Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
Job Title: EDC Project Manager
Location: North Carolina (Raleigh area)
Function: EDC Project Management
Primary Responsibilities:
Serve as the primary subject matter expert (SME) for the provision of support for clinical studies utilizing
Sitero EDC technology by:
- Collaborating across functional segments within Sitero, throughout the project life cycle, to coordinate and execute key project delivery tasks within communicated timelines.
- Facilitating kick off meeting with internal and external study specific operational teams.
- Establishing and leading or contributing to reoccurring study or relationship status meetings.
- Ensuring critical timelines are met by ensuring effective and timely communication occurs between all contributors, both Sitero internal as well as client.
- Reviewing initial requirements and corresponding specifications to ensure study health; providing feedback to appropriate task owners as needed.
- Creating and/or reviewing and approving study specific documents, including but not limited to, study specific project plans, user guides and data and parameter change plans.
- Initiating the coordination of user account creation and subscriptions.
- Assisting with user acceptance testing (UAT), including proactive communication with the client and UAT participants.
- Collaborating with internal training team and customer representatives to create, conduct and maintain study specific training materials and/or events.
- Monitoring EDC issues/resolutions, facilitating meetings, and escalating internally or externally as necessary.
- Securing ownership of the initiation, review, follow-up and close out of study specific quality events including, Notes to File, CAPAs, and Audit responses.
- Maintaining all customer and/or study communication tools.
- Participating 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.
- Reviewing and approving data changes as needed.
- Coordinating implementation of study parameter changes.
- Acting 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.
- Providing urgent study specific support after business hours as needed.
Secondary Responsibilities:
- Maintains Quality Service and Departmental Standards by
o Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
o Assisting in establishing and enforcing departmental standards
- Contributes to team effort by
o Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs) and Working Instructions (WIs).
o Initiating CAPAs when warranted, according to QA procedures.
o Working closely with QA for clarification and documentation of deviations
o Participating in the modification of company SOPs and/or WIs related to EDC Services.
o Suggesting improvements to work processes that enhance the quality of team/client support and improve efficiency.
o Assisting in establishing and enforcing departmental standards.
o Creating, implementing and presenting training materials and tools for both internal and external teams.
o Helping others to achieve success by sharing knowledge, mentoring and training.
o Conducting evaluations/reviews of team member performance as applicable.
o Preparing for and participating in internal/external audits and investigations.
o Participating in the creation of audit response documentation as part of Quality Investigations.
o Continuously improving understanding of business and client processes.
- Keeping knowledge of the EDC space current, including:
o the latest capabilities of Sitero EDC products as new releases are issued
o team best practices for study build and maintenance
o new processes and process adjustments
o Performing other duties as assigned.
- Maintains Technical Knowledge by
o Attending and participating in applicable company-sponsored training.
o Attending and participating in all job-function specific and departmental training.
o Attending product demos and product specific release meetings.
o Initiating self-directed learning of applicable tools, processes, and industry standards.
EDUCATION AND EXPERIENCE REQUIRED:
Education:
- Bachelor’s degree
- 5+ years of experience may be considered in lieu of a degree
Experience:
- 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 skill set:
- 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
Working conditions:
- Travel: 5-20%
- Lifting: 0-25lbs
- Other: Computer work for long periods of time
Compensation$75,000-$85,000
