Local Clinical Operations Manager
hace 4 semanas
Purpose Statement:
- Collaborate with the coordination of planning, implementation, and conduction of local and global clinical studies (Post-Marketing Observational, Multi-Country Non-Interventional, Investigator Initiated, Non-AbbVie Sponsored Collaborative and Pharmacoeconomic) and Pre-Approval Access programs (PAAs) according to Abbvie business strategy across Mexico.
- Manage the activities of clinical investigation across multiple protocols of RWE and multiple therapeutic areas. Conduct these activities in accordance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, Abbvie policies and Standard Operating Procedures (SOPs) and business processes.
- Collaborate with the coordination of planning, implementation, and conduction of local publications across Mexico.
Major Responsibilities:
- Ensure the execution for Post Marketing Observational Studies (PMSO) in accordance with all relevant processes, procedures & applicable SOPs and Local regulations; making certain that data is delivered within the agreed parameters (quality/time).
- Establish evidence governance in collaboration with Market Access to develop local long-term evidence strategies implemented through tailored research plans.
- Prepares CA (Competent Authority) and/or EC (Ethic Committee) documentation, ensures submissions and/or notifications are performed as applicable. Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up.
- 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 the 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. Anticipates and identifies site issues that could affect Clinical Studies timelines and collaborate in developing alternative solutions. Collaborate with senior staff to develop initiatives and contingencies to ensure that timelines are met.
- Manage projects according to budget and report progress to budget.
- Anticipate potential problems within a study and create contingency plan accordingly.
- Review and approve monitoring visit reports and enrollment updates when required.
- Ensures the management and tracking of all regulatory documents.
- Lead the process of scientific publications in the affiliate. Initiate, monitor and manage affiliate publication activities and oversight of publication management e.g., planning (annual publication plan) including budget planning tracking of publication activities and reviewing publication plan regularly by publication lead.
- Identify, evaluate, and recommend new/potential medical writing and CRO vendors on an on-going basis.
- Manage the development of scientific publications: results of local studies, sub-analyses of global studies, pharmacoeconomic studies, database analysis, bibliographic reviews, and others.
- Ensure the operational support to the "Publication Lead" of the entire internal and external process for the execution of the publications. Ensure that all affiliate "Publication Leads" receive the required training.
- Identify and address affiliate publication projects issues, with elevation to ensure resolution if appropriate. Minimize any potential publication process deviations. Ensure that local scientific publications are developed in accordance with AbbVie policies.
- Ensure that external authors have authorship criteria to manage so that publication-related activities are carried out in compliance with AbbVie's policies.
- Ensure the dissemination of locally generated evidence.
Qualifications
- 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.
- Experience being an active contributor to cross-functional teams and/or working in matrix organizations will be an advantage.
- English language management verbally and in writing.
Additional Information
AbbVie 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.
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