Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.To enable AbbVie’s emergence as a world class R&D organization, the Site Management andMonitoring (SMM) Country/District COM plays a leadership role accountable for driving the businessof SMM within a Country/District(s) by providing oversight and direction to SMM staff; accountablefor the on time, within budget and quality delivery of the clinical studies. Promotes best practice;identifies infrastructural improvements and implements action plan to ensure Clinical FieldOperations (CFO) and business objectives are successfully met; ensures alignment of local activitieswith regional/global initiatives. The role reports into the Site M&M Leadership and serves as a singlepoint of accountability for the SMM deliverables within a Country/Disitrct(s) and influences andaligns within Development Operations, and with Global Medical Affairs (GMA), and other keystakeholders across the organization.Responsibilities :List up to 10 main responsibilities for the job. Include information about the accountability andscope.Manages/oversees site/country or district related activities as they relate to AbbVie clinical studies(e.g. country feasibility, site evaluation/selection and activation, contracts/budget negotiation,regulatory/EC submissions startup, issue management, relationship management, monitoring, siteclosure). Accountable for the on-time and within budget execution of all clinical trials within aCountry/District(s). Provide local regulatory and legal requirement expertise.Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices(GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and toquality standards in conducting clinical research. Monitor regulatory reforms and industry trendswithin country / region. Conduct and/or implement impact analysis of all significant changes toconform with updated regulatory / industry regulations affecting conduct of clinical studies.Ensures audit and inspection-readiness at all times. Country contact for regulatory agencyquestions related to monitoring processes and procedures. Drive CAPA preparation andimplementation.Accountable for managing country/district resources including need identification, timely hiring andallocation, and managing changes to hiring plan. Responsible for staff recruitment and retentionplans.Accountable for functional budget planning and administration.Provide leadership to the Country/District and be accountable for growth and development of aworld class workforce that role models AbbVie behaviors.Drives a learning environment and ensures continuous improvement in Country/District(s)performance by using innovative approaches, active analysis of Key Performance Indicators,metrics and milestones. Driving simplicity in process and approach, and enhancing agility.Accountable for ensuring SITE M&M leadership, collaboration and teamwork across all keystakeholders within the Country(s).May lead global Task Forces and Initiatives. Interacts with peers within the industry to stayabreast of regulatory landscape, raise AbbVie’ s profile in the R&D community. Accountable fordriving affiliate R&D Community goals in partnership with GMA.Qualifications
Qualifications :List required and preferred qualifications up to 10). Include education, skills and experience.Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing,Pharmacy) preferred.Site Monitoring Experience: Minimum 3 years. Preferably having monitored and/or managed astudy within a Country from start to close.Experience in functional budget planning, resource planning & assignment, quality management ina Country lead capacity preferred.At least 2 years of experience in line management of staff including acquisition of talent,performance management, growth and development, managing employee relations, coaching andmentoring of staff and teams preferred.Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectivesand drive smart decision making.Excellent interpersonal skills with the ability to communicate persuasively and with clarity,flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstratedproactive and positive team player.Exhibits strong planning and organizational skills and high level of flexibility in a dynamicenvironment with experience leading (within country or region) projects with competing deadlines;Experience across multiple Therapeutic Areas and Study Phases.Demonstrating business ethics and integrity.Additional InformationAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.htmlUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.html
