Program Lead II CDSO

hace 14 horas


Ciudad de México, Ciudad de México Allergan A tiempo completo

Job Summary

AbbVie is seeking a highly skilled Program Lead II CDSO to join our Clinical Data Strategy & Operations team. As a key member of our team, you will be responsible for leading clinical trials from initiation to completion, ensuring successful delivery against program- and study-level accountabilities assigned to Data and Statistical Sciences.

Key Responsibilities

  • Aligns DSS study teams with program- and study-level strategies.
  • Leads the DSS Study Team and represents DS as a member of the cross-functional study team.
  • Acts as single point of contact and accountable operational lead from DSS.
  • Coordinates associated DSS study teams to meet operational objectives.
  • Engages and connects global functional and cross-functional teams at the study level.
  • Utilizes operational analytics and project management tools to optimize execution of programs and studies.
  • Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.
  • Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards.
  • Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development.
  • Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance.
  • Responsible for coaching and mentoring team members.
  • Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives.

Qualifications

  • Bachelor's degree in scientific or related fields. Advanced degree preferred.
  • Minimum 6 years of pharma / clinical research / data management / health care experience or extensive project management experience (and / or applicable work experience).
  • In-depth understanding of clinical trial processes and clinical technology.
  • Demonstrated performance as a functional leader.
  • Demonstrated ability to influence others without direct authority.
  • Demonstrated ability to successfully coach / mentor in a matrix environment.
  • Demonstrated effective communication skills.
  • Demonstrated effective analytical skills.
  • English Language Fluency: Demonstrated proficiency in verbal, written, and conversational English, with the ability to effectively communicate clearly and concisely in all forms of communication.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our short-term incentive programs.
  • This job is eligible to participate in our long-term incentive programs.

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