Clinical Document Specialist

The Clinical Document Specialist (CDS) will provide support for Trial Master File (TMF) activities to the clinical teams for assigned projects.

This role will be responsible for the overall management and quality maintenance of essential clinical trial and other designated documents, including the set up and maintenance of the Trial Master File (TMF).

The CDS will have a strong focus on ensuring routine document management operations are performed with adherence to Novotech SOPs.

This role to manage Trial Master Files (TMF), both electronic and paper in format according to project requirements, ICH GCP guidelines, local/global regulatory requirements, and Novotech/Client SOPs.

Minimum Qualifications & Experience:
Minimum bachelor s degree with concentration in Life Sciences.


At least 5 years of experience in a clinical research organization or equivalent role.


Practical experience in handling Trial Master File activities including paper or electronic-TMF (eTMF).


Prior background in the pharmaceutical, CRO or healthcare industry is advantageous.


Have good knowledge of eTMF systems.



Responsibilities:
CDS will perform the responsibilities of a subject matter expert to the highest competency and act as both a document uploader and QC reviewer.

CDS is responsible to liaise directly with the client/alliance partner counterpart (if assigned) with respect to assigned responsibilities.


CDS will contribute to maintenance and delivery of team Training Programs and serve as a trainer/mentor to new team members.

Identify, develop, and lead potential TMF process improvements which can improve centralized workflows and drive efficiencies across Novotech.


CDS maintains an understanding of applicable regulatory requirements and changes with TMF Management requirements and keeps Novotech tools and processes updated accordingly.


CDS may lead the development of the assigned project Filing Plan with Team Lead/Project Manager and is involved in assessing overall customer satisfaction for all studies with the central filing function, working with internal and external customers to resolve issues and ensure all SOP requirements are delivered.