Bristol-Myers Squibb Company

Regional Clinical Compliance Lead

Location
Princeton, NJ, US
Posted
Feb 10, 2019
Ref
R1511252_EN
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Responsibilities:

This role will report to the Director of Regional Clinical Compliance who is a member of the Global Clinical Compliance & Continuous Improvement (GCCCI) leadership team under Global Clinical Operations (GCO).

Responsibilities will include:

In partnership with the Regional Clinical Operations and Global Quality, mainly support the regional study teams and sites in Latin America to assure inspection and audit readiness at all times. Provide on-site support prior to, and during internal audits. Provide support for on-site and sponsor inspections by Health Authorities, and coordinate these inspections as necessary. In partnership with the Regional Clinical Operations teams, provide appropriate continued oversight to study teams. Work closely with the Clinical Quality and Risk Management team and help implement elements of the Quality Management System: identify emerging and significant risks, provide support for root cause analyses and mitigation strategies, ensure documentation and appropriately notify/escalate to the right level of Governance. Provide CAPA leadership by coordinating CAPA development and approval, as well as implementation and tracking of effectiveness. Partner with the Clinical Training, Process and Continuous Improvement organization to identify gaps/needs in training at the regional level, and providing local training support/coordination as needed. As the scope of Global Clinical Operations includes registrational and non registrational data generation (NRDG), regional clinical compliance activities will span across Phase I through IV studies including Investigator-Sponsored Research and Real World Data Generation. In that context, partner with GCO NRDG teams to enhance GCP compliance for NRDG in partnership with Regional/Country Medical. Work with management and Global Quality to foster a regional, cross functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times, and Growth Mindset.

Qualifications
  • A minimum of a Bachelor's Degree or equivalent is required. A degree in Life Sciences or equivalent is preferred. At least 5 years of experience in clinical trial operations and/or Good Clinical Practice is required. Fluency in Spanish and/or Portuguese is required.
  • Good understanding of regional/country Health Authority regulations, of the drug development process and clinical operations, experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions.
  • Experience in matrix management and training is desirable with the ability to engage and inspire others. Good communication skills with a proven ability to effectively engage and manage key internal stakeholders (in various functions and geographies) as well as external stakeholders (including Health Authorities). Good presentation and negotiation skills with the ability to timely resolve conflict in a constructive manner.
  • Ability to manage multiple projects simultaneously to ensure timely, on-budget execution of tasks. Attention to detail with excellent planning, time management and organizational skills.
  • The candidate will demonstrate the ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with speed, accountability and integrity, and to have fun along the way.
  • This role will be based in central New Jersey and require significant domestic and international travel up to 50%.