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.

PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION

Language Requirement: Fluent English and Portuguese. Spanish is a plus.

Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology

 

General Description:

The CRA will assume the role of a primary CRA. The CRA will conduct site visits (i.e., PSSV, SIV, IMV, COV) and function as the site manager. The CRA is responsible to build and maintain relationships with key site personnel and ensure an effective line of communication. The CRA will also monitor data quality and patient safety through monitoring and site education. CRAs are to complete all aspects of the clinical monitoring process in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.

Essential Functions:

Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devicesConduct site visits to determine protocol and regulatory compliance, and prepare required documentationDevelop collaborative relationships with investigative sites, and study vendorsProvide protocol and related study training to assigned clinical study sites  Attend disease indication and/or project specific training, as requiredMaintain oversight of site performance by tracking metrics for enrollment, data entry into Case Report Forms (CRFs), protocol deviation trends, and overall site issuesServe as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issuesCommunicate site performance to the Clinical Study Team (CST) Perform study-specific training with project teamPerform Serious Adverse Event (SAE) reconciliation and work with study sites to resolve discrepanciesCollaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.).Attend regional investigator meeting and site booster visits, as required Provide audit/inspection preparation support to clinical study sites and ensure quality issues or findings are followed to resolution, as needed Assist with other assigned clinical responsibilities within scope of role, as required

Minimum Requirements – Education and Experience:

BS/BA in a relevant scientific discipline and minimum of 2+ years of relevant Clinical Operations experience, and minimum of 1+ years of monitoring

experience. Experience in global oncology trials preferred.

Other Qualifications:

Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines Excellent communication and interpersonal skills Excellent organizational skills and ability to prioritize and multi-taskFluent in English (writing and speaking) 

Supervisory Responsibilities: 

Provides site level management for established protocols and portfolio under general supervisionProvides mentoring/support to CRAs for CRA related topicsCo-monitoring with CRAs and support site visits, as needed

Travel: Up to 70& travel

Computer Skills:  

Efficient in Microsoft Word, Excel, PowerPoint and Outlook Familiar with industry CTMS and data management systems

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BeiGene Global Competencies

When 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

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.