Senior Global Clinical Trial Associate (CTA)
A leading Swiss pharmaceutical company are currently looking to hire a Senior Global Clinical Trial Associate (CTA) to be based at their site in Basel. The company employ over 100,000 professionals and have operations in more than 140 countries worldwide. This CTA position is an exciting opportunity to join one of the top 10 global pharmaceutical companies in their Clinical team.
- Support the definition and refinement of the document management strategy for outsourced TMFs, including TMF sponsor oversight activities.
- Oversee the process, system, and tool landscape that supports the management of outsourced TMFs.
- Promote best documentation practice to line functions and provide guidance on document standards for the business functions to support inspection readiness and adherence to Good Documentation Practice:
- Create and/or update SOPs, Working Practices, Guidance Documents, templates, etc. as applicable
- Enforce use of standards and adherence to quality by providing training and support to business functions in cooperation with TMF QC Manager
- Coordinate eDMS Super/Key User community for relevant process area.
- 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 and accurate and compliant document creation; document lifecycle management in close collaboration with system support and business functions.
- Continuously oversee and identify room for improvement for document management processes of outsourced TMFs.
- Lead improvement and innovation initiatives in a matrix organization.
- Act as Business Lead to manage the implementation of a Next Generation DMS in close alignment with IT and business functions:
- Orchestrate business requirements for fully outsourced TMFs 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 TMF training concept(s) and training material:
- Provide input to technical teams for TMF migration, conduct migration testing in particular for TMF sections previously outsourced to CROs;
- Plan, prepare and oversee rollout and change management activities (communication and training).
- Compliance of TMF relevant documentation as well as efficiency of related processes:
- Ensure the timely submission and delivery of high quality TMF documentation enabling regulatory compliance and applications for marketing approval.
Skills and Requirements:
- Minimum Bachelor's Degree in Life Science/Healthcare or equivalent.
- Fluency in English (oral and written), German an advantage.
- Thorough knowledge of clinical Trial Master File process, regulatory requirements, and Good Clinical Practice, in particular for outsourced TMF filing activities.
- At least 5 years in clinical development/clinical operations.
- At least 3 years of working experience with document management systems and excellent understanding of system structures and generic document management functionality.
- Advanced knowledge of clinical documentation and reporting.
- Good understanding of technical processes and PC environment including Microsoft suite of products.
- Knowledge of the national and international data protection legislation.
- Experience with project work or project management in a global, cross-functional, multicultural, and international matrix organisation.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Anna Bigiotti at +44 2038542470 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.