Job Skill: PDM - Protocol Data Management
Designation: Career Level - 09-Consultant
Job Location: Bengaluru
Qualifications: Any Graduation
Years of Experience: 7-8 years
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You will be aligned with our Pharmaceuticals Processes vertical and help us with the processes to collect, monitor, research, assess and evaluate information on the adverse effects of medication with a view to identifying new information about hazards associated with medicines and consequently, prevent harm to patients. It also deals with the reviewing and resolving of discrepancies identified by the system or through manual checks as per guidelines. Employees under this span can also be responsible for a number of activities related to the design, development, and maintenance of Clinical Database objects.
You will be working as a part of CDM - Clinical Data Management team which is responsible for the completeness and validity of the data in the clinical database. They review and resolve discrepancies identified by the system or through manual checks as per guidelines. Issue data clarification forms as and when required. Perform discrepancy review and perform Self-Evident Corrections per DRP (as and when required). Perform discrepancy management for SAE related discrepancies.
You will be responsible for PDM - Protocol Data Management where in you will support data management tasks for maintenance through database lock and submission. Sr. PDMs are segregated into teams supporting either study startup or review to lock tasks/processes to ensure efficiency and quality throughout the life of the clinical trial. You will be responsible for data management review to lock activities of assigned protocols and independently oversee database update process. You will be responsible for proactively identifying and resolving issues noted during data management which impacts the overall timeline and informs the appropriate Client team members (e.g. Clinical Site Managers, Protocol Manager, Site Monitor, Medical Encoders, eClinical Support & Submissions, Data Leads, Global Pharmacovigilance). You will also have to coordinate follow-up.
Good to have skills: Good communication 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.
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