- Contract Type
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 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
Education / Qualifications
- Bachelor’s (4-year) Degree with a Life Science/Business focus.
- In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 7 years related work experience will be considered.
- Understanding of global drug development and the clinical trial project management process.
- Good understanding of the technology components that support the clinical trial process.
- Working knowledge of ICH/GCP Guidelines, including relevant international requirements/guidelines for the conduct of global clinical development programs.
- Strong analytical and interpersonal skills who can mobilize, grasp complex systems and processes, and design and implement process, system improvements with urgency.
- An understanding of Covance procedures, including Standard Operating Procedures.
- Six Sigma experience desired.
- 3+ years of experience working with clinical trial documentation.
- Understanding of ICH-GCP Guidelines.
- Competent knowledge of Microsoft Office products, web based Applications, and Adobe Acrobat Standard, plus the ability to apply related knowledge regarding scanning and other software programs.
- Excellent interpersonal skills
- Good networking abilities and an ability/willingness to work with individuals globally.
- Good communication, planning and organizational skills.
- Ability to negotiate and liaise with sponsors in a professional manner
- Ability to work independently
- Possesses demonstrated ability to supervise others, either directly or in a project matrix scenario.
- Demonstrated ability to handle multiple competing priorities effectively
- Line Management 1+ Years