Overview
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
YesComputer Skills
AdvancedEducation Required
Bachelor's degree in engineering or biotech industry7+ years' experience in biotech / pharmaceutical environmentMinimum of four years in management role and functional leadershipOther Qualifications
Fluent in English both for verbal and writtenAbility to work independently, under pressure meeting tight deadlines, demonstrating high level of initiative and flexibilityExcellent organizational and analytical skillsHigh attention to detail and accuracyProven problem-solving skillsDemonstrated knowledge of clinical and pharmaceutical drug development processExperience 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 interoperabilityCompetence with project management skillsExcellent communication and interpersonal skillsDemonstrated ability to work effectively with internal groups and external partnersAbility to work in a global team environmentAbility to interact effectively with all levels of managementTravel
None to MinimalBeOne 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 ClarityGlobal 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 TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking / Data AnalysisFinancial ExcellenceCommunicates with ClaritySalary Range : $137,600.00 - $182,600.00 annually
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 accommodationsus@beonemed.com.
J-18808-Ljbffr