Clinical Data Management Associate

Orcapod Consulting Services

Hyderabad, Chennai District, Bengaluru

Hybrid

INR 1,200,000 - 1,800,000

Full time

6 days ago
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Job summary

Orcapod Consulting Services is seeking an Associate Clinical Data Management professional in Hyderabad with 7–10 years of CDA experience. The role involves managing end-to-end data management activities across clinical studies, including setup, data review, queries, and database locks, while leveraging Medidata Rave or Oracle InForm.

You will coordinate with Clinical Operations, Statistics, SAS, and other teams to ensure timelines, quality, and compliance with GCP and SOPs, while guiding the CDM

Qualifications

  • 7–10 years of clinical data management experience in studies.
  • Experience with EDC/CDMS systems and data cleaning.
  • Strong knowledge of GCP and SOPs.

Responsibilities

  • Manage end-to-end CDA activities for clinical studies.
  • Handle study setup, data review, query management, and database lock.
  • Work with EDC/CDMS systems such as Medidata Rave or Oracle InForm.
  • Coordinate with Clinical Operations, Statistics, SAS and cross-functional teams.
  • Lead CDM team members and assist issue resolution.
  • Participate in UAT, edit check review, and database validation.

Skills

Clinical Data Management
EDC/CDMS
Data Review & Query Management
Database Lock
UAT/Edit Checks
GCP
Clinical Trials
Client/Sponsor Management

Education

Bachelor's/Master's in Life Sciences, Pharmacy, Clinical Research, Biotechnology

Tools

Medidata Rave
Oracle InForm

Job description

Position: Associate Clinical Data Management

Experience: 7-10 Years
Location: India
Work Mode: Hybrid / Remote

Immediate joiners/15 days

Job Description
  • Manage end-to-end Clinical Data Management activities for clinical studies.
  • Handle study setup, data review, query management, data cleaning and database lock.
  • Work on EDC/CDMS systems such as Medidata Rave, Oracle InForm or similar tools.
  • Perform data reconciliation with safety, laboratory and other external data.
  • Coordinate with Clinical Operations, Statistics, SAS and other cross-functional teams.
  • Communicate with clients/sponsors and provide study updates.
  • Support study timelines, quality and compliance with GCP and SOPs.
  • Lead/guide Clinical Data Management team members and support issue resolution.
  • Participate in UAT, edit check review and database validation activities.
Required Skills
  • Clinical Data Management
  • EDC / CDMS
  • Medidata Rave / Oracle InForm
  • Data Review & Query Management
  • Database Lock
  • UAT / Edit Checks
  • GCP
  • Clinical Trials
  • Client/Sponsor Management
Qualification

Bachelors/Masters degree in Life Sciences, Pharmacy, Clinical Research, Biotechnology or related field.

Preferred

Experience in CRO/Pharma and end-to-end clinical study management.

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