Clinical Study Operations Manager

hace 4 semanas


Xico, México Abbvie Inc A tiempo completo

Job Summary

AbbVie Inc is seeking a highly skilled Clinical Study Operations Manager to join our team. As a key member of our Clinical Study Leadership team, you will be responsible for the direct management of a cohesive regional team of Study Management Associates (SMAs).

Key Responsibilities

  • Drive for best-in-class study execution by creating a globally inclusive, innovative, empowering environment built around skill enhancement, strategic/critical thinking, and continuous learning.
  • Performance management of direct reports, including but not limited to collecting stakeholder feedback, conducting and documenting performance discussions, setting clear and measurable goals, performing goal progress updates, and other business HR-related requirements.
  • Provide SMAs with the opportunity of professional success and enable growth into future leadership roles through mentoring, individualized development plans, and providing stretch opportunities.
  • Support business continuity, shifting needs, and organizational deliverables across the portfolio through efficient, flexible, and strategic resource management including both short- and long-range demand, evolving geographic footprints, all aspects of vacancy management, and individual growth and development.
  • Ensure awareness and adherence of direct reports to corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines by prompting on-time completion and reinforce expectations of required training.
  • Contribute to the development of Quality Systems Documents (QSDs) and the training curriculum for roles within SMAO.
  • Develop and nurture relationships with direct reports and partnerships with cross-functional stakeholders to support implementation of aggressive execution strategies and drive results across study teams.
  • Support organizational efficiencies, process improvements, and best practices by contributing to SMAO/CSL/CDO workstreams and/or initiatives.
  • Mentor peer SMAO Line Managers, as needed.

Qualifications
  • Bachelor's Degree required, degree in health care or scientific field preferred.
  • Minimum of 8 years of clinical research experience, with 6+ years of relevant study operations management experience.
  • At least 3 years of direct people management experience.
  • Excellent interpersonal skills including the ability to influence, communicate persuasively and with clarity, align, build trust, lead while respectfully challenging, and form strong relationships with stakeholders within a cross-functional, global, remote/virtual team environment.
  • Successful coaching/mentoring, directly or in a matrix environment.
  • Strong analytical and critical thinking skills, the ability to evaluate complex issues from multiple perspectives and drive smart decision making.
  • Ability to adapt easily to rapidly changing needs, requirements and situations while modeling AbbVie's leadership attributes.
  • Experience in drug development/clinical operations including an advanced working knowledge of ICH and GCP guidelines and operational understanding of the global regulatory environment.
  • Demonstrated success in study execution across global geographies and/or multiple therapeutic areas and managing multiple priorities in a fast-paced environment.

About AbbVie
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit here. US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more.

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