APM/PM - Late Phase - Brillex Clinical Research

2 days ago

Ahmedabad Gandhinagar, India Brillex Clinical Research Pvt. Ltd. Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Role & responsibilities

  • Develop and manage comprehensive project plans, including timelines, budgets, resource allocation, and risk mitigation strategies.
  • Oversee all aspects of trial startup, including site selection, contract negotiation, IEC/IRB submissions, and study team training.
  • Monitor trial progress against established milestones and timelines, proactively identifying and addressing potential delays or roadblocks.
  • Manage project budgets, track expenses, and ensure cost-effectiveness.
  • Collaborate with cross-functional teams (e.g., medical, biostatistics, data management, regulatory) to ensure seamless project execution.
  • Manage vendor relationships, including selection, contract negotiation, and performance monitoring.
  • Serve as the primary point of contact for study sites, sponsors, and other stakeholders.
  • Facilitate effective communication among study team members, ensuring timely dissemination of information and updates.
  • Prepare and present regular project status reports to management and stakeholders.
  • Foster a collaborative and productive working environment within the study team.
  • Ensure adherence to all applicable regulations, guidelines (e.g., GCP, FDA), and company SOPs.
  • Monitor data quality and integrity, identifying and resolving any discrepancies or issues.
  • Implement quality control measures and participate in audits and inspections.
  • Maintain accurate and up-to-date study documentation.
  • Identify and assess potential risks to trial success, including patient safety, data integrity, timelines, and budget.
  • Develop and implement risk mitigation strategies to minimize the impact of potential risks.
  • Proactively monitor and manage risks throughout the trial lifecycle.
  • Provide leadership and guidance to study team members, fostering a positive and productive work environment.
  • Delegate tasks effectively, ensuring appropriate distribution of responsibilities.
  • Mentor and develop junior team members, promoting professional growth and development.
  • Perform other duties as assigned by HOD.

Preferred candidate profile

  • Bachelor's degree in a scientific or related field; Master degree preferred.
  • Thorough understanding of GCP, FDA regulations, and other relevant guidelines.
  • Proven ability to manage complex clinical trials, including budget management and vendor oversight.
  • Strong leadership, communication, and interpersonal skills.
  • Excellent organizational and time-management skills.
  • Proficiency in clinical trial management software and Microsoft Office Suite.
  • Ability to work independently and as part of a team.

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