Clinical Operations Manager: Global Clinical Studies and Publication Leadership

hace 2 semanas

Xico, México Abbvie A tiempo completo

Job Summary:

We are seeking a highly skilled Clinical Operations Manager to lead the coordination of planning, implementation, and conduction of local and global clinical studies across Mexico. The successful candidate will be responsible for managing activities related to clinical investigations, publications, and evidence generation projects in accordance with Abbvie's business strategy.

About the Role:

  • Manage the execution of Post Marketing Observational Studies (PMSO) in accordance with all relevant processes, procedures, and applicable SOPs and Local regulations.
  • Establish evidence governance in collaboration with Market Access to develop local long-term evidence strategies implemented through tailored research plans.
  • Prepare CA (Competent Authority) and/or EC (Ethic Committee) documentation, ensure submissions and/or notifications are performed as applicable.
  • Customize and execute agreements, consent and assent forms, local monitoring plan and other documents for evidence generation projects.
  • Participate in the development of protocol and synopsis for evidence generation projects.
  • Actively participate in the amendment of all required documents of evidence generation projects.
  • Identify, evaluate, and recommend new/potential investigators/sites on an ongoing basis.
  • Participate in the selection process of investigation sites and principal investigators, ensuring the engagement of physicians and institutions of high scientific relevance and in accordance with the corporate strategy.
  • Plan, prepare, and conduct study site personnel on the protocol and applicable regulatory requirements.
  • Proactively identify issues that may impact enrollment and recruitment timelines, anticipating and identifying site issues that could affect Clinical Studies timelines and collaborating in developing alternative solutions.
  • Manage projects according to budget and report progress to budget.
  • Anticipate potential problems within a study and create contingency plans accordingly.
  • Review and approve monitoring visit reports and enrollment updates when required.
  • Ensure the management and tracking of all regulatory documents.
  • Lead the process of scientific publications in the affiliate, initiating, monitoring, and managing affiliate publication activities, and oversight of publication management.
  • Identify, evaluate, and recommend new/potential medical writing and CRO vendors on an ongoing basis.
  • Manage the development of scientific publications: results of local studies, sub-analyses of global studies, pharmacoeconomic studies, database analysis, bibliographic reviews, and others.

About You:

  • Education: Medical, pharmacy or life-sciences degree (or equivalent).
  • At least five years' experience working in the pharmaceutical industry in a Medical/Clinical Operations role is required.
  • Good organizational and interpersonal skills, flexible, to communicate with investigators.
  • Computer and software knowledge like MS Office (Word, Excel, PowerPoint, Outlook).
  • Advanced knowledge of Clinical or Post Marketing studies and in Scientific Publishing.
  • Desirable knowledge in Clinical Operation and Clinical Research, Pharmacoeconomics, Pharmacovigilance, and Quality.
  • Experience in writing protocols.
  • Experience in publication of manuscript or abstract in scientific journals.

Compensation and Benefits:

The estimated annual salary for this position is $120,000 - $180,000 depending on experience. Abbvie offers a comprehensive benefits package including health insurance, retirement savings plan, paid time off, and professional development opportunities.

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