Job Description
The TMF Solutions Management is responsible for providing oversight to assigned aspects of TMF systems, processes and learning strategies. Supporting the TMF Process Owner and IT, the TMF Solutions Management works with subject matter experts and leaders across all departments to ensure user needs are met and TMF strategies are consistent with the needs of the business, our clients and regulatory expectations. The TMF Solutions Management is the liaison between operations and Corporate Services (e.g. IT, Process and Learning Management, etc.). Assignments mayincludenew process initiatives, clientrequirements,systemconfigurationandvalidation,vendor management, CAPA representation, as well as maintenance and ongoing oversight of existing practices.
Responsabilities:
- Services rendered will adhere to applicable Sponsor SOPs, Wls, policies, local regulatory requirements, etc.
- Participate in analysis, development, testing and implementation of TMF and Document Management technology, including external systems and solutions.
- Develop, maintain and improve process and training courses/material for TMF strategies (e.g. SOPs, system manuals, client specific TMF Specifications, etc.).
- Leadassignedsolutionsfortarget area.
- IdentifyTMFsolutionsandstandardsfor Sponsor teams
- Manage globalprojectsandinitiatives,includingcorporatestrategies,CAPAs, etc.
- Identify TMF process and training gaps throughout the organization; strategize and lead implementation of solutions.
- Collect, review, communicateand correct quality data through dataanalytics tools and processes Identify TMF solutions and standards for key clients.
- Participate in analysis, development, testing and implementation of TMF and Document Management technology, including external systems and solutions
Requirements
- 2-5 years intheindustryworkinginaTMFrelatedareainreplacementofeducation.
- Demonstratedapplicationof processes,systemsand maintenanceof the paperandelectronic Trial Master File.
- Read, write and speak English, fluent in host country language.
- ProficientworkingwithinaMicrosoftOfficeEnvironmentPriorindustryexperienceinaTMF- related field,
- CTMS and eTMF systems experience. Veeva experience is recomended
- Experience with problem solving/solution implementations.
- Prior experience in a leadership role.
- Prior experience leading TMF related functions or projects Experience with change management, trainingandprocessimprovementtechniques.
- Knowledge of ICH/GCP, local regulatory authority and clinical development regulations
- Demonstrates excellent organizational and multi-tasking skills.
- Demonstratesthoroughfollow-upandfollow-thrutoproblemresolution,timelinesand deliverables.
- Demonstrates leadership and delegates appropriately.
- Advanced understanding of processes, systems and maintenance of the paper and electronic Trial Master File.
- Knowledge of change management, training and process improvement methodologies.
- Knowledge of System Development Lifecycles.
- Certification in Project Management, Six Sigma or LEAN.
- Coursework in business issues and management (e.g. operational analysis, organization behavior, budgets,etc.),requiredforexperiencedcandidates.
*Please note This role is not eligible for UK visa sponsorship
Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.
