Clinical Operations Director

hace 1 mes

Buenos Aires, Buenos Aires C.F., Argentina AbbVie A tiempo completo

About the Role:


The Clinical Operations Manager at AbbVie will be responsible for overseeing site-related study execution, ensuring timely and within-budget completion of assigned projects. This includes country and site feasibility, contract negotiation, regulatory submissions, issue management, relationship building, monitoring, and site closure.



Key Responsibilities

  • Accountable for all activities of site-related study execution, including start-up, execution, and close-out.
  • Oversee site evaluation and selection, contracts and budget negotiation, regulatory submissions, issue management, relationship management, monitoring, and site closure.
  • Ensure adherence to federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and quality standards in conducting clinical research.
  • Stay abreast of new and evolving local regulations, guidelines, and policies; monitor regulatory reforms and industry trends within the country/district, providing impact analysis of significant changes affecting clinical studies.
  • Ensure audit and inspection readiness of assigned sites; advise on pre-audit GCP requirements, prepare and follow up on site and system audits, CAPA preparation, and implementation.
  • Responsible for resource management for the assigned team, providing ongoing assessment and input towards resource needs and allocating resources in alignment with AbbVie research goals, priorities, and specific study timelines.
  • Identify and communicate issues impacting resource allocation, provide solutions, and drive continuous improvement and simplicity in process and approach.
  • Responsible for talent acquisition and retention, performance management, growth, and development.
  • May serve as a key point of contact in the country/district for one or more studies with higher complexity, updating Impact/Tesla with country-level information.
  • Collaborate with stakeholders to achieve proactive, strategic, and tactical success throughout the study planning, execution, and closeout phases, leading to World Class clinical trials.
  • Accountable for resource management and deliverables of the assigned Remote Data Review (RDR) team, collaborating with stakeholders to ensure appropriate study-specific training and assignment of staff to studies.


Qualifications and Requirements

  • Bachelor's degree or equivalent, health-related (e.g., medical, scientific, nursing, pharmacy) preferred.
  • Minimum 3 years of site monitoring experience.
  • Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives, driving smart decision-making.
  • Excellent interpersonal skills, ability to communicate persuasively and with clarity, flexibility, adaptability to changing requirements, resourcefulness, and creativity.
  • Demonstrated business ethics and integrity.


Additional Information

AbbVie is an equal opportunity employer 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 due to 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, protected veteran status, or any other legally protected group status.


US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html


US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html


This role offers a competitive salary range of $110,000 - $150,000 per annum, depending on location and experience. If you are a highly motivated and organized individual looking for a challenging role in clinical operations, we encourage you to apply.

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