Clinical Documents Manager
- Experience Level
A fantastic opportunity has arisen for an individual to join a highly prestigious global pharmaceutical company based in Switzerland, as a Clinical Documents Manager on an initial 9-month contract. This is an opportunity to work for a patient-centric company that focuses on innovative research and development in order to facilitate bringing life-changing treatments to market.
In this role, you will be supporting the Clinical Document Governance and Management department with a focus on Clinical Documentation relevant for Regulatory Submissions.
In this role you will:
- Support the document management strategy for Clinical Documentation relevant for Regulatory Submission, including Clinical Trial Protocols and Clinical Study Reports
- Oversee and/or design the process, system and took landscape that supports the management of GCP relevant documentation
- Manage the implementation of Document Management Related Applications
- Ensure deliverables comply with HA guidelines, Good Clinical Practices and Internal SOPs
- Support the design of training concepts and training material
- Compliance of GCP relevant documentation as well as the efficiency of related processes, including timely submissions, delivery of high-quality TMF documentation enabling regulatory compliance and applications for marketing approval
- Cooperate with and coordinate numerous related functions such as internal Clinical Operation functions and CRO representatives
You will bring to this role:
- Bachelor’s Degree or higher in life science/healthcare or equivalent
- Fluent English (oral and written) with German as an advantage
- Expert knowledge of Clinical Trial Master File process, regulatory requirements and Good Clinical Practice, in particular for outsourced TMF filing activities
- Advanced knowledge of Clinical Documentation and reporting
- Strong experience of the National and International Data Protection Legislation
- Advanced ability to work independently
- Excellent communication, organization and tracking skills
- Experience with project work/management in a global, cross-functional multicultural and international matrix organization
In return you will receive:
- Competitive pay rate
- Immediate start
- The opportunity to work with a global innovative pharmaceutical company with a fantastic culture
- Identification and reward for exceptional accomplishments
- The ability to grow within a compassionate and development orientated organisation
If you have the skills and experience for this opportunity and the ambition to take on this position, please call Katie for further details or email your CV today.
Contact Katie at +44 1273 090743 or Katie.firstname.lastname@example.org. You can also reach our Switzerland office on 0615 880 066.
Katie is a Senior Search Consultant at Haybury Search covering Europe, UK, North America and Asia.
This job advertisement is placed by Haybury AG, Teichgässlein 9. 4058 Basel, Switzerland. In the course of this job offer the selected employee will be employed for hiring of services. All preselected applications will be forwarded to Haybury AG and be processed by Haybury AG according to Swiss law.