.BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.Only Applicants with a valid work permit will be considered - we do not provide sponsorship for this position.General Description Role will support the study team with Clinical Operations tasks, and/or assist in ensuring compliance including completeness and quality checks of the trial master file (TMF).Demonstrates basic clinical operations knowledge and strong organizational skills.Implements best practices and shares lessons learned with team and other colleagues, as appropriate.Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs.The Junior Associate role in Clinical Operations is an entry-level position.Clinical Operations Support To Study Teams This job description provides the broadest description of potential assigned activities. There will be specific roles and responsibilities assigned from this Job Description, according to project assignment(s). As such, responsibilities will include some of the following activities, but may not be limited to:Assists in development of clinical trial documents, manuals, trackers (may support informed consent development and version tracking).Preparation and documentation of internal and external meetings by preparing agendas and minutes.Maintaining clinical operations tracking tools e.G. enrollment, CTMS, laboratory samples, monitoring visits, site status, support in HA and IRB/EC submissions; support study team withsite start-up preparation, EC fee application and tracking, drug supply, data cleaning, vendor tracking, training, risk management, study goals, investigator contracts and payments; support study team withsite level payments and invoices, invoice reconciliation and budget tracking.Support reporting for Senior Management updates.Clinicaltrials.Gov and/or local registry posting and maintenance.Site materials and equipment: support study team with distribution of site materials and equipment, document printing, shipment, and other administrative work.Administrative: business and department office administration support if required.Trial Master File (TMF) Support Clinical Operation Managers (COMs) with the setup, maintenance, and close out of TMF.Coordinate document collection from others as appropriate.Upload documents to eTMF or other applicable document repositories ensuring quality documents are uploaded.Support TMF completeness activities.Follow TMF Plans, applicable SOPs, ICH/GCP guidelines, and regulatory requirements.Support actions ensuring the TMF is submission/inspection ready.Develop successful cross-functional relationships with internal and external TMF stakeholders
