Job Skill: PDM - Protocol Data Management
Designation: Career Level - 10-Analyst
Job Location: Hyderabad
Qualifications: Any Graduation
Years of Experience: 5-8 years
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 the Data Maintenance team which is responsible for completeness & validity of the data in the clinical database. The team reviews and resolves discrepancies identified by the system or through manual checks as per guidelines, issue data clarification forms as and when required. You will have to perform discrepancy review & perform Self-Evident Corrections per DRP (as and when required). You will also solve for 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 increasingly complex problems. Interaction is with peers within Accenture before updating supervisors. Likely has some interaction with clients and/or Accenture management. Minimal instruction on daily work tasks and a moderate level of instruction on new assignments will be provided. Decisions made by you impact your own work and may impact the work of others. In this role the person would be an Individual contributor and/or oversees a small work effort and/or team. Please note that this role may require you to work in rotational shifts.