Lead and provide oversight of Data Management systems including Oracle LSH/DMW, Medidata Rave and systems onboarded to the data management department
Accountable for the management and development of EDC Administrator team
Support EDC admin activities as well as LSH/DMW activities
Manage user, site and subject administration support to clinical applications utilized by Clinical Data Management group
Collaborate with R&D data governance groups and IT groups in implementation of MDM and downstream processes impacting data management systems
Develop and maintain user access management documents to maintain compliance
Function as an EDC Systems Support SME providing guidance and best practices to DM, Clinical teams and other cross functional groups
Resolve and escalate user access issues, tool issues, testing needs, and enhancement requests
Contribute to integration of different clinical systems to enhance efficiencies and data quality
Provide EDC technical support to facilitate clinical study timelines and deliverables
Support development, review and approval of systems-related documentation
Oversee EDC Administrator role to support Study Set Up, Study Maintenance, Study Conduct and Study Close Out operational deliverables
Conduct User Acceptance Testing on EDC system version upgrades, patches and integrations
Support technical systems access requests for all users including outsourced trials, CROs and offshore partner resources
Provide oversight of Help Desk Support Management as internal escalation point
Perform all other related duties as assigned
Requirements
Bachelor’s degree in engineering or biotech industry
7+ years’ experience in biotech/pharmaceutical environment
Minimum of four years in management role and functional leadership
Fluent in English both for verbal and written
Ability to work independently, under pressure meeting tight deadlines, demonstrating high level of initiative and flexibility
Excellent organizational and analytical skills
High attention to detail and accuracy
Proven problem-solving skills
Demonstrated knowledge of clinical and pharmaceutical drug development process
Experience of clinical databases, clinical data management systems and electronic data capture (EDC)
Knowledge and understanding of clinical database design / study build / data validation and system interoperability
Competence with project management skills
Excellent communication and interpersonal skills
Demonstrated ability to work effectively with internal groups and external partners
Ability to work in a global team environment
Ability to interact effectively with all levels of management
Computer Skills: Advanced
Experience with Oracle LSH/DMW and Medidata Rave (EDC systems)
Travel: None to Minimal
Benefits
Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan
All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock (discretionary equity awards)
Employee Stock Purchase Plan
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data managementEDC administrationclinical databaseselectronic data captureclinical data management systemsclinical database designdata validationsystem interoperabilityproject managementuser acceptance testing
Soft skills
leadershiporganizational skillsanalytical skillsproblem-solvingcommunication skillsinterpersonal skillsindependenceflexibilityattention to detailability to work under pressure