Senior Manager, CDM Systems Administrator

Role Summary

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.

Responsibilities

• 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

Qualifications

• 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

Skills

• Advanced computer skills
• 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

Education

• Bachelor’s degree in engineering or biotech industry

Additional Requirements

• Travel: None to Minimal