Senior Manager - TMF Management & Compliance

Salary & Benefits
Competitive
Employment Type
Full Time, Permanent
Department
TMF Management & Compliance
Report to Position
Director and Head of TMF Process Management and Quality Control
Location
EMEA Knowledge Centre, Hatfield, Hertfordshire
Business Area
Application Deadline
28 June 2019

Full Job Description

Your new role

As the Senior Manager for Eisai’s TMF Management & Compliance Team, you will be responsible for strategic & operational leadership of all TMF business processes & management of the eTMF system.

 

This will include:

  • Oversight and management of the end to end activities involved with the Quality Control review process to ensure study TMFs are of the highest quality and inspection ready, and meet compliance specifications according to regional regulations and ICH guidelines;

  • Managing the activities associated with the TMF business process, including continuous improvement activities and metrics;

  • Conduct oversight of the eTMF vendor and related TMF setup and maintenance processes, eTMF user support and training;

  • Engagement with Eisai functional and CRO stakeholders to deliver an inspection ready TMF

 

The role will also see you responsible for people management of the TMF Team for EMEA.

 

What are we looking for?

You will have demonstrated experience in a Regulatory, Clinical or related function gained within the Pharmaceutical or relevant Vendor environment.

 

This will include hands on experience with / knowledge of:

  • Clinical Document Management, TMF/eTMF, and/or Clinical Quality Control.

  • Domestic and international regulatory requirements (including ICH and GCP guidelines).

  • Key clinical trial documents (e.g., IBs, ICFs, CRFs, Protocols, regulatory approval documents).

  • The clinical development process.

 

You should also have previous people supervisory or line management experience.

 

What we offer in return

Eisai offers a competitive salary and excellent wider benefits package.

 

You will also be based from our excellent Knowledge Centre facility, which provides a great, collaborative working environment coupled with a campus feel including facilities such as restaurant, coffee shop and dry cleaning services.

 

What you need to do next

If you are interested in this position, please click the ‘click here to apply’ at the bottom or top of this advert. On submitting an application please include a copy of your CV for review. On applying, you will be asked for your current salary / package details, your notice period and your current location - applications without this information may not be considered.

 

If you have any questions, please contact us on recruitment@eisai.net.

 

We aim to respond to all successful applications as soon as possible. However please note unfortunately due to the volume of applications received we are unable to respond to unsuccessful applications.