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Trial Master File functional coordinator - Belgium
Keyrus Biopharma (company)
Posted on : 02 June 2017
As a Trial Master File (TMF) Functional Coordinator, you will join a team on client's site to work on the management of the electronic Trial Master File.
Role and main tasks:
- Work in close collaboration with the TMF Business System Owner to define the business requirements, to support in the impact analysis of the enhancement requests and alignment between the Client's products, support in writing the test protocols and coordination of its executions.
- Ensure validation aspects where appropriate (develop technical documents and execute test protocols for the project).
- This includes the supervision of the business analysis of the project deliverables sub-parts.
- Ensure proper communication between the business, the support and IT and represent the business need as requested - by providing in depth business analysis including interconnected features and gathering agreement from multiple parties including business and IT on new features to implement.
- Support the business to develop business requirements for each wave of changes.
- Scientific degree
- Fundamental understanding of ICH/GCP guidelines and other applicable regulations
- Ideally 5 years in the Pharmaceutical Industry, with a minimum of 4 years within Clinical or related functions
- Technical writing skills & experience in process simplification an asset
- Change management experience
- Understanding of overall working of the Pharmaceutical Industry
- Good knowledge and understanding of the Human subject research space and activities
- Good knowledge of Clinical Development business, procedures and requirements to successfully deliver clinical studies
- Good communication and adaptability skills
- Good project management skills
- Fluent in English, French is a plus
- Result oriented, naturally driven by customer & performance benchmarking and metrics
- Quality mindset, critical sense, attention to details
- Manages change positively, and sees change as an opportunity to improve processes & tools
- Able to positively communicate more effective ways of working
- Team spirit
- Well organized
- Independent worker
- Quick learner
- Stress resilient
- Motivated and dynamic personality
- Enterprise thinking
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.