Description:
We are addressing the challenges facing the research and development of novel compounds in Oncology and are dedicated to positively impacting the health and lives of patients around the world. If you take a consultative approach to trial management, proving to be a valuable partner in the trial operational delivery process, don't miss exploring working with us.
About You
- You love having responsibility and a say in how clinical trials are run
- You plan ahead, but have alternative options and a flexible approach
- You are client focused
- You are well organised and able to manage timelines and shifting priorities, without sacrificing quality.
- You communicate clearly, often and concisely and know that your role is crucial in keeping the trial running smoothly
- You are a master at identifying any risks that threaten projects and handle them resolutely
- You thrive and work with autonomy and ownership to deliver successful outcomes
The day-to-day role, and how we will support your continued growth:
- Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
- Successful execution of assigned trials and ensuring completion of trial deliverables
- Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members
- Mentoring and training of team members
- Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor
- Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities
- Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction
Qualifications
Minimum Required:
- Bachelor’s degree or equivalent combination of education/experience in science or health-related field, including experience in the field of oncology
Other Required
- Demonstrable experience leading clinical aspects of your studies across multiple countries in a CRO / Pharma or Biotech company (in a dedicated 'clinical lead' role).
- Significant clinical trial management experience in the area of oncology
- Working knowledge of GCP/ICH guidelines and the clinical development process
- Availability for domestic and international travel including overnight stays
- Must be able to communicate effectively in the English language
Skills
- Demonstrated computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
- Demonstrated ability to develop positive working relationships with internal and external organizations
- Demonstrates core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan