Project Clinical Data Programmer

1 month ago

Bengaluru, India Novo Nordisk Full time

**Department**:Data Systems & Automation, Clinical & Data Science (CDS) GBS

**About the department**

Data Systems & Automation, Bangalore Global Development is one of the most competent and diverse team of professionals who are mainly responsible for providing functional and system support to execute clinical trials across Product Development Plan portfolio. The team has strong understanding of Clinical Systems & interfaces with end-to-start mindset on standardisation of data-flow across systems, Electronic Case Report Form (eCRF) development using Central Designer and hands-on experience with Clinical Data Interchange Standards Consortium (CDISC) concepts annotated Case Report Form (aCRF), Study Data Tabulation Model (SDTM) mapping, SAS programming, Study Data Review Guideline (SDRG) etc., to aid CDISC submission which is a mandate from regulatory authorities.

**The position**

As a Project Clinical Data Programmer, Provide inputs to Protocol outline & protocol on data collection. Responsible for implementation and adherence to Project standards template in EDC and DMW. Ensure design and set-up of study database for clinical trials are aligned across trials within project, including new therapeutic areas. Additionally responsible for performing various tasks related to Automization, Robotics, AI, Machine Learning. Provide expert process inputs and perform on the job mentoring.
- Responsible for implementation and maintenance of standard template in EDC and DMW. Align with the PDMs to understand the project requirements (CRF and external data) for new programs/projects.
- Responsible for tracking and implementation of the new requests for DMW template creation. Enforce consistent use of Global Standards across therapeutic areas and project standards within project areas.
- Ensure design and set-up of study database for clinical trials are aligned across trials within project, including new therapeutic areas. Responsible for alignment across trials/programs within project to ensure standardized database trial build and interface mappings in collaboration with Trial Data Management colleagues and other stakeholders.
- Ensure that the newest knowledge is collected and shared with relevant stakeholders including super users in Clinical & Data Science on trial build, SDTM standards, interface integrations including EDC, DMW, IWRS, ePRO etc.
- Ensure design and set-up of study database for clinical trials are aligned across trials within project, including new therapeutic areas. Responsible for alignment across trials/programs within project to ensure standardized database trial build and interface mappings in collaboration with Trial Data Management colleagues and other stakeholders.

**Qualification**:
You are expected to have the below skills and knowledge:

- M.Sc / B.Sc in Life Science or comparable degree in computer science, Information Technology clinical information management or equivalent qualifications.
- Minimum 8-10 years of experience in pharmaceutical industry and preferably 7 years within clinical data management and hands on experience in CDISC SDTM.
- Expert knowledge on end to end clinical data management activities.
- Expert knowledge of computer systems involved in clinical data management and mandatory experience in programming languages (eg: SAS/SQL/R Jupyter etc).
- Expert knowledge on AI & ML
- Sound knowledge with analysis and design of business processes and functional design within the area of drug development.
- Extensive experience with collaboration across professional and regional borders.
- Participation in conferences/workshops.
- Demonstrated experience with project management and stakeholder management.
- Profound knowledge of GxP and guidelines within drug development.
- Advanced knowledge of relational database systems and data models.
- Knowledge about regulatory activities.
- Clear communication and facilitation of agreement between multiple stakeholders to ensure smooth end-to-end processes
- Quality mind-set and strong analytical skills.
- M.Sc. / B.Sc. in Life Science or comparable degree in computer science, Information Technology clinical information management or equivalent qualifications.
- Minimum 7-8 years of experience in pharmaceutical industry or handling projects across different domains.
- Project Management experience like AGILE, SaFE, SCRUM methodologies.
- Motivated self-starter and team player, works well with others and interacts effectively and efficiently with internal or external people and groups
- Extensive cross functional team expertise including technical and non-technical work
- Must have ability to prioritize, multi-task and meet deadlines and work without supervision and escalate where necessary.
- Organized and detail oriented with excellent written and verbal communication skills.
- Ability to work in a diverse multi-cultural environment.
- Team oriented personality with a high degree of flexibility.
- Planning / Co-ordinating abilities,

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