Description
Main Responsibilities:* In association with the Head of Clinical Operations, lead the implementation and on-time execution of all clinical trials assigned * Work with senior managers and key opinion leaders to ensure the delivery of clinical trial activities.
* Assist the Head of Clinical Operations to manage internal/external resources and budgets to deliver the agreed clinical trial plan * Work closely with the Head of QA on all audit issues and deliverables. Review audit reports and liaise with site members to resolve on-site observations and close out on-site company audits.
* Assist in training CRO CRAs and CTMs, site staff, external healthcare professionals and vendor employees as required.
* Continuously improve internal procedures, ensuring compliance with latest GCP, ICH and regulatory guidelines.
* Identify and escalate any safety issues arising during the clinical trials.
* Write and implement SOPs, ensuring adherence for quality and audit accountability.
Requirements:
* Experience as SCRA / CTM and study lead for global oncology clinical trial programs across international boundaries * Project management skills to ensure on-time, high quality delivery of clinical trials within budget.
* A strong communicator (both verbal and written) with confidence and experience to lead discussions with senior managers, key opinion leaders and external agencies.
* Skill in dealing with external vendors (CROs).
* Expertise in audit report accountability; ability to review audit reports and liaise with site members to resolve on site observations and close out on site company audits.
* Experience with co-monitoring and parallel monitoring * Proficient in revising and creating Standard Operating Procedures
* Cross-functional team player with the ability to work unsupervised.
* A Life Science degree or other relevant qualification.
* Minimum 5 years of experience at a senior level in clinical research.
To find out more about Real please visit www.realstaffing.com