Senior RTSM Lead, RTSM Support - United States
Bio Clinica (company)
Bioclinica, the trusted leader in clinical trial management innovation and therapeutic expertise, is looking for intelligent, creative and dedicated professionals to join our growing technology team! We are company that values technical excellence, teamwork and a commitment to success. We employ cutting edge technology to provide our customers with industry leading solutions and are currently seeking to fill the position of Senior RTSM Lead. This position is based out of our Audubon, PA office. Remote candidates will be considered.
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.
- Travel: 5-20%
- Lifting: 0-25lbs
- Other: Computer work for long periods of time
This position description should not be deemed all inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.
- Bachelor’s degree 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
- Ability to lead teams
- SQL and SharePoint knowledge a plus
- 4 or more 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) required
- Proven experience managing team process and knowledge improvement
- Project and resource management experience required