Clinical System Leader

3 days ago

Hyderabad Secunderabad Telangana, India beBeeSystem Full time ₹ 1,04,000 - ₹ 1,30,878

We are seeking a skilled professional to join our team as a Clinical Systems and Analytical Reporting (CSAR) Team Lead. This role is a crucial blend of technical expertise and leadership, where you'll build and program studies in our clinical trial database while ensuring compliance with regulatory standards.

Roles & Responsibilities
  • Study Design & Programming: You will design, develop, and implement studies in the clinical trial database, adhering to best practices and regulatory guidelines. A key part of this is the development of custom functions and edit checks.
  • Technical Leadership: Serve as a technical point of contact for system deliverables on defined programs. You will provide technical and business process expertise on new and emerging technologies and act as a data scientist to support decision-making through analytical insights.
  • Process & Quality Assurance: Ensure the efficient and consistent use of EDC systems in compliance with established procedures. You will also develop, review, and implement policies, SOPs, and other documentation to ensure all CSAR activities are consistent with regulatory and established processes.
  • Collaboration: Partner effectively with other CSAR Operations and cross-functional staff to ensure seamless deliverables. You'll also assist in preparing for and responding to audit findings.
  • Innovation: Identify, recommend, or implement system enhancements, new tools, or emerging technologies to decrease database development cycle times and foster a collaborative environment.
Required Skills & Qualifications
  • A Bachelor's degree or equivalent in life science, computer science, business administration, or a related discipline.
  • An advanced degree is preferred.
  • General biopharmaceutical clinical research experience.
  • Experience in oversight of outside vendors (CROs, central labs, etc.) is a plus.
Benefits

This role offers a unique opportunity to work with cutting-edge technologies and make a significant impact on the pharmaceutical industry. If you're a motivated and results-driven individual with a passion for innovation, we encourage you to apply.

Others

Please note that this job description is not exhaustive and may be subject to change based on the company's needs. We are an equal opportunities employer and welcome applications from diverse candidates.

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