About the role
Responsibilities:
- You will be aligned with our Life Sciences R& D vertical. Our services span the entire life sciences enterprise, from research laboratories, clinical trial 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, and Regulatory, helping the world's leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.
- Clinical Data Operations involves the management and oversight of data collected during clinical trials. This includes data collection, validation, storage, and analysis to ensure accuracy and compliance with regulatory standards. The goal is to support clinical research by providing high-quality data that can be used to evaluate the safety and efficacy of medical treatments.
- A critical phase in clinical research that assures collection, integration, and availability of data at appropriate quality and cost. It also supports the conduct, management, and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH).
- The Clinical Data Manager is responsible for end-to-end data management activities across clinical trials, ensuring high-quality, reliable, and regulatory-compliant clinical data to support study objectives and regulatory submissions.
- Study Setup and Start-up, Study Conduct, and Study Close-out with Stakeholder Management and Compliance and Quality.
- In this role, you are required to do analysis and solve increasingly complex problems.
- Your day-to-day interactions are with peers within Accenture.
- You are likely to have some interaction with clients and/or Accenture management.
- You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments.
- Decisions that are made by you impact your own work and may impact the work of others.
- In this role, you would be an individual contributor and/or oversee a small work effort and/or team.
- Please note that this role may require you to work in rotational shifts.
Requirements:
- Bachelor's Degree in Life Sciences/Master's Degree in Life Sciences.
- Years of Experience: 5 to 8 years.
- Ability to establish strong client relationships.
- Ability to manage multiple stakeholders.
- Ability to meet deadlines.
- Ability to perform under pressure.
- Ability to work well in a team.
- Hands-on experience with EDC systems (Medidata Rave, Inform, Veeva, etc. ).
- Exposure to data visualization/reporting tools and Excel.
- Knowledge of coding dictionaries (MedDRA, WHO-DD).
- Bachelor's Degree in Life Sciences; Master's Degree in Life Sciences.