eCOA Manager, Clinical Assessment Technologies

Requisition Number: 7671

Position Title: eCOA Manager, Clinical Assessment Technologies Operations

External Description:

Who we are

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.

Our talented team of 3,000+ professionals spans 60+ countries. We are united in a cause with our customers to improve the lives of patients through new and innovative therapies.   

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 eCOA Manager does at Worldwide

  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.
 
What you will do:
Tasks may include but are not limited to:

• Serve as the main contact for the eCOA vendor, Sponsor, and Worldwide study team members
• Manage vendor deliverables and timelines, as they relate to study assessments
• Negotiate with eCOA vendor and sponsor regarding eCOA scope of work (SOW)
• Review and identify study trends and proactively work with eCOA vendors and the study team to address study-specific requirements
• Conduct risk assessments to study due to vendor deliverable delays, availability of materials, equipment, and translations, and related concerns
• Communicate study risks to the study team and Sponsor in a timely manner
• 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
• Facilitate collaboration between eCOA processes and DM data transfer requirements, eCRF build, and related needs
• Facilitate collaboration between eCOA vendor mapping specifications and DM and Biostatistics
• Participate in budget discussions, including Work Orders, Change Order, and related inputs
• Coordinate and obtain sponsor approval for all vendor-related costs and document/plan versions
• Responsible for reviewing and communicating with vendors regarding system change control, closeout, and database lock activities
• Collaborate with the Worldwide study team to manage eCOA study timelines
• Organize and maintain CAT project files, study mailboxes, documents, SharePoint/portal, and designated folders
• Develop eCOA-specific Launch slides with CAT counterparts
• Organize, arrange, and lead eCOA-related meetings with vendors, including Kick Off Meetings, project build meetings, and maintenance meetings
• Liaise, review, and provide input to all eCOA plans and content
• Oversee and participate in User Acceptance Testing activities
• Protocol consultation specific to eCOA
• Responsible for eCOA requirements gathering

Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
  
What you bring to the role

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

 Your experience

• Bachelor’s degree, in Life Science preferred
• Minimum two years of experience working in eCOA and clinical trials
• Minimum two years of experience in project management
• The individual must demonstrate a strong ability to lead, understand policies and procedures, financial and leadership principles, possess excellent time management and project management skills, and communicate effectively.  
• Demonstrable knowledge of operational aspects regarding Phase I-IV clinical research trials
•  Knowledge of SOPs and ICH/GCP/regulatory guidelines
• Competency in working with data and numbers
• 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 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. 

To view our other roles, check out our careers page at www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

 

City:

State:

Employment Type: Regular

Community / Marketing Title: eCOA Manager, Clinical Assessment Technologies

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong:

CountryEEOText_Description: 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 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. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.