eCOA Manager, Clinical Assessment Technologies Operations - US - Remote

Worldwide Clinical Trials; Durham (NC); Remote; USD 60,000 - 100,000; Full time

Job summary

Join a pioneering team at a global CRO where your role as an eCOA Manager will be pivotal in managing electronic clinical outcome assessments. This remote position offers the chance to collaborate with diverse teams and eCOA vendors, ensuring projects are delivered on time and in compliance with regulatory standards. You'll lead risk assessments, negotiate contracts, and facilitate communication across various functional groups. If you're organized, detail-oriented, and passionate about improving lives through innovative clinical solutions, this is the opportunity for you! Embrace a workplace that values diversity and inclusion while making a real difference in the healthcare landscape.

Qualifications

• 2+ years in eCOA and clinical trials with strong project management skills.
• Bachelor's degree in Life Science preferred for this role.

Responsibilities

• Manage eCOA vendor deliverables and timelines for clinical studies.
• Serve as main contact for eCOA vendor and study team members.

Skills

Project Management

Problem-Solving

Communication Skills

Organizational Skills

Time Management

Interpersonal Skills

Education

Bachelor’s degree in Life Science

Tools

MS-Office (Word, Excel, Teams, PowerPoint)

Adobe

Job description

eCOA Manager, Clinical Assessment Technologies Operations - US - Remote

Apply remote type Remote locations Durham, North Carolina time type Full time posted on Posted 3 Days Ago job requisition id JR100526

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!

SUMMARY:

The eCOA (electronic clinical outcome assessment) Manager has primary responsibility for managing deliverables associated with eCOA vendors for Worldwide and Clinical Assessment Technologies (CAT) studies, including operational oversight of the eCOA vendors, management of eCOA related timelines, contracts, risk mitigation, strategic planning, and liaising with relevant Worldwide functional groups. The eCOA Manager is responsible for ensuring all assigned projects are conducted in a timely fashion and in a manner compliant with SOPs and ICH/GCP/regulatory guidelines.

RESPONSIBILITIES:

1. Serve as main contact for the eCOA vendor, Sponsor, and Worldwide study team members.
2. Manage vendor deliverables and timelines, as they relate to study assessments.
3. Negotiate with eCOA vendor and sponsor regarding eCOA scope of work (SOW).
4. Review and identify study trends and proactively work with eCOA vendor and study team to address study specific requirements.
5. Conduct risk assessments to study due to vendor deliverable delays, availability of materials, equipment, and translations and related concerns.
6. Communicate above risks to study team and Sponsor in a timely manner.
7. Identify and liaise with key study functional leads to support eCOA related processes, including but not limited to: CAT team, Project Management (PM), Clinical Operations, Data Management (DM), and Biostatistics.
8. Facilitate collaboration between eCOA processes and DM data transfer requirements, eCRF build, and related needs.
9. Facilitate collaboration between eCOA vendor mapping specifications and DM and Biostatistics.
10. Participate in budget discussions, including Work Order, Change Order, and related inputs.
11. Coordinate and obtain sponsor approval for all vendor related costs and document/plan versions.
12. Responsible for reviewing and communicating with vendor regarding system change control, closeout, and database lock activities.
13. Collaborate with Worldwide study team to manage eCOA study timelines.
14. Organize and maintain CAT project files, study mailboxes, documents, sharepoint/portal and designated folders.
15. Develop eCOA specific Launch slides with CAT counterparts.
16. Organize, arrange, and lead eCOA related meetings with vendor, including Kick Off Meetings, project build meetings, and maintenance meetings.
17. Liaise, review, and provide input to all eCOA plans and content.
18. Oversee and participate in User Acceptance Testing activities.
19. Protocol consultation specific to eCOA.
20. Responsible for eCOA requirements gathering.
21. Perform other duties as assigned.

OTHER SKILLS AND ABILITIES:

1. Highly organized, detail- and service-oriented.
2. Excellent problem-solving skills.
3. Excellent project management skills.
4. Excellent planning, managing, monitoring, scheduling, and critiquing skills.
5. Excellent at meeting timelines consistently and being able to effectively work under pressure.
6. Continuously open to constructive, developmental feedback.
7. Strong writing and verbal communication skills in order to clearly and concisely present information.
8. Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment.
9. Strong ability to handle multiple tasks and many administrative details in a fast-paced and constantly changing environment.
10. Strong adherence to company policies and procedures.
11. Strong self-motivation skills.
12. Strong ability to work in teams.
13. Excellent proficiency in all MS-Office applications including Microsoft Word, Excel, Teams, Adobe, and PowerPoint.

REQUIREMENTS:

1. Bachelor’s degree, in Life Science preferred.
2. Minimum two years of experience working in eCOA and clinical trials.
3. Minimum two years of experience in project management.
4. The individual must demonstrate a strong ability to lead, understand policies and procedures, financial and leadership principles, possesses excellent time management and project management skills and communicate effectively.
5. Demonstrable knowledge of operational aspects regarding Phase I-IV clinical research trials.
6. Knowledge of SOPs and ICH/GCP/regulatory guidelines.
7. Competency working with data and numbers.
8. Fluency in English (will be required to write, speak, and understand English to conduct day-to-day business).
9. 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.

We love knowing that someone is going to have a better life because of the work we do.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.