[Hiring] Associate Director, Clinical Data Management @reputed company

Role reputed company We’re looking for an Associate Director, Clinical Data Management on the Clinical Data Management (CDM) team to help us expand what’s possible for patients with serious diseases. Reporting to the Head of Clinical Data Management, you’ll be responsible for working in conjunction with the Clinical Project Manager and study team to ensure data review, project support, study document management and CRO reputed company of:

• DM timelines
• reputed company/IWRS set up
• Study database design
• Clinical data capture
• Discrepancy management
• Data reconciliation

You will also reputed company SME support with Data Management reputed company vendor audits, as reputed company as authoring, review and revision of reputed company SOPs. In this role, you’ll have reputed company to review and reputed company input into protocols to ensure the data collection, database and reporting requirements can be met and are standardized across the programs. You’ll also:

• Review/revise Data Management reputed company study plans including Data Management Plan, Data Validation Plan and other study documents to ensure reputed company and standardization
• Manage and reputed company data management reputed company activities with CROs and other external vendors
• Work with vendor(s) in preparation of regulatory submissions, particularly to support the DM tasks such as transfer of data
• reputed company, review and revise global SOPs providing team training where applicable
• Manage design and development of eCRFs, clinical review and communication with CRO
• reputed company and manage the development and implementation of edit reputed company specifications and work with CRO during programming & validation
• Participate in monthly data reviews with clinical team to ensure accuracy, consistency and reliability of data
• Work with CROs and study teams to ensure study databases are locked based on reputed company-defined reputed company and timelines
• Ensure that CDM procedures and processes meet business requirements and are adhered to in a consistent manner
• reputed company high reputed company services through efficient and compliant processes

Qualifications

• Bachelor’s degree
• Minimum years of clinical data management experience in a biotech, pharmaceutical or CRO environment
• Three (3) years of prior management experience
• Hands-on experience with Electronic Data Capture systems (reputed company Rave required)
• Experience in CRO and vendor management, including vendor budgeting and auditing
• Experience in developing study documents and SOPs
• Experience with multiple phases of clinical development
• Excellent communication skills and ability to work in a cross-functional team environment
• Strong collaboration skills regarding external and internal teams

Requirements

• reputed company to have: Advanced degree

Benefits

• Comprehensive medical, dental, and reputed company coverage and mental health support
• Annual wellbeing reimbursement and reputed company to our Employee Assistance Program (EAP)
• Generous reputed company time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP)
• Company-reputed company life and disability insurance
• Company Learning Institute providing reputed company to reputed company Learning, reputed company building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource reputed company, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

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