Clinical Data Manager

Avance Clinical Pty Ltd.; Bengaluru South; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Avance Clinical Pty Ltd. is seeking an experienced Data Manager to join our contract research organization in Bengaluru South, Karnataka, India.

You will manage the data life cycle for clinical trials, ensuring accuracy, consistency and regulatory compliance in a GCP environment. Responsibilities include creating data management plans, reviewing edit checks, developing CRFs, validating databases, and training site staff on eCRF systems.

Qualifications

• Ordinary degree in the appropriate discipline or equivalent experience.
• 4–5 years of experience in the pharmaceutical industry / CRO in a GCP environment.
• Knowledge of ICH GCP guidelines, medical terminology, and the clinical trials process.
• Experience in EDC/e-CRF systems.
• Intermediate MS Office Suite.

Responsibilities

• Preparation of Data Management Plans.
• Preparation or review of Edit Check Document.
• Development and review of Case Report Forms (CRFs) and completion guidelines in line with the database and protocol.
• Preparation of clean and erroneous dummy data.
• Database Validation (testing data entry screens and edit checks using dummy data).
• Provide training to site, Sponsor and other staff in the use of eCRF systems.
• Resolution of Quality Assurance (QA) comments.
• Perform data review and cleaning of data collected during the trial.
• Perform Quality Control on study data prior to lock.
• Act as Data Project Manager including interaction with Clinical Project Manager, interact with site/ client/ external vendors, perform overall Project Management and timeline management.

Skills

GCP knowledge

EDC/eCRF experience

MS Office proficiency

Clinical trials process understanding

Pharma/CRO experience

Education

Bachelor degree in life sciences or related

Job description

Who are we?

We're Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980s. If you already work in this industry you'll know that we are experts in our field.

Why should you join Avance Clinical?

We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.

• We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

Responsibilities

• Preparation of Data Management Plans.
• Preparation or review of Edit Check Document.
• Development and review of Case Report Forms (CRFs) and completion guidelines in line with the database and protocol.
• Preparation of clean and erroneous dummy data.
• Database Validation (testing data entry screens and edit checks using dummy data).
• Provide training to site, Sponsor and other staff in the use of eCRF systems.
• Resolution of Quality Assurance (QA) comments.
• Perform data review and cleaning of data collected during the trial.
• Perform Quality Control on study data prior to lock.
• Act as Data Project Manager including interaction with Clinical Project Manager, interact with site/ client/ external vendors, perform overall Project Management and timeline management.

What You'll Need To Succeed

• Ordinary degree in the appropriate discipline or equivalent experience.
• 4-5 years experience in the pharmaceutical industry / CRO working in a GCP environment.
• Knowledge of ICH GCP Guidelines, medical terminology and clinical trials process.
• Experience in EDC/e-CRF systems.
• Intermediate MS Office Suite.