BeOne 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.
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
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, 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
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. 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 because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].
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