工作内容: Global Study Associate Director
We are currently hiring a Global Study Associate Director for our client. Our client is a global pharmaceutical company leading a revolution in oncology with one of the most diverse portfolios in the industry producing medicines and vaccines. The company has an inclusive culture that champions diversity, collaboration and is committed to lifelong learning, growth, and development.
The Global Study Associate Director will be backed by leadership and empowered at every level to prioritize and make bold moves. The company’s pioneering approach is identifying and treating patients earlier, focusing on early-stage cancer trials and listening and evolving based on their needs. The successful incumbent will be joining a dedicated Haematology team that is growing fast and building a strong track record of success.
- Responsible for leading a cross-functional study team to enable successful delivery of clinical studies from the onset of study specifications through to study archiving
- Mentor and empower a cross-functional team to operationally deliver defined clinical studies or assigned clinical project activities to time, cost, and appropriate quality in line with ICH/GCP and the company relevant SOPs
- Be the key point of contact to the CRO project manager to ensure delivery to time, quality, and cost; ensuring the company oversight of the CRO is defined and performed across relevant the company functions for outsourced studies
- Develop and maintain up to date study plans (e.g., global study management plan, monitoring plan, etc.) ensure study level performance against agreed upon plans, lead proactive risk and contingency planning, and raise issues as appropriate
- Provide input and hold accountability for the development of crucial study level documents (i.e., Clinical study Protocol)
- Select and lead vendors, handling their performance to ensure high quality, timely delivered services
- Ensure appropriate training is provided to the local teams, investigators, and site staff as well as vendor teams as needed, taking an active role in the Investigators/Monitoring Meetings
- Set initial operational study budget with the Clinical Program Team (CPT), and are responsible for study budget throughout the study, providing budget progress reports to leadership
- Ensure studies are always inspection-ready, according to ICH-GCP, the company SOP and relevant policies/guidelines
- Responsible for the completeness of the Trial Master File; being the primary Study Management point-of-contact in the event of an audit or inspection
- May be assigned responsibility for leadership or participation in non-drug project work including applying process improvements methods and to inspire change for new ways to work
- You are responsible for collecting and reporting Adverse Events in accordance with the company policies and procedures
- University degree (or equivalent), preferably in medical or biological sciences or related to clinical research (Advanced degree is preferred)
- At least 7 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g., CRO) including clinical trial leadership experience (preferably on global trials)
- Solid understanding of clinical operations and study management processes, along with experience in various phases of development and therapy areas
- A minimum of 2 years clinical project management experience. PMP certification is desirable
- Possess strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, empowering critical thinking, problem solving, and influencing
- Significant experience managing study budgets
- Strong communication skills with the ability to build positive relationships, including vendor leadership skills
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