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Senior Manager, CDM Systems Administrator is responsible for leading and oversight of Data Management systems including Oracle LSH/DMW, Medidata Rave and any systems onboarded within data management department.

Essential Functions of the Job:

+ Accountable for the management and development of EDC Administrator team

+ Support with 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 that impact data management systems

+ Develop and maintain user access management documents to maintain compliance

+ Function as an EDC Systems Support SME for providing guidance and best practices to DM, Clinical teams and other cross functional groups

+ Responsible for the resolution and escalation of user access issues, tool issues, testing needs, enhancement requests

+ Responsible for contributing/supporting integration of different clinical systems and similar initiatives that enhance efficiencies and quality of data management processes

+ Provide EDC technical support to facilitate clinical study timelines and deliverables

+ Responsible for supporting development, reviewing and approving systems related documentation

+ Oversee the EDC Administrator role to support operational deliverables under Study Set Up, Study Maintenance, Study Conduct and Study Close Out

+ Conduct User Acceptance Testing on EDC system version upgrades, patches and integrations

+ Support technical systems access requests for all users including those that may include outsourced trials, CROs and offshore partners resources

+ Provide oversight of Help Desk Support Management by being an internal escalation point for reviewing and providing feedback on help desk tickets

+ Perform all other related duties as assigned

+ Direct reports 4-6 EDC Admins

Supervisory Responsibilities:

+ Yes

Computer Skills:

+ Advanced

Education Required:

+ 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

Other Qualifications:

+ 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

Travel:

+ None to Minimal

BeOne 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 Teamwork

+ Provides and Solicits Honest and Actionable Feedback

+ Self-Awareness

+ Acts Inclusively

+ Demonstrates Initiative

+ Entrepreneurial Mindset

+ Continuous Learning

+ Embraces Change

+ Results-Oriented

+ Analytical Thinking/Data Analysis

+ Financial Excellence

+ Communicates with Clarity

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.