Ref #: 32549

Employment type: Permanent - Full-Time

Location: Belgium

Posted: 03-Nov-2021

Description

The TMF Solutions Manager 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 Manager 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 Manager is the liaison between operations and Corporate Services (e.g. IT, Process and Learning Management, etc.). Assignments may include new process initiatives, client requirements, system configuration and validation, vendor management, CAPA representation, as well as maintenance and ongoing oversight of existing practices.




Key responsibilities:

• Services rendered will adhere to applicable SOPs, WIs, 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.)
• Lead assigned solutions for target area
• Identify TMF solutions and standards for key clients

Advanced Level:
• Manage global projects and initiatives, including corporate strategies, CAPAs, etc
• Identify TMF process and training gaps throughout the organization; strategize and lead implementation of solutions
• Collect, review, communicate and correct quality data through data analytics 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.
• Develop, maintain and improve training courses/material for TMF processes and systems (e.g. SOPs, system manuals, client specific TMF Specifications, etc.)





Required experience and qualifications:

• Academic degree with 1-5 years in the industry working in a TMF related area in replacement of education
• Demonstrated application of processes, systems and maintenance of the paper and electronic Trial Master File
• Read, write and speak English, fluent in host country language a plus (Dutch/French).
• Proficient working within a Microsoft Office Environment Prior industry experience in a TMF-related field
• Experience with problem solving/solution implementations
• Prior experience leading TMF related functions or projects Experience with change management, training and process improvement techniques.
• Knowledge of ICH/GCP, local regulatory authority and clinical development regulations
• Demonstrates excellent organizational and multi-tasking skills
• Demonstrates thorough follow-up and follow-thru to problem resolution, timelines and 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

Advanced Level:
• 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.), required for experienced candidates


Remuneration & other details:

• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical companies and develop an interesting career in the pharmaceutical domain
• Office based in Antwerp region, plus home-based possibilities
• Unlimited permanent contract
• Friendly work atmosphere
• Competitive fringe benefits package (company car + fuel card, insurances, recuperation time, pension, meal-vouchers, eco-cheques, …)




Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.




Interested?
Please submit your CV via www.docsglobal.com, or to ken.falorni@docsglobal.com