Skill required: Clinical Data Operations - Clinical Data Review
Designation: Clinical Data Svs Specialist
Qualifications:BSc/MSc/Bachelor of Pharmacy
Years of Experience:7 to 11 years
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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 worldâ€™s leading biopharma companies bring their vision to life â€“ 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.
You will be expected to manage & review data generated through manual or programmed listings including, but not limited to all external data sources and SAEs.
What are we looking for? •Commitment to quality
•Ability to perform under pressure
•Collaboration and interpersonal skills
Roles and Responsibilities: •In this role you are required to do analysis and solving of moderately complex problems
• May create new solutions, leveraging and, where needed, adapting existing methods and procedures
• The person would require understanding of the strategic direction set by senior management as it relates to team goals
• Primary upward interaction is with direct supervisor
• May interact with peers and/or management levels at a client and/or within Accenture
• Guidance would be provided when determining methods and procedures on new assignments
• Decisions made by you will often impact the team in which they reside
• Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture
• Please note that this role may require you to work in rotational shifts