whitefield bengaluru karnataka regulatory affairs Jobs – 48 Open Jobs Today

Senior Clinical Data Manager
Emmes Group —Bengaluru, Karnataka
- Full-time
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International Center for Nanodevices —Mathikere, Bengaluru, Karnataka
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Senior Clinical Data Manager

Emmes Group -
Bengaluru, Karnataka

Apply Now

Job details

Full-time
13 days ago

Qualifications

Computer science
Computer Science
SAS
Master's degree
SQL
Bachelor's degree
Data management
Organizational skills
Communication skills

Full job description

Overview:

Clinical Data Manager

Be Part of One Team, One Purpose.

At Emmes Group, we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.

Through our two business units—Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies.

We believe that every clinical breakthrough starts with people—people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.

The Senior Clinical Data Manager to oversee the collection, validation, and management of clinical trial data to ensure accuracy, integrity, and compliance with regulatory standards. The role involves leading data management activities, collaborating with cross functional teams, and ensuring the delivery of high quality data to support clinical study objectives.

Responsibilities:

Lead the design, development, and implementation of clinical data management plans (CDMPs) and
data handling procedures.
Manage and monitor the collection, cleaning, and validation of clinical trial data to ensure accuracy
and completeness.
Oversee the setup and maintenance of electronic data capture (EDC) systems and data standards
compliance (e.g., CDISC).
Collaborate closely with clinical operations, biostatistics, medical writing, and regulatory affairs teams
to support study timelines and deliverables.
Serve as the primary data management liaison for clinical trials, providing guidance and support to
study teams and external vendors.
Participate in study start up meetings, data review meetings, and audit preparation.
Ensure clinical data management activities comply with GCP, FDA, EMA, and other applicable
regulations.
Develop and implement data quality control procedures, discrepancy management, and data
reconciliation.
Support internal and external audits and inspections related to clinical data.
Mentor and train junior data management staff.

Qualifications:

Bachelor's Degree Life Sciences, Health Information Management, Computer Science, or related field. Required
Master's Degree Life Sciences, Health Information Management, Computer Science, or related field. Preferred
4-6 years - of experience in clinical data management (pharmaceutical, CRO, or biotech experience preferred). Required
1-3 years Prior experience with EDC systems and CDISC standards (SDTM/ADaM) preferred. Preferred
Proficiency in EDC systems as Medidata Rave, Veeva, InForm. High
Familiarity with data standards as CDISC, MedDRA, WHODrug. High
Experience with database lock processes, query management, and edit checks. High
Knowledge of SAS, SQL, or other data handling languages is a plus. High
Strong attention to detail and organizational skills. High
Excellent communication and interpersonal abilities. High
Ability to manage multiple projects and deadlines. High
team oriented mindset with proactive problem solving skills. High

CONNECT WITH US!
Find us on LinkedIn:/the-emmes-group/
Visit our website:https://www.theemmesgroup.com/

Apply Now

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