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Senior Manager, Clinical Data Management
AmgenManage Clinical Data Management activities within the biosimilars operational unit at Amgen. Lead CDM function and ensure timely study data delivery in collaboration with external partners.
About the role
Key responsibilities & impact- Manage Clinical Data Management (CDM) activities within and across projects within the biosimilars operational unit in partnership with a CRO in a fully outsourced business model
- Lead CDM function and system integrations at Amgen and CROs/external partners to ensure timely study data delivery
- Manage biosimilars CDM activities and program(s), including system infrastructure and integration and maintenance of SharePoint site permissions and content
- Input into group goals and objectives
- Implementing CDM strategies and assisting in implementation of wider biosimilar goals and strategies
- Assisting with development of, reviewing, implementing and enforcing biosimilars SOPs
- Ensuring delivery of quality clinical trial data, within agreed upon timelines
- Ensuring CDM processes/systems meet regulatory and business requirements
- Assist with CRO contracts and budgets
Requirements
What you’ll need- Doctorate degree and 2 years of clinical data management experience OR Master’s degree and 4 years of clinical data management experience OR Bachelor’s degree and 6 years clinical data management experience OR Associate’s degree and 10 years of clinical data management experience OR High school diploma / GED and 12 years of clinical data management experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Master's degree or equivalent in life science, computer science, business administration or related discipline
- 10 years of work experience in data management in the Pharmaceutical or Biotech arena
- 3+ years of experience in a global organization
- Previous experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
Benefits
Comp & perks- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical data managementdata managementsystem integrationSOP developmentquality assuranceregulatory complianceproject managementbudget managementdata deliverybiosimilars
Soft Skills
leadershipteam managementcommunicationcollaborationgoal settingproblem solvingorganizational skillsstrategic planningresource allocationinterpersonal skills