Interactive Response Technologies Project Manager

4 weeks ago

Hyderabad, Telangana, India Statistics & Data Corporation (SDC) Full time
Job Summary

We are seeking an experienced Project Manager to oversee and coordinate all IRT activities in support of clinical and/or non-clinical research studies. The successful candidate will manage the day-to-day IRT project activities, including timelines, budgets, staff, project scope, reports, and communication for the lifecycle of the project(s).

Key Responsibilities
  • Lead IRT study setup activities, including IRT design and specification documents, and approval and user acceptance testing.
  • Allocate and prioritize workloads for multiple projects.
  • Serve as primary client contact for IRT.
  • Work with Clinical Data Managers and Statistical Leads to manage timelines and budgets as they pertain to IRT activities.
  • Work with the study team to reconcile IRT data with clinical data and oversee data transfers.
  • Mentor IRT Programmer on IRT build requirements.
  • Develop documentation for validation and maintenance of IRT databases for clinical trials using a variety of validated software applications.
  • Maintain quality control of the data, project deliverables, and closeouts.
  • Adhere to all aspects of SDC's quality system.
  • Comply with SDC's data integrity and business ethics requirements.
  • Develop and maintain SOPs and tools relating to the IRT.
  • Perform other related duties incidental to the work described herein.
Requirements
  • Exceptional working knowledge of clinical trials and IRT role in the clinical trials process.
  • A minimum of 1 year of staff mentoring and leadership experience.
  • Strong leadership capabilities.
  • Strong delegation abilities.
  • Highly effective communication skills, both written and verbal.
  • Ability to work as a member of a multi-disciplinary team and adapt to changing priorities.
  • Training and experience in clinical database management.
  • General knowledge of GCPs and the conduct of clinical trials.
  • Understanding of the clinical research process flow and drug development processes.
  • Understanding of software development and testing processes.
  • Demonstrated proficiency in office productivity applications (e.g., Microsoft Word, PowerPoint, and Excel).
  • Excellent organizational skills.
  • Ability to manage multiple tasks simultaneously and to prioritize tasks effectively.
  • Demonstrated ability to focus on project work and efficiently bring projects to completion.
  • Ability to effectively manage projects, budgets, and timelines.
  • Ability to learn new systems without formal training.
Education or Equivalent Experience

Bachelor's degree in engineering, applied or life science, and at least two (2) years of experience in management of an IRT system, or Associate's degree in engineering, applied or life science, and a minimum of five (5) years of experience in management of an IRT system.

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