Senior Clinical Data Manager

Emmess Services; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Emmess Services in Bengaluru, India seeks an experienced Clinical Data Manager to lead CDMP design, data quality, and EDC system oversight for clinical trials.

You will collaborate across clinical operations, biostatistics, medical writing, and regulatory affairs to ensure timelines and deliverables, while mentoring junior staff and supporting audits.

Qualifications

• Bachelors or higher in Life Sciences, Health Information Management, Computer Science, or related field.
• Masters preferred in Life Sciences, Health Information Management, Computer Science, or related field.
• 4-6 years of experience in clinical data management (pharma/CRO/biotech preferred).
• 1-3 years of experience with EDC systems and CDISC standards (SDTM/ADaM) preferred.
• Proficiency with EDC systems such as Medidata Rave, Veeva, InForm.

Responsibilities

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

Skills

SAS/SQL knowledge

Attention to detail

Communication skills

Multi-project management

Education

Bachelor's Degree in Life Sciences / Health Information Management / Computer Science or related field

Master's Degree in Life Sciences / Health Information Management / Computer Science or related field

Tools

Medidata Rave

Veeva

InForm

Job description

Job Summary

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.

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

• Bachelors Degree Life Sciences, Health Information Management, Computer Science, or related field.
• Masters Degree Life Sciences, Health Information Management, Computer Science, or related field.
• Required 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.

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