Karnataka Regulatory affairs Jobs – 52 Open Jobs Today

Sr Clinical Database Programmer
Veranex, Inc. —Bengaluru, Karnataka
- Computer Science
- Databases
- Bachelor's degree
Quick apply
5d
Business Development Associate
Clini launch Research Institute —Bengaluru, Karnataka
- Up to ₹18,000 a month
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
12d
Senior Clinical Data Manager
Emmes Group —Bengaluru, Karnataka
- Full-time
- Computer science
- Computer Science
- Master's degree
CTM II (Oncology, Immunology) (Mumbai office based)
Syneos - Clinical and Corporate - Prod —Indi, Karnataka
- Full-time
- Project management
- Bachelor's degree
- Travel
1d
Business Development Manager (Global Payments)
Revolut —Bengaluru, Karnataka
- Full-time
- Financial services
- Communication skills

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Business Development Associate
Clini launch Research Institute —Bengaluru, Karnataka
Exposure to the clinical research and healthcare education industry. Pay: Up to ₹18,000.00 per month. The ideal candidate will be responsible for generating…
Up to ₹18,000 a month
Quick apply
12d
Business Development Associate (BDA)
Clini launch Research Institute —Bengaluru, Karnataka
Clinilaunch Research Institute is a leading healthcare and clinical research training institute offering industry-focused programs in Clinical Research, Medical…
₹18,000 - ₹20,000 a month
Quick apply
12d

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Sr Clinical Database Programmer

Veranex, Inc. -
Bengaluru, Karnataka

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Job details

5 days ago

Qualifications

Clinical research
Computer Science
Databases
Bachelor's degree
Product development
Research & development
Medical terminology
Communication skills

Full job description

Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.

About This Role:
Veranex has an exciting opportunity to join our team as a Sr Clinical Database Programmer. You will be part of a team working to improve lives globally through medical technology innovation. The Sr Clinical Database Programmer will be responsible for performing all study initiation set-up activities and attends kick-off meetings. Programs, performs unit testing, and maintains databases. Generates, maintains, and archives all study related documents. Participates in the setup and testing of the risk-based monitoring model and the Randomization and Trial Supply Management (RTSM) configuration testing. Assists with internal audits and attends sponsor audits. Trains and mentors new or junior programmers. Performs batch upload / data upload tasks in support of IRT integration. Provides advanced technical expertise and support to clinical database programming and data management teams.

What You Will Do:

Demonstrate strong expertise in complex custom function programming, including advanced edit checks, derivations, and system validations to support complex protocols and study designs.
Demonstrate strong expertise in protocol interpretation, translating complex protocol requirements into robust EDC designs, CRFs, edit checks, and database specifications.
Lead end-to-end clinical database design, development, and delivery for complex studies, acting as Study Lead and single point of contact for sponsors and cross-functional teams.
Provide hands-on experience in TSDV, RTSM setup, testing, integrations, and issue resolution; experience in RTSM is a strong added advantage.
Strong expertise in managing post production change requests, such as mid study updates, protocol amendments, impact assessment, revalidation, and controlled deployments and migration while ensuring data integrity.
Mentor junior programmers, manage timelines and deliverables, proactively identify risks, and ensure high-quality outputs aligned with SOPs, client expectations, and regulatory standards.
7-9 years of relevant work experience in custom functions

Qualifications:Required skills:

Bachelor’s degree or international equivalent in computer science or related field.
7 - 9 years of relevant work experience
A seasoned professional with full understanding of area of specialization. Resolves a wide range of issues in creative ways. Fully qualified level of the role.
Works on problems of diverse scopes where analysis of data requires evaluation of identifiable factors.
Exercises judgment in selecting methods and techniques for obtaining solutions.
Networks with senior internal and external personnel in area of expertise.
Works independently; receives minimal guidance on day-today work and new projects or assignments.

Preferred:

In-depth knowledge of clinical research and the drug development process
Strong knowledge of medical terminology, Good Clinical Practices (ICH GCP), CDASH, and DISC
In-depth knowledge of databases, validation, programming, word-processing and spreadsheet software
Strong knowledge of programming languages
Strong programming skills
Strong written and Oral communication skills
Excellent attention to detail
Ability to solve moderate to complex problems
Strong ability to effectively manage multiple tasks and projects

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.

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regulatory affairs jobs in karnataka

Sr Clinical Database Programmer

Business Development Associate

Senior Clinical Data Manager

CTM II (Oncology, Immunology) (Mumbai office based)

Business Development Manager (Global Payments)

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