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Clinical Process Excellence Manager - Belgium
Keyrus Biopharma (company)
Posted on : 23 May 2017
We are looking for a Clinical Process Excellence Manager to support the Clinical Process Excellence team for one of our Pharma clients.
The Clinical Process Excellence Manager coordinates and supports process improvements within the Product Capability Framework enabling the successful accomplishment of business objectives.
Role and main tasks:
- Supports implementation and day-to-day management of key process from the Clinical Delivery program (Concept Protocol, Protocol, Informed Consent Form, Investigator Brochure, Clinical Study Report, eTMF, CTRS, Publications, Briefing Documents and Clinical regulatory documents)
- Ensures that improvement initiatives fit with department & overall Client's strategy
- Supports the Head of Process Management in defining and implementing 1st level quality controls for Clinical Delivery Process
- Interfaces with Global Operational Excellence team, giving visibility to clinical process improvement initiatives and sharing Global Operational Excellence learning, key experience and know-how with department management
- Monitors new legislation, guidelines and the Client's Corporate Standards and assess impact of these changes on current processes and future requirements
- Ensure delivery of benefits from initiatives as defined in project initiation forms
- Support or facilitate specific clinical process improvement initiatives that have a global impact and will deliver significant benefits across the department
- Support routine inspections and audits to ensure follow up of findings, provide compliance advice in line with ICH-GCP.
- Support deployment of Total Quality Control mindset in the Clinical Operations department to:
- Support effective communication on the process improvement program
- Support enhancing a culture of TQC to do things simpler, smarter, quicker and in a robust, reproducible way
- Support development of Do it Right first time culture within 1st level controls
- Analyze and improve key interfaces
Training and Knowledge Management:
- Support effective roll-out and implementation of initiatives (including training) across all impacted departments for the initiatives that he/she is driving
- Support creation/ongoing updates of General & Function specific training modules
Process Document Simplification and Update:
- Support simplification, update of all Process documents for the capability area that he/she is responsible
- Support tracking of all process documents (SOPs, Guidance, Templates, Forms, Guidelines) for the capability area
- Support timely follow-up of process document updates and interactions with the business
- Scientific degree
- Fundamental understanding of ICH/GCP guidelines and other applicable regulations
- Ideally 8+ 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.