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Clinical Data Svs Specialist
Bengaluru
Job No. aioc-s01528978
Full-time
Job Description
Skill required: Clinical Data Services - Clinical eTMF Management
Designation: Clinical Data Svs Specialist
Qualifications:Bachelor of Pharmacy/Master of Pharmacy
Years of Experience:7 to 11 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. You will be expected to use 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? •Clinical eTMF Management •Adaptable and flexible •Ability to perform under pressure •Problem-solving skills •Detail orientation •Ability to establish strong client relationship
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
Designation: Clinical Data Svs Specialist
Qualifications:Bachelor of Pharmacy/Master of Pharmacy
Years of Experience:7 to 11 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. You will be expected to use 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? •Clinical eTMF Management •Adaptable and flexible •Ability to perform under pressure •Problem-solving skills •Detail orientation •Ability to establish strong client relationship
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
Qualifications
Bachelor of Pharmacy,Master of Pharmacy
Please be informed that at any given point in time, you can only have one "Active" application.
Please be informed that at any given point in time, you can only have one "Active" application.