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A leading company in the pharmaceutical industry is seeking a Clinical Study Leader in Madrid. This role involves managing clinical studies, ensuring compliance with quality standards, and leading cross-functional teams. The ideal candidate will have a Bachelor's degree, at least 6 years of clinical research experience, and a proactive approach to problem-solving.
Defines and drives the operational strategies and deliverables for one or more clinical studies. Responsible for executing clinical studies in compliance with quality standards (ICH / GCP, Global Regulations, and AbbVie policies and procedures). Proactively manages budget, timelines, and study issues; brings scientific acumen, technical expertise, and a global mindset to drive achievement of study objectives. Leader of the cross-functional Clinical Study Team.
Leads clinical operations planning through to execution in a cross-functional matrix environment and influences stakeholders to achieve milestones. Effectively manages vendors and external stakeholders, including site staff, Key Opinion Leaders, and patient groups. Demonstrates a growth mindset by continuously learning, growing, and adapting; values feedback; sees challenges as opportunities.
Coaches and supports team members, delegates tasks appropriately, and contributes to the Development Operations community. Aims to improve operational efficiencies and brings innovative ideas to teams and studies. Exhibits excellent communication and problem-solving skills. Focuses on patients and customers, navigates ambiguity, and thrives even with limited information.
On a given study, responsible for (but not limited to): development of study design, systems, tools, and documents; study budget creation and oversight; vendor selection; scope development; management of external vendors; proactive risk identification and escalation; and operational decision-making.
Creates an inclusive and innovative environment to ensure staff and studies succeed.
Provides leadership to Study Management Associates, supporting activities to meet study milestones.
Qualifications:
Key Stakeholders:
Clinical Study Team members including TA MD/SD, DSS Lead, Data Management Lead, GSML, Start-Up Lead, and Program Leads.
Additional Information:
AbbVie's commitment to diversity and inclusion, equal opportunity employment, and non-discrimination policies are emphasized. For US & Puerto Rico applicants, information on accommodations is available.
Work: Employment Type: Full-time
Key Skills: Hospital Experience, Acute Care, Basic Life Support, ICU Experience, Infusion Experience, Triage, Conflict Management, Nursing, Critical Care Experience, Epic, Medication Administration
Experience: 6+ years
Vacancy: 1