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Senior Manager, eCOA Operations

2 months ago

Madison, New Jersey, United States Bristol-Myers Squibb Full time
About Us

At Bristol Myers Squibb, we believe in the power of meaningful work. Our environment is anything but ordinary, where every role contributes to groundbreaking advancements in healthcare.

From enhancing production efficiency to pioneering cell therapy innovations, our work has a profound impact on patients' lives and the careers of our dedicated team members.

We offer unique opportunities for growth and development, supported by diverse, high-performing teams.

Join us to take your career to new heights.


Position Overview

The Senior Manager, eCOA Operations plays a pivotal role in the implementation of electronic Clinical Outcome Assessments (eCOA) within clinical trials, directly influencing the Bristol Myers Squibb research and development pipeline. This leadership position is integral to ensuring the operational success of eCOA initiatives.

Key Responsibilities
  • Lead the comprehensive operationalization of eCOA, collaborating with vendors and study teams to guarantee effective study execution.
  • Assess project workloads related to eCOA and allocate resources accordingly, while also forecasting future requirements.
  • Enhance processes and documentation to streamline eCOA implementation.
  • Address and resolve eCOA-related challenges during study execution in partnership with study teams and vendors.
  • Participate in governance activities to ensure effective vendor collaboration and timely issue resolution.
  • Oversee quality management of external partners conducting eCOA tasks on behalf of Bristol Myers Squibb.
  • Provide mentorship and professional development opportunities for team members, fostering high-quality performance.
  • Maintain procedural documentation to align with industry standards and regulatory expectations.
  • Proactively identify and resolve complex issues, employing clear communication and collaborative approaches.
  • Drive continuous improvement initiatives to establish a leading eCOA capability.
  • Represent the function during Health Authority inspections and internal audits, ensuring thorough preparation and follow-up.
  • Engage and motivate employees by effectively communicating organizational goals and critical information.
  • Foster a workplace culture that prioritizes diversity, integrity, and accountability.
  • Build strong relationships with stakeholders across Global Data Management and eCOA vendors.

Qualifications
  • Bachelor's degree required; advanced degree preferred.
  • A minimum of 7 years of experience in global clinical trials, specifically with eCOA processes and implementation.
  • Proven ability to lead through influence and navigate complex organizational structures.
  • In-depth knowledge of the drug development lifecycle, particularly in clinical trial execution and eCOA operationalization.
  • Strong technical expertise in eCOA methodologies and clinical data management.
  • Familiarity with GCP/ICH guidelines and industry-leading tools.
  • Demonstrated ability to resolve complex challenges and drive initiatives to successful completion.
  • Excellent communication and leadership skills to inspire a geographically diverse team.

Travel Requirements

Occasional travel may be necessary.


Our Commitment

Bristol Myers Squibb is dedicated to fostering an inclusive environment where every employee can thrive. We encourage individuals from diverse backgrounds to apply and contribute to our mission of transforming patients' lives through science.