Senior Manager, Clinical Data Management

📋 Description

• Oversee Clinical Data Management (CDM) activities across projects within the biosimilars operational unit in collaboration with a CRO under a fully outsourced business model.

• Direct the CDM function and system integrations at Amgen and with CROs/external partners to guarantee timely delivery of study data.

• Manage biosimilars CDM initiatives and programs, including system infrastructure, integration, and the upkeep of SharePoint site permissions and content.

• Contribute to the establishment of group goals and objectives.

• Execute CDM strategies and support the implementation of broader biosimilar objectives and tactics.

• Aid in the development, review, implementation, and enforcement of biosimilars Standard Operating Procedures (SOPs).

• Ensure the provision of high-quality clinical trial data within established timelines.

• Verify that CDM processes and systems comply with regulatory and business standards.

• Assist with contracts and budgets related to CROs.

⛳️ Requirements

• Doctorate degree with 2 years of clinical data management experience OR Master’s degree with 4 years of clinical data management experience OR Bachelor’s degree with 6 years of clinical data management experience OR Associate’s degree with 10 years of clinical data management experience OR High school diploma/GED with 12 years of clinical data management experience, including direct people management or leadership experience leading teams, projects, or programs, or directing resource allocation.

• Master’s degree or equivalent in life sciences, computer science, business administration, or a related field.

• 10 years of experience in data management within the Pharmaceutical or Biotech industry.

• 3+ years of experience in a global organization.

• Prior experience overseeing or working with external clinical research vendors (CROs, central labs, imaging vendors, etc.).

🏝️ Benefits

• A comprehensive employee benefits package, featuring a Retirement and Savings Plan with substantial 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 feasible.