Company Overview外資製薬メーカー/スペシャリティケア領域に強み Overseas based pharmaceutical firm, strong in Specialty Care
Job Description•Accountable for all activities of site related study execution of assigned studies / Monitors involving startup, execution, and closeout.
•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, 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.
Requirements•Education: 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.
•Demonstrated business ethics and integrity.
Additional Job InformationTravel: Yes, 20 % of the Time
Job Type: Experienced