Job Description

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

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)

Skills Required