EDC Project Manager

4 weeks ago

Raleigh, North Carolina, United States Sitero LLC Full time

Job Title: EDC Project Manager

Location: North Carolina (Raleigh area)

Function: EDC Project Management

Primary Responsibilities:

  • Collaborate across functional segments within Sitero to coordinate and execute key project delivery tasks within communicated timelines.
  • Facilitate kick off meetings with internal and external study specific operational teams.
  • Establish and lead or contribute to recurring study or relationship status meetings.
  • Ensure critical timelines are met by ensuring effective and timely communication occurs between all contributors, both Sitero internal and client.
  • Review initial requirements and corresponding specifications to ensure study health; provide feedback to appropriate task owners as needed.
  • Create and/or review and approve study specific documents, including but not limited to, study specific project plans, user guides, and data and parameter change plans.
  • Initiate the coordination of user account creation and subscriptions.
  • Assist with user acceptance testing (UAT), including proactive communication with the client and UAT participants.
  • Collaborate with internal training team and customer representatives to create, conduct, and maintain study specific training materials and/or events.
  • Monitor EDC issues/resolutions, facilitate meetings, and escalate internally or externally as necessary.
  • Secure ownership of the initiation, review, follow-up, and close out of study specific quality events, including Notes to File, CAPAs, and Audit responses.
  • Maintain all customer and/or study communication tools.
  • Participate in oversight and confirmation of amendments to the EDC system. Activities include but are not limited to reviewing the updated URS and study specific documentation, ensuring appropriate customer approvals are received, and coordinating the UAT of the amendment.
  • Review and approve data changes as needed.
  • Coordinate implementation of study parameter changes.
  • Act as a trusted advisor to the study team and client by providing subject matter expertise of Sitero EDC tools and processes to internal colleagues and external customer representatives.
  • Provide urgent study specific support after business hours as needed.

Secondary Responsibilities:

  • Maintain Quality Service and Departmental Standards by reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs).
  • Assist in establishing and enforcing departmental standards.
  • Contribute to team effort by reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs) and Working Instructions (WIs).
  • Initiate CAPAs when warranted, according to QA procedures.
  • Work closely with QA for clarification and documentation of deviations.
  • Participate in the modification of company SOPs and/or WIs related to EDC Services.
  • Suggest improvements to work processes that enhance the quality of team/client support and improve efficiency.
  • Assist in establishing and enforcing departmental standards.
  • Create, implement, and present training materials and tools for both internal and external teams.
  • Help others to achieve success by sharing knowledge, mentoring, and training.
  • Conduct evaluations/reviews of team member performance as applicable.
  • Prepare for and participate in internal/external audits and investigations.
  • Participate in the creation of audit response documentation as part of Quality Investigations.
  • Continuously improve understanding of business and client processes.

Requirements:

  • Bachelor's degree
  • 5+ years of experience may be considered in lieu of a degree
  • 2-3 years of experience in a similar role with EDC required
  • Proven ability to effectively lead a diverse team throughout the study lifecycle
  • Experience with interactive response technologies, drug supply, randomization strategies, and other similar clinical trials supplies management methods is required
  • Understanding of regulatory requirements related to Clinical Study operations (including GCP, GMP, and GDP) preferred

Additional Skills:

  • Strong computer skills including but not limited to Microsoft Office Suite
  • Ability to work in a team environment
  • Ability to lead small teams
  • Ability to mentor junior team members
  • Strong problem-solving and organizational skills
  • High attention to detail
  • Demonstrated ability to manage time and multiple tasks, effectively prioritize responsibilities, and successfully meet deadlines
  • Excellent oral and written communication skills
  • SQL and SharePoint knowledge a plus

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