Overall accountability for coordination and timely delivery of eCOA project communications including study status reports, meeting agendas and minutes and scheduling project calls
• Responsible for overall eCOA study design review and approving User Requirements Specification (URS) for post go‑live Change in Scope
• Prepare, review and approve site and support materials as well as helpdesk documentation, when required
• Perform financial review and budget management, including review of Change Orders

What you will bring to the role

• Proficient client‑facing skills
• Proficient in the use of common office software
• Self‑motivated individual who can positively contribute to a team environment
• High attention to detail
• Ability to prioritize and handle multiple projects simultaneously
• Flexible and able to use sound independent judgment and take initiative to assess information
• Able to make effective decisions in a fast‑paced, highly dynamic environment
• Able to be creative, adapt to new technologies, concepts and processes, make improvements and solve problems
• Highly organized, detail‑ and service‑oriented
• Excellent project management skills

Your experience

• Educated to degree level in a relevant discipline or able to demonstrate equivalent experience
• Minimum 1 year of experience working in eCOA and clinical trials
• Minimum 1 year of experience in project management
• The individual must demonstrate an ability to lead, understand policies and procedures, financial and leadership principles, possesses excellent time management and project management skills and communicate effectively.
• Demonstrable knowledge of operational aspects regarding Phase I‑IV clinical research trials
• Has knowledge of the Software Development Life Cycle (SDLC) and be familiar with eCOA topics, including eCOA designs and scales
• Contract Research Organization (CRO) or pharmaceutical experience required
• Fluency in English (will be required to write, speak, and understand English to conduct day‑to‑day business)
• The role may require travel domestically and internationally in order to attend key meetings.
• The global nature of the position may also require the incumbent to occasionally manage their time flexibly in order to be responsive to stakeholders in different time zones.

At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates): United States of America - $71,500.00 - $142,500.00 The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage. We love knowing that someone is going to have a better life because of the work we do.

For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn. This is who we are. We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.