To enable AbbVie’ s emergence as a world class R&D organization, the position is accountable for all activities of site related study execution directly or by leadership of assigned CRAs involving startup, execution, and closeout.
Key Responsibilities Include:
Accountable for all activities of site related study execution of assigned studies/Monitors involving startup,execution, and closeout;
Accountable for the ontime and within budget study execution of assigned projects, including but not limiting to country and site feasibility;
Oversee site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, and site closure. 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 to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies. May monitor regulatory reforms and industry trends within country/district, and provide impact analysis of significant changes affecting conduct of Clinical studies;
Ensure audit and inspection readiness of assigned sites. Advise on preaudit activities for GCP requirements;
Prepare and follow up site and system audits, CAPA preparation and implementation;
Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provide solutions;
Responsible for the acquisition and retention, performance management, and growth and development of talent;
May be responsible for being the country point of contact for CROs for an assigned study/studies. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager;
If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally. Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner;
If assigned; Independently serve as key point of contact in country/district for one or more studies with higher level complexity. Update Impact/Tesla with country level information: Country level planning timelines, LSR assignments, etc.;
If assigned; Global Representative for single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials;
If assigned; Accountable for resource management and deliverables of the assigned Remote Data Review (RDR) team. Collaborate with key stakeholders to ensure appropriate study specific training and assignment of assigned staff to studies. Responsible for the direct/functional management, as applicable, of the assigned Remote Monitors including hiring, onboarding, training, task assignment, mentorship, performance management, and growth and development.
Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
Site Monitoring Experience:
Minimum 3 years.
Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and 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. Demonstrated proactive and positive team player;
Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment, with experience leading(within country) projects with competing deadlines; Experience across multiple Therapeutic Areas and Study Phases;
Drives continuous improvement and simplicity in process and approach and enhances agility;