Communication & Training Manager (Clinical Documentation/TMF) (m/f/d)

REFERENCE NUMBER:

505955/1

MY DUTIES:

- Responsible for the development and implementation of the communication and training campaign on Clinical Documentation Migration including Trial Master File within the organization under the leadership of the TMF Operational Excellence Head
- Develop Communication and Training Material for the transition from old system to the new: explain migration approach and scope, what to expect before-during-after the transition period, how to use tools, which processes to follow and what actions to take
- Drive Change Management, Communication and Training activities for Clinical Documents migration, and identify needs for different Line Units taking into consideration level of adoption and familiarity with the eTMF system
- Develop and execute communication strategy and plan, in collaboration with Change management team and line function representatives
- Identify training needs, define training objectives, develop and deliver training, measure training effectiveness and collect feedback and lessons learned. Collaborate with training teams in different line functions to deliver training as appropriate. Support, attend and present TMF trainings in multiple forums across different line functions.
- Serve as a liaison between process end-users and eDMS / TMF Governance and Management teams to drive user needs assessment workshops, technical solution discussions and implementation plan. Ensure best practice sharing and promote awareness. Pro-actively provide end-user solutions
- Promote best documentation practice to line functions to ensure that documents created/generated in the course of clinical research are managed and archived in accordance with GCP guidelines and SOPs

MY QUALIFICATIONS:

- Bachelor’s degree required; Advanced degree in life science preferred with profound experience in clinical operations and / or clinical document management
- Fluent English (oral and written)
- Experience in clinical operations
- Experience in communications/marketing preferable
- Work independently, leadership skills, change management, translating messages to end users,
- Experience in working with migrations of documents
- Thorough knowledge of clinical development process, regulatory requirements, Trial Master File and Good Clinical Practice
- Excellent understanding of system data structures and Clinical Document Management System functionality
- Ability to learn new systems readily
- Strong computer skills (EXCEL, MS Word) required
- Excellent attention to accuracy and details
- Excellent communication, organization and tracking skills
- Strong operational skills and demonstrated ability to meet timelines
- Proven networking skills and ability to train colleagues
- Strong interpersonal skills
- Ability to work under pressure
- Resolve issues with minimal supervision and understand when to escalate  

MY BENEFITS:

- Option for extension
- You will work in a global cross-functional multicultural and international team.

PROJECT INFORMATION:

- One of the biggest pharmaceutical company of the world

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Natascha Hanser

Reference number
505955/1

Contact
E-Mail: [email protected]