Clinical Data Svs Sr Analyst

Accenture; Bengaluru; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

A global professional services firm in India is seeking a Clinical Data Svs Sr Analyst to manage clinical data with a focus on quality and compliance. Candidates should possess an MSc and have 5-8 years of experience in clinical data services, including expertise in CDISC, SDTM, and ADaM. Strong problem-solving skills and attention to detail are essential. The role involves working in a fast-paced environment and collaborating with various teams.

Qualifications

• Candidates must have an MSc and a bachelor's degree in Life Sciences or relevant field.
• Clinical Data harmonization expertise in CDISC, SDTM, and ADaM is preferred.
• Knowledge of ICH, GCP, and regulatory guidance is essential.

Responsibilities

• Perform data management activities including discrepancy review and query generation.
• Manage clinical data management projects following FDA submission standards.
• Collaborate cross-functionally in a fast-paced environment.

Skills

Adaptability

Problem-solving skills

Detail orientation

Client relationship establishment

Verbal and written communication

Education

MSc

Bachelor's degree in Life Sciences

Bachelor’s degree in Computer Science or IT

PG diploma in Clinical Research & Trial Management

Tools

Microsoft Office (Excel, Word, PowerPoint)

Job description

About The Role

Skill required: Clinical Data Services - SDTM Mapping

Designation: Clinical Data Svs Sr Analyst

Qualifications: MSc

Years of Experience: 5 to 8 years

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.

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 manages clinical data management projects. A standard structure for human clinical trial data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).

What are we looking for?

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

Roles and Responsibilities

• All project team members at minimum will have bachelor's degree in Life Sciences or equivalent.
• For programming requirements, a bachelor’s degree in computer science, Information Technology or relevant field will be required.
• Clinical Data harmonization expertise in Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Modules (SDTM) and Analysis Data Model (ADaM); evaluation and manipulation of pooled clinical datasets would be preferred.
• PG diploma in Clinical Research & Trial Management would be an added advantage.
• Therapeutic Area knowledge of Cardiovascular, Neuroscience, Oncology solid tumors preferred.
• Good verbal and written communication skills desired. Must be able to develop strong interpersonal skills within the team.
• Must have skills for Microsoft office tools like Excel, Word, and PowerPoint.
• Knowledge of ICH, GCP, and other regulatory guidance as applicable to management of clinical documentation.
• Ability to work in an extremely fast‑paced environment with changing priorities.
• Ability to work collaboratively and cross‑functionally.
• Attention to detail and accuracy in work.

Qualification

MSc