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Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Associate Director, Alliance Management - eCOA

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timePrinceton, NJ, USA

About the Job

Requirements

  • A bachelor's degree or relevant experience is required.
  • A minimum of 5–7 years of industry experience in pharmaceutical, biotechnology, or contract research organization settings is required.
  • Neuroscience clinical development experience is required, including a strong understanding of neuroscience study designs, patient populations, endpoints, and operational complexities.
  • Hands-on end-to-end experience managing electronic Clinical Outcome Assessment (eCOA) across the clinical trial lifecycle is required, including strategy, instrument and language licensing, implementation, configuration and validation, integrations, site and patient enablement, data delivery and reconciliation, change control, issue and risk management, vendor governance, and study closeout.
  • Strong project management and stakeholder management skills are required.
  • Experience working directly with Contract Service Providers, investigators, customers, opinion leaders, and professional staff, as well as broad exposure to the pharmaceutical industry, is required.
  • Ability to communicate effectively with diverse audiences at multiple company levels is required.
  • Demonstrated ability to manage and work with cross-functional and global, cross-country teams in a complex, changing environment is required.

Responsibilities

  • Coordinate with the partner counterpart on overall portfolio delivery, including timely execution of the book of work in accordance with the Master Services Agreement and Quality Agreement.
  • Provide end-to-end oversight of eCOA services across neuroscience clinical programs, including vendor strategy and selection, study start-up, instrument licensing and implementation, system configuration and validation, site and patient deployment, data quality and delivery, change control, issue escalation, closeout, and lessons learned.
  • Co-lead and drive effective governance meetings, including Operational and Strategic Management Committees, and additional project meetings as needed.
  • Liaise with internal clinical teams, regional colleagues, subject matter experts, stakeholders in other functions, and the partner organization to embed the operational model and identify and resolve issues and gaps.
  • Drive collaborative continuous-improvement initiatives with the partner to streamline and improve operational processes.
  • Drive communication and training to support adherence to the operating model and efficient execution.
  • Collaborate with the BMS quality organization and partner to drive effective quality management of outsourced trials.
  • Support Master Services Agreement and partnership contract negotiations as needed.
  • Collaborate with other BMS business units that outsource clinical trials to align information and best practices and standardize processes where applicable.
  • Provide an outsourcing perspective, proactively consider impacts on outsourced studies from BMS processes and requirements, and facilitate partner change management for associated process revisions.
  • Ensure appropriate communication with the development organization and stakeholders regarding outsourcing strategies and activities.

Desired Qualifications

  • Scientific, financial, and business problem-solving experience is desired.
  • Ability to review and negotiate contracts is preferred.

About the Company

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Bristol Myers Squibb discovers, develops and sells prescription medicines for serious illnesses, including cancer, blood disorders, immune diseases and heart disease, for patients treated by doctors and hospitals around the world. Its best-known drug is Opdivo, an immunotherapy that helps the body's own immune system find and attack many kinds of cancer. Researchers develop drug candidates in its labs or bring them in through acquisitions and partnerships, then test them in clinical trials to win regulatory approval. The company makes and markets the approved medicines and earns its revenue from sales of patent-protected drugs. Its roots go back to a business founded in 1887, and it is based in Lawrence Township, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Lawrence Township, NJ
Founded
1887

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