Regional Clinical Trial Management Associate
hace 1 mes
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.Job DescriptionOnly 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 skillsImplements best practices and shares lessons learned with team and other colleagues, as appropriateAdheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPsThe Junior Associate role in Clinical Operations is an entry level positionThis 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:Clinical Operations support to study teams:Support cross-functional clinical study teams from start-up through close-out: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 minutesMaintaining clinical operations tracking tools e.g.enrollmentCTMSlaboratory samplesmonitoring visitssite statussupport in HA and IRB/EC submissions; support study team with site start-up preparation, EC fee application and trackingdrug supplydata cleaningvendor trackingtrainingrisk managementstudy goalsinvestigator contracts and payments; support study team with site level payments and invoicesinvoice reconciliation and budget trackingSupport reporting for Senior Management updatesClinicaltrials.gov and/or local registry posting and maintenanceSite 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 requiredTrial 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 readyDevelop successful cross-functional relationships with internal and external TMF stakeholdersOversee documentation flow within projected timelines and determine course of action needed to prevent and remediate delays and errors with TMF compilationSupport COMs in monitoring and reporting on progress of the TMF to stakeholdersApply lessons learned and demonstrate continuous improvement of documentation management practices across study teamsPerform other TMF related tasks as needed.Mentoring Responsibilities: More senior members of the associate team may mentor junior associatesAssociates with experience in specific tasks may mentor other associates with less or no experience in these tasksEducation Required: Bachelor's degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* with minimum of 2 years of experience in clinical operations (Senior Associate).Bachelor's degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* with minimum of 1 year of experience in clinical operations (Associate).Bachelor's degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* (Junior Associate).
Entry level.
*Exceptions may be made on case-by-case basis where candidates demonstrate appropriate skill set for a role in Clinical Operations and awareness of the role.Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and OutlookOther Qualifications: Ability to work independently and effectively handle multiple priorities in a fast-paced environmentExcellent interpersonal skills, strong organizational skills and effective written and verbal communication skills across all levels within an organizationTravel: up to15% BeiGene Global CompetenciesWhen we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity
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