Serve as the primary subject matter expert (SME) for the provision of support for clinical studies utilizing Bioclinica RTSM technology by:
Collaborating across functional segments within Bioclinica, 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 BioClinica 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 RTSM 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 RTSM 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 Bioclinica RTSM tools and processes to internal colleagues and external customer representatives.
Providing urgent study specific support after business hours as needed.
Maintains Quality Service and Departmental Standards by
Reading, understanding and adhering to organizational Standard Operating Procedures ("SOP")
Assisting in establishing and enforcing departmental standards
Contributes to team effort by
Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs) and Working Instructions (WIs).
Initiating CAPAs when warranted, according to QA procedures.
Working closely with QA for clarification and documentation of deviations
Participating in the modification of company SOPs and/or WIs related to RTSM Services.
Suggesting improvements to work processes that enhance the quality of team/client support and improve efficiency.
Assisting in establishing and enforcing departmental standards.
Creating, implementing and presenting training materials and tools for both internal and external teams.
Helping others to achieve success by sharing knowledge, mentoring and training.
Conducting evaluations/reviews of team member performance as applicable.
Preparing for and participating in internal/external audits and investigations.
Participating in the creation ofaudit response documentation as part of Quality Investigations.
Continuously improving understanding of business and client processes.
Keeping knowledge of the RTSM space current, including:
the latest capabilities of BioClinica RTSM products as new releases are issued
team best practices for study build and maintenance
new processes and process adjustments
Performing other duties as assigned.
Maintains Technical Knowledge by
Attending and participating in applicable company-sponsored training.
Attending and participating in all job-function specific and departmental training.
Attending product demos and product specific release meetings.
Initiating self-directed learning of applicable tools, processes, and industry standards.
5+ years of experience may be considered in lieu of a degree
2-3 years of experience in a similar role 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
Other: Computer work for long periods of time
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.