Penfield Search Partners
Contact: Linda Aronova – email@example.com
Job Description: The Senior Manager, Clinical Systems Oversight position will focus on system oversight tasks surrounding internal Clinical Systems and Operational tools owned within Clinical Operations and ensuring systems and administered in a consistent way both in terms of data access policy implementation and ongoing system operations. The Senior Manager, Clinical Systems Oversight is primary process owner and responsible for driving and performing oversight activities across key systems and trials and optimizing procedures and operational responsibility split among Clinical Operations, IT Service Desk and any 3rd party vendors as applicable.
The Senior Manager, Clinical Systems Oversight will focus on centralizing generic aspects of system oversight across the key systems to ensure a consistent and relevant workflow given the system classification and associated risk, while in compliance with corporate policies and local guidance within the department.
The Senior Manager, Clinical Systems Oversight will frequently coordinate with System Owner(s), user community (e.g., Clinical Management Teams), IT service Desk, system Vendor(s) as applicable per process improvement activities, understanding of platform/system functionality and normal daily operations.
The Senior Manager, Clinical Systems Oversight will be responsible for ensuring vendor systems applicable to clinical operations are validated by the vendor and adhere to the GxP guidelines. Furthermore, this position will ensure that documentation that has been produced has been reviewed and adheres to the principles set out by the various governing agencies.
The Senior Manager, Clinical Systems Oversight will participate in various working groups within and across the department. This position will lead the planning and execution of the oversight strategy to ensure the systems track is kept up to date and in a constant state of inspection readiness.
The Senior Manager, Clinical Systems Oversight role will report to the Head of Programming or delegate.
Key responsibilities include:
The overall tasks fall into different categories, and a nonexclusive summary of the tasks is provided below:
Role specific responsibilities and tasks:
- Lead planning and execution of assigned applications/processes/projects (as applicable) within own area (e.g., SOP development, daily operations and surveillance of applications, inspection readiness activities, risk management review/oversight, quality measurement activities, vendor/CRO initiatives)
- Collaborate with cross-functional teams to support development and review of processes/systems.
- Provide oversight to vendor activities within area (e.g., system implementation, process definition)
- Lead/Assist in assigned departmental optimization projects, setup, and lead workshops
Proactively guide and collaborate with cross-functional teams as a subject matter expert
Ensure oversight is performed in compliance with applicable policies and any system specific SOPs.
- Ensure periodic reviews are harmonized, centralized, and bundled in order to minimize iterations and impact towards the user community (e.g., CMTs) and approver roles (e.g., trial managers, line managers)
- Ensure establishment, operation and improvement off oversight tools/dashboards supporting the monitoring status, lineage, traceability, and reporting of users access request when both granting and removing access, plus overall compliance for inspection readiness.
- Ensure compliance with system specific access model criteria with regards to the type of access every user gets (e.g., admins, super users, normal users) and the scope (portfolio, program, trial level access)
- Optimize and integrate associated processes per user administration workflows in collaboration with stakeholders (e.g., request, pre-requisites: trial allocation, training, SOP R&U, approval, implementation by IT, confirmation and initial guidance for access).
- Apply best practice criteria depending on GxP requirements and associated risk (e.g., segregation of duties for access control by outsourcing IT Service Desk versus self-service administration in LoB)
- Create and maintain process flows at process and task level
Train and guide organization on user administration procedure and workflow from business user perspective and technical angle towards peers in the workflow.
- Establish SLA for user administration timelines and ensure procedures to allow for sufficient compliance with targets defined and approved by System Owner(s).
- Tracking of user administration incidents or significant breaches of SLAs for a quality mgmt. and continuous improvement perspective.
- Ensure vendor systems are validated per agreements made and vendor.
- Ensure documentation of vendor system access summarizes, privileges and frequency are produced and stored.
- Work closely with the various vendors has contracts with to ensure inspection-readiness items are up to date and reviewed regularly.
- Prepare and participate in audits and inspections.
- Identify potential trends or issues and propose long-term strategies for quality improvement or issue resolution
- Leads due diligence activities, if applicable
- Lead/contribute with knowledge sharing within the department
- Leads/Participate in writing guidelines, processes and SOPs related to statistics, programming and visualizations
- Lead and participate in cross-functional working groups/projects/task forces
- Lead/Participate in review and QC of various documentation/data
- Lead/Support estimating of resources for various tasks, if applicable
- Proactively attend relevant department activities
- The Employee shall render such other related services and duties as may be assigned to him/her from time to time by his/her supervisor.
Requirements – what you must have
- Bachelor’s degree in science (or equivalent qualification) with at least 7 years of direct experience in clinical systems oversight/administration/management in the pharmaceutical industry
- At least 3 years of experience in planning and execution of the oversight strategy to ensure the systems track is kept up to date and in a constant state of regulatory authority inspection readiness
- At least 4 years of experience in clinical systems vendor partnership and oversight
Working knowledge of various programming languages is a plus (one or more of these – C++, Python, Java, and AWS)
- Experience working in a global context
Proficient in both written and spoken English
Oncology and regulatory submission experience a plus
- Expert-level competencies within the following areas:
- Systematic and organized
- Clinical development including ICH-GCP
- Strong problem solving and decision making
- Excellent communication skills and able to communicate scientific information in clear and concise manner Quality mindset
- Excellent presentation skills and development of presentation materials (i.e., PowerPoint, Visio, etc.)
- Process development Highly proactive, flexible, adaptable, responsible, and accountable
Analytical and ability to interpret and present clinical data and other complex information
This role can be located in Princeton, NJ USA