Beschreibung
JOB EW2626
Title: Senior Global Clinical Trial Associate (CTA)/Expert Clinical Manager (CM) (Ref.Nr. EW2626)
BRINE SA has been placing top IT specialists at well-known customers for over 30 years. In doing so, we focus on performance, competence, experience and partnerships.
Department: Clinical Document Governance and Management, GDO
Reports to: Head eDMS Center of Excellence & Regulatory Readiness
Job Purpose:
Be responsible for efficient and appropriate management of GxP relevant clinical documents from creation through archival in compliance with applicable internal and external requirements for a defined business process area or project (eg TMF; Regulatory Submission Documents, etc.).
Major Accountabilities:
- Support the definition and refinement of the document management strategy for Documentation within a defined area of Clinical Development.
- Design and/or oversee the process, system and tool landscape that supports the management GCP relevant documentation within a defined business process area. Manage system and/or process Implementation in collaboration with Business and IT Functions.
- Act as Business Analyst/Lead to manage the implementation of Document Management Related Applications.
- Support definition and orchestrate business requirements across NVS and identify achievable business benefits
- Coordinate and participate in system testing activities such as User Acceptance and Performance Qualification Testing to ensure business benefits are reflected
- Support the design of training concept(s) and training material
- Provide input to technical teams for migration and support migration testing
- Plan, prepare and oversee rollout and change management activities (communication and training)
- Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs
- May act as Business Administrator in the electronic Document Management System (eDMS) ensuring appropriate user access restriction, accurate &compliant document creation and document life cycle management in close collaboration with sys-tem support and business functions.
- May act as Business System Owner or deputy for an eDMS or eDMS-related software application.
The above responsibilities are to a large extent based on interdisciplinary topics and require the employee to liaise, cooperate with and coordinate numerous related functions such as internal Clinical Operations functions, CRO representatives, IT.
Job Dimensions:
Compliance of GCP relevant documentation as well as efficiency of related processes:
- Timely submission, delivery of high quality TMF documentation enabling regulatory compliance and applications for marketing approval.
- External satisfaction, acceptability of clinical documentation by Health Authorities.
- Efficient use of resources through operational effectiveness of document management and archiving
- External reputation of NVS clinical documentation, with Health Authorities and in the document management and archiving community in general
Education:
Minimum Bachelor's degree in life science/healthcare or equivalent
Experience:
Thorough knowledge of clinical document management processes
Advanced knowledge of clinical documentation best practice guidelines & principles (good documentation practice, data integrity)
3-5 years in clinical development/clinical operations or similar business area
2-3 years working experience with document management systems and excellent understanding of system structures and generic document management functionality
Good understanding of technical processes and PC environment including Microsoft Suite of products
Advanced ability to work independently
Experience with project work or project management in a global, cross-functional multi-cultural and international Matrix organisation
Excellent communication, organization and tracking skills
Work location: Basel
Start: 01.10.2019
Duration: 1 Year
Workload: 100%
Salary: to be discussed
Language: Fluent English (oral and written), German of advantage
Ref: EW2626
To learn more about this opportunity please send your CV ASAP in Word format to Brine SA
BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:
Financial services sector, especially banks and insurance companies
Pharmaceutical industry
Government and services sectors
BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.
IT - Resources
We offer our top consultants, computer Profi's and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions. BRINE SA is especially distinguished by its renowned characteristic strengths:
Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements.
Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA
Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment.
BRINE SA is ISO 9001:2008 certified since 2014