APM/PM - Late Phase - Brillex Clinical Research

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.