Senior Database Designer (Clinincal Database)

Job Designation : Senior Data Base Designer

Location : Hyderabad

Tenure : 3 months to 6 months

Main responsibilities:

1. Designing study database/eCRF per protocol and implementing dynamism and edit check programming/Custom function Programming per data collection and cleaning needs in

Medidata Rave

2. Ensuring clinical database post-production maintenance including impact assessment analysis and database migration

3. Developing, reviewing and updating the study setup Gantt Chart to comply with study timeline, and following-up the data management related tasks accordingly

4. Configuring Sanofi specific solutions interfaced with the clinical data management systems (e.g., Safety to RAVE interface)

5. Requesting new database models or updates to the Clinical Information Governance team

6. Managing the technical writing at study team level (i.e., user guides, detailed specifications, best practices, programming conventions, etc.)

7. Analysing new requirements from customer and propose technical solution strategies

About you:

Experience:

• At least 5 years experience in clinical database design and maintenance are required and he/she can lead database design and maintenance for complex trials independently.
• In addition, clinical trial experience, clinical data management experience and pharmaceutical industry experience are preferred.

Soft and technical skills:

• Advanced project management skill
• Advanced collaboration and communication skill
• Outstanding capability of independent thinking and delivery of accurate outcomes
• Meeting management skill such as organize meeting and discussion
• Crystal clear logical thinking
• Advanced expertise in Clinical Data Management Systems (e.g. Medidata Rave, etc.)
• Advanced expertise in database setup and conduct in Medidata Rave.
• Advanced expertise in Custom function Programming (C#).
• Knowledge of industry standards and practices (e.g. CDISC especially CDASH and
• SDTM)
• Strong knowledge of current regulatory guidelines, and GCP practices regarding
• Data Management
• Understanding of advanced drug development concepts such as Decentralized
• Clinical Trials (DCT), Master & Adaptive Protocols, eSource and AI Based
• automations is a plus

Education:

Bachelor or Master of Science degree or above, preferably in a life science or

mathematics-related area (e.g., Pharmaceutical, medical, or mathematics,

computer science or similar technical fields).

Languages:

Strong English skills (verbal and written), ability to exchange fluently in a global

environment.

Interested candidates can reach us

Email : [email protected]

Whatsapp : 9394368397

Thanks & Regards,

Manpower Group