Are you ready to redefine what’s possible, and discover your extraordinary potential at Covance? A career here provides the unique chance to create a lasting impact and difference in our patient’s lives.
Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.
Would you like to manage an experienced team of eTMF professionals who have a mind for innovation and demonstrated success in turning new ideas into reality? This unique opportunity will give you the platform to work within a high energy and collaborative environment using industry leading eTMF technology, as part of our global team. We don’t stand still, we constantly strive for process improvements and leading by example you will be inspirational in setting the tone and pace ensuring our continued success.
Along with access to comprehensive benefits this full time permanent role also offers the flexibility of some home working. Your work will be meaningful, the patient outcomes are real, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you will be empowered to own your career journey with mentoring, training and personalized development planning.
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 foridentification 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 processimprovements.
- 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 providingleadership, training, and direction to allow operations to effectively and efficiently managethe planning and execution of clinical programs for Covance and sponsors for eTMF. *
- Oversees quality within the Records Management Department and associated businessprocess, looking for improvement opportunities and seeking to translate improvementopportunities 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, guidancerequirements and client requests.
- Lead awareness efforts and promote/educate employees on Records Management, associatedbusiness 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 assistancein the preparation of Time and Cost Estimates for projects.*
- Able to represent aspects ofBP&S Records Management to auditors during client and/orregulatory 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