At Arbutus we have a vision: to cure chronic Hepatitis B virus (HBV). We have a dedicated and innovative team and we are uniquely positioned to transform the HBV treatment landscape. We are developing a portfolio of drug candidates with multiple mechanisms of action that we believe will result in a combination therapy to cure HBV.
Reporting to the Director, Clinical Operations, the Clinical Study Manager oversees the design, planning, implementation and monitoring of assigned Clinical Studies.
Duties and responsibilities will include:
• Manages and coordinates all aspects of assigned trials to ensure they are conducted in accordance with established protocols Company standards and ICH/GCP guidelines.
• Monitors all study activities and results taking/recommending corrective action to ensure that all assigned studies are completed on time and on budget.
• Assists in the design and writing of clinical protocols for assigned projects.
• Develops and tracks study budgets and timelines to meet all milestones.
• Tracks and reports on study metrics and keeps abreast of study developments.
• Identifies and recommends vendors and oversees contracting process in order to ensure study requirements are met.
• Coordinates CRO and vendor contracting process and manages CRO's and vendors to ensure stated objectives and deliverables are met.
• Provides assistance to Regulatory Affairs as necessary for filing and other necessary compliance requirements.
• Collects and reviews clinical data and results and ensures reports and summary data are prepared and disseminated appropriately.
• Determines information and reporting requirements for assigned studies designing forms and procedures, as necessary.
• Other related duties as assigned.
• BSc in a related Life Sciences Discipline, Master’s degree preferred, with a minimum of 5 years experience in a senior clinical operations role or an equivalent combination of education and experience.
• Must have direct experience overseeing clinical studies in the biotech/pharmaceutical industry.
• Excellent ability to track and organize clinical trials.
• Experience with data analysis, report and protocol writing.
• Ability to work effectively independently or as part of a team.
• Comfortable managing multiple projects and ability to adapt to changing priorities.
• Excellent knowledge and ability with MS Office software; advanced user level in MS Word, Excel and Power Point.
• Strong understanding of Clinical Development.
• Proven project management skills including budgeting, scheduling, risk management and project tracking.