Job Description

Primary Job Function

The Clinical Services Operational Specialist supports the efficient and compliant execution of Global Program Management activities to internal and external standards by supporting the Clinical Services Team in various projects.

Core Job Responsibilities

CTMS


Preparation of Training Material for CTMS


Providing user support as CTMS subject matter expert


Support CTMS team in all activities required for system upgrades or for release of new CTMS modules


Handle general CTMS requests


Data integrity and validation checks checks to ensure information is complete for reporting


Trial Disclosure


Subject matter expert for Trial Disclosure


Responsible for disclosure of studies in the various disclosure registers as required


eTMF


Subject matter expert for document management system


Ensure system is aligned with the SOP


Update TMF according to DIA eTMF release notes


Training


Support implementation and maintenance of documentation and training systems within medical office


Acts as super user for selected systems


Maintain CTMS matrix


CTMS Training maintenance and generation of new training courses a s needed


Liaising with Learning Management System coordinator for training assignment


SOP


Contribute to reviewing and updating SOP and processes as required


Dashboard


Support in creating dashboards in PowerBI/ other BI applications

Position Accountability / Scope:

Responsible for CTMS Training Material Development Responsible for supporting dashboard creation as per the needs Responsible for eTMF, Trial Disclosure Responsible for quality control Internal stakeholders Medical Office (Medical Affairs, Clinical Development and Pharmacovigilance), Quality Assurance, Regulatory Affairs, Office of Ethics and Compliance, global, regional and local
External stakeholders business partners (contractors, consultants, vendors)

Minimum Education

Masters in Science / Computers /Advance Data Analytics degree or equivalent by experience

Experience:

At least 5-years' experience in pharmaceutical industry/ IT software industry/ Data Analytics Experience with working in a Global fast paced environment Attention to detail, organized, capable of multi-tasking, capable of working independently Proficient in MS office applications especially Excel and Word Experience of records management/ quality control/ system management preferable * Fluent in English