Clinical Services Operational Specialist

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

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Clinical Affairs / Statistics

DIVISION:

EPD Established Pharma

LOCATION:

India Mumbai : Mumbai Development Center - EPD

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)