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Amgen

Makes biotech medicines for serious illnesses

Senior Manager Program Data Delivery

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeHyderabad, Telangana, IndiaNo salary listedIn-person

About the Job

Requirements

  • A doctorate degree plus 2 years of experience in life sciences, computer sciences, or business administration; or a master’s degree plus 6 years; or a bachelor’s degree plus 8 years; or an associate’s degree plus 10 years; or a high school diploma or GED plus 12 years.
  • At least 2 years of experience directly managing people and/or leadership experience leading teams, projects, or programs, or directing resource allocation; this may run concurrently with the required technical experience.
  • Experience managing data on biopharmaceutical clinical research, including 5 years in data management as part of 7 years of experience in life sciences or a medically related field.
  • Experience working across clinical trial teams in multiple geographies to deliver global clinical trials.
  • Experience managing data collection and oversight with external vendors, including contract research organizations, central laboratories, and imaging vendors.
  • Experience with risk-based monitoring models, risk-based quality management, and/or clinical site management.
  • Ability to manage study deliverables, budgets, timelines, and performance metrics to optimize trial execution.
  • Ability to identify operational risks based on protocol design and implement mitigation strategies; identify and manage study issues, communicating or escalating them appropriately.
  • Experience overseeing study budgets and financial operations, reviewing and approving site expenditures, and optimizing resource allocation for cost efficiency.
  • Ability to interpret clinical and operational data to guide trial execution and identify study trends, and collaborate with biostatistics and data management to ensure data integrity.
  • Ability to identify and implement continuous improvement opportunities in team working practices.
  • Experience overseeing external vendors to deliver study requirements with high quality.
  • Experience developing and training teams on clinical trial materials to align with study protocols, regulatory requirements, and best practices.
  • Experience driving and executing change initiatives and ensuring adoption of new designs within the function.
  • Ability to manage, mentor, and develop professionals and support staff across functions and geographies, and foster collaboration across internal and external teams.
  • Strong collaboration and communication skills for engaging cross-functional teams, senior management, and external stakeholders.

Responsibilities

  • Build and maintain the program data delivery plan for all studies, key milestones, and inter-study dependencies.
  • Standardize program practices for data management plans, integrated data review plans, query management, reconciliation, and lock procedures.
  • Lead Study Data Delivery Leads and Central Monitors, provide direction, review their performance, and align their execution.
  • Review program metrics, including database build progress, query burden, reconciliation status, and risk signals, and ensure appropriate follow-through and closure.
  • Chair program-level issue reviews and coordinate cross-functional resolutions with Clinical Operations, Biostatistics, Safety, Systems, and vendors.
  • Coordinate program resources and surge support, including associates and functional service providers, to maintain critical-path progress.
  • Consolidate program risk registers and ensure mitigation plans are tracked through closure.
  • Prepare program data delivery status for governance, highlighting risks, decisions, and trade-offs.
  • Mentor study-level leads on planning, communication, stakeholder management, and execution.

Desired Qualifications

  • Experience working across clinical trial teams in multiple geographies to deliver global clinical trials.
  • Experience managing data collection and oversight with external vendors, including contract research organizations, central laboratories, and imaging vendors.
  • Experience with risk-based monitoring models, risk-based quality management, and/or clinical site management.

About the Company

Amgen

Makes biotech medicines for serious illnesses

Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.

Company size
10,001+
Company stage
IPO
Headquarters
Thousand Oaks, CA
Founded
1980

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