Senior Clinical Trial Manager

Role Overview

• Serve as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
• Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams.
• Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report.
• Collaborate with central study team and local stakeholders as applicable for final selection of sites to participate in trial.
• Ensure local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations.
• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress.
• Initiate corrective and preventive actions (CAPA) when the trial deviates from plans and communicate study progress and issues to study management teams and Quality & Compliance team.
• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Deliver competent vendor management at the country level to support the study and submit requests for vendor services and support vendor selection as applicable.
• Ensure high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training, when needed.
• Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines.
• Keep the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals in cooperation with the local Start Up team.

Requirements

• BA/BS degree
• Degree in a health or science related field
• 3
• 5+ years of trial end to end management experience
• Start-up & Database Locks/Cleaning experience preferred
• Hematology Oncology experience required
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
• Strong IT skills in appropriate software and company systems
• Proficient in speaking and writing the country language and English
• Good written and oral communication skills as appropriate
• To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Tech Stack

• Google Cloud Platform

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways