eCOA Project Manager

Resolvit.com - Remote

RESOLVIT

Bringing Solutions That Make Business Better

Join Resolvit as an eCOA Project Manager and be part of a creative, forward-thinking team. Our success at deploying skilled, highly knowledgeable experts has landed us on the Inc. 5000 list of America’s fastest-growing companies four times – and we’re just getting started.

As the eCOA Project Manager, you will be accountable for the client's study specific eCOA solution implementation and ongoing conduct support. You will provide subject matter expertise, lead study specific implementation, and ensure on time delivery and remediation of support issues. You will also lead a cross functional team comprised of Clinical Trial Supply, Global Clinical Operations, Biostatistics, Data Management, vendors, and others as needed to specify, test, implement, and manage study specific eCOA systems. Additionally, you will:

  • Oversee and drive eCOA related timelines and deliverables with eCOA vendor
  • Conduct internal review meetings of eCOA vendor written user specification requirements and integration specifications
  • Plan, facilitate, and lead eCOA study and design review meetings
  • Ensure completion and approval of all eCOA related documentation including specifications
  • Ensure compliance with relevant regulations such as GxPs and ICH E6
  • Study specific primary point of contact for eCOA vendor
  • Provide advice and direction to eCOA implementation team for utilization of vendor eCOA system
  • Serve as subject matter expert on best practices for all aspects of eCOA
  • Act as a central knowledge repository regarding eCOA experiences and share lessons learned across teams
  • Define and complete initial information documents used for requesting a proposed scope of work from eCOA vendor
  • Provide expert input on all eCOA related specification requirements
  • Review user requirement specifications and any other eCOA related specifications to ensure sound implementations and configurations that will meet study specific and the client's program needs
  • Supply advice and expertise on any proposed system changes after launch
  • Deliver expertise to the planning and execution of user acceptance testing
  • Review and approve a schedule of testing that reflects the agreed user requirements specifications
  • Create study specific eCOA test plan
  • Create study specific eCOA test scripts for the sponsor testing team
  • Facilitate UAT by providing support to sponsor testing team and direction to eCOA study implementation team, ensuring that any issues are discussed with the eCOA vendor and that a course of action is agreed upon and documentation is completed appropriately
  • Ensure necessary data exchange (integrations or data transfers) between eCOA and other systems
  • Partner with stakeholders to define instances where data exchange is needed
  • Collaborate with stakeholders to determine data exchange solution
  • Oversee initial and periodic testing to ensure transfers are timely, efficient, and bug-free
  • Provide guidance to the client's study team for vendor implementation of site-initiated data changes
  • Facilitate collection of close out deliverables from eCOA vendor
  • Maintain study specific issue and risk log
  • Document issues and facilitate investigation into root cause, corrective action, and as applicable, preventative action
  • Track study specific risks and remediations
  • Be accountable for study specific eCOA contract, budget, and change orders
  • Support global eCOA
  • Lead in managing and governing eCOA processes at the client
  • Assist with collection and reporting of metrics
  • Suggest improvement to quality procedures and best practices
  • Conduct and create, if necessary, eCOA related trainings for the client's members
  • Foster collaboration among internal stakeholders including, but not limited to, Clinical Trial Supplies, eClinical Technology, Global Clinical Operations (Study and Site Management), Biostatistics, Data Management, Clinical Procedural Documents & Standards, Clinical Quality, Regulatory, and Outsourcing
  • Advise manager of project status and issues as they arise

What You’ll Need to be Successful:

  • 1 to 2 years of experience as an eCOA Project Manager
  • Bachelor’s degree
  • Experience managing complex eCOA solution implementation from kick-off to decommissioning
  • Experience as an eCOA SME to provide guidance on all aspects of eCOA system solution to the sponsor study team
  • Proficiency converting complex technical and business requirements into an understandable UAT test plan and UAT test scripts
  • Experience with clinical systems such as CTMS, IRT, EDC, or other related technology in pharmaceutical/biotechnology industry

Great Additional Skills:

  • Strong data management expertise

Benefits:

At Resolvit, you’ll be given the support you need to grow in your consulting career. In addition to opportunities for advancement, we offer:

  • Medical, dental, and vision insurance
  • Life insurance coverage
  • Long-term and short-term disability coverage
  • 401(k) retirement plan with matching
  • Professional support from our Client & Employee Optimization Specialist

We currently have more than 100 open career opportunities across the country, so be sure to mention the appropriate Job Code with any correspondence!

About Resolvit:

Resolvit is an international technology consulting firm with industry-leading customers in the financial services, high tech, manufacturing, retail, life sciences, and government sectors. Through its partnerships, Resolvit delivers highly impactful, innovative solutions across five core areas: Infrastructure Modernization, Application Development Services, Enterprise Data Management & Analytics, Knowledge & Content Management, and Strategic Staffing.



Posted On: Thursday, May 6, 2021



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