The eTMF Manager implements and maintains Records Management systems and processes within CDCS and provides direction, leadership and training to ensure effective and efficient operations.
This is an office based position in Warsaw, Poland.
Essential Job Duties:
- Manage the Records Management function within Business Process & Solutions (BP&S).
- Manage and supervise up to 15 direct reports.
- Responsible for ensuring timely artifact verification/reconciliation reports/study transfers by
the Records Management Assistants/ Associates
- Ensures high standards (regulatory, sponsor, Covance) with minimal supervision
- Responsible for ensuring that documents are handled and maintained to the required standards
by maintaining awareness of current regulatory, legal, and other relevant guidelines.
- Oversee storage system for both electronic and existing paper documents that will allow for
identification and retrieval of documents in support of the clinical trial master file.
- Create and maintain Standard Operating Procedures (SOPs) and Work Instructions for job
functions within BP&S for Records Management, discovering and documenting process
- Implement key business processes including clarity over process inputs, outputs and
relationships as it relates to a specific BP&S Records Management.
- Implements the vision and direction as defined by the Director, eTMF by providing
leadership, training, and direction to allow operations to effectively and efficiently manage
the planning and execution of clinical programs for Covance and sponsors for eTMF. *
- Oversees quality within the Records Management Department and associated business
process, looking for improvement opportunities and seeking to translate improvement
opportunities into realities.
- Understand Covance processes for tracking project status and metrics (i.e. EVA, TAQ,
monthly status reports) and provide timely.input on assigned projects as required.
- Responsible for ensuring the compliance of deliverables to applicable regulations, guidance
requirements and client requests.
- Lead awareness efforts and promote/educate employees on Records Management, associated
business quality and compliance.
- Liaises with relevant functional lines regarding responses to inspections.
- Main contact for both project team and sponsors for matters pertaining to a specific TMF. *
- Line management responsibility for the recruitment, training, utilization, development,
coaching, and performance review of assigned personnel.
- Responsible for workload forecasts (resource utilization) for assigned projects and assistance
in the preparation of Time and Cost Estimates for projects.*
- Able to represent aspects ofBP&S Records Management to auditors during client and/or
regulatory inspections as requested.
- Responsible for presenting the TMF study artifacts during audits/inspections and answering
TMF study related questions for auditors/inspectors.
- Ability and willingness to present at internal and external meetings.
- Work with the business, IT and vendor (where applicable) to determine priorities, and
schedule of releases.
- Oversee and manage the strategy execution for the records management components of the
eTMF and the CDS records management needs.
- Any other duties as requested by management