Senior Clinical Research Associate

🕒 il y a 26 jours

🇵🇱 Pologne – Télétravail

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 13%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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AbbVie

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 2013

🏥 Santé

💼 Conseil

🏭 Fabrication

Healthcare • Consulting • Manufacturing

AbbVie est une entreprise pharmaceutique mondiale qui découvre et fournit des médicaments et des solutions innovants pour améliorer les vies. Axée sur le traitement des défis de santé les plus difficiles au monde, AbbVie opère dans plus de 175 pays, offrant une large gamme de produits dans des domaines tels que l'immunologie, l'oncologie, les neurosciences et les soins esthétiques. Engagée dans l'innovation scientifique, AbbVie investit massivement dans la recherche et le développement, visant à produire des médicaments de premier ordre. L'entreprise met également l'accent sur la diversité au sein du lieu de travail, la durabilité et les initiatives de soutien aux patients, assurant un impact positif tant pour ses patients que pour la communauté au sens large.

Description

• Advance AbbVie's clinical research pipeline by striving for excellence in clinical research • Partner with study teams, internal R&D stakeholders, investigators and site staff • Serve as the primary Sponsor point of contact for the investigative site • Provide contextual clinical-trial information and connect stakeholders with investigative sites • Motivate and align the monitoring community through leadership and mentorship • Train and motivate site staff and principal investigators on trial goals, protocol and patient-treatment principles • Support, guide and mentor junior personnel on Site Management activities • Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring • Ensure compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, AbbVie SOPs and quality standards • Customize site-engagement strategies and track progress and impact using site-engagement tools • Apply scientific principles and clinical-trial requirements to day-to-day trial execution • Generate and ensure effective patient recruitment and retention techniques and plans • Develop therapeutic-area, asset, clinical-landscape and patient-journey knowledge • Mentor and train less experienced CRAs and support local onboarding • Participate in or lead global/local task forces and initiatives • Conduct continuous risk assessment with the Central Monitoring team to identify study-performance or patient-safety issues • Resolve site-risk signals and implement preventative and corrective action plans • Identify, evaluate and recommend investigators and sites for clinical studies • Ensure data quality and timely submission, including safety-event reporting and follow-up • Maintain audit and regulatory inspection readiness at assigned clinical sites • Manage investigator payments according to executed contract obligations, as applicable

🎯 Exigences

• Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred • Minimum of 3 years of clinically related experience • Preferably 2 years in independent clinical research monitoring of investigational drug or device trials • Familiarity with risk-based monitoring approach, onsite and offsite monitoring • Knowledge of appropriate therapeutic area indications and scientific concepts related to clinical trials • Superior knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies • Advanced communication and cross-functional collaboration skills • Superior planning and organizational skills; ability to work effectively in a dynamic environment with competing projects and deadlines • Ability to leverage technology, tools and resources for customer-centric site support • Superior interpersonal, written, verbal, active listening and presentation skills • Ability to independently use functional expertise, critical thinking and good judgement to address clinical site issues • Integrity in accordance with AbbVie code of business conduct and leadership values • Self-motivated and focused on timely, quality outcomes • Excellent command of English and local language

🏖️ Avantages

• Employees can work remotely • Equal opportunity employer • Commitment to operating with integrity, driving innovation, transforming lives and serving the community