Clinical Data Svs Associate

Accenture; Hyderabad City Taluka; On-site; PKR 8,469,000 - 11,294,000; Full time

Job summary

A leading global professional services company is seeking a Clinical Data Svs Associate in Hyderabad. This role requires a Bachelor of Pharmacy and 1 to 3 years of experience. Responsibilities include performing document checks for eCTD compliance and managing data quality in clinical trials. Ideal candidates should be adaptable, detail-oriented, and skilled in client relations. This position offers a chance to impact life sciences projects globally.

Qualifications

• 1 to 3 years of relevant experience is required.
• Must possess strong problem-solving skills.
• Detail orientation and adaptability in various situations are essential.

Responsibilities

• Perform format checks of documents for eCTD compliance.
• Ensure submission documents meet format standards.
• Conduct data management activities including discrepancy review.

Skills

Adaptable and flexible

Ability to perform under pressure

Problem-solving skills

Detail orientation

Ability to establish strong client relationship

Education

Bachelor of Pharmacy

Job description

Skill required:

Clinical Data Services - Clinical eTMF Management

Designation:

Clinical Data Svs Associate

Qualifications:

Bachelor of Pharmacy

Years of Experience:

1 to 3 years

About Accenture

Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities. Visit us at www.accenture.com

What would you do?

You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.

The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.

Strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. Includes data review and accuracy checks of trial master file table of contents, head quarters, initial full protocol package and amended FPP checklists, end of trial checklists, essential document reconciliation, and clinical study report appendices.

What are we looking for?

• Adaptable and flexible
• Ability to perform under pressure
• Problem‑solving skills
• Detail orientation
• Ability to establish strong client relationship

Roles and responsibilities:

Document Administrators are responsible for carrying out format check of documents requiring eCTD compliance for New Drug Application/Marketing Authorization Submission. The format check ensures that the technical quality of submission documents in eCTD compliant and meets the document format standards (e.g., PDF property checks, good documentation practice and bookmark/hyperlink checks).