AbbVies 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 peoples 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.

Job Description

We remain flexible regarding the candidate’s location within Poland and are open to various places of residence.

Advance AbbVies pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance. Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

Responsibilities

• Primary point of contact for the investigative site, providing contextual information on the clinical trials and strengthening AbbVie’s positioning.
• Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles, ensuring a trusted partnership.
• Conducts site evaluation, site training, routine and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards.
• Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study(s), gathering local/site insights and utilizing site engagement tools such as the Customer Relationship Management (CRM) tool.
• Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day‑to‑day clinical trial execution activities, evaluating and ensuring effective recruitment and retention techniques/plans.
• Possesses experienced level of competency to mentor and train less experienced CRAs and may participate in global/local task forces and initiatives.
• Responsible for continuous risk‑assessment proactively in collaboration with Central Monitoring team to detect early overall study performance or patient safety issues.
• Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution.
• Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis.
• Ensures quality of data submitted from study sites, audit and regulatory inspection readiness, and manages investigator payments as applicable.

Qualifications

• Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.
• Minimum of 1 year of clinically related experience, of which 6 months in clinical research monitoring of investigational drug or device trials.
• Knowledge of appropriate therapeutic area indications and ability to understand and apply scientific concepts in clinical trials.
• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
• Strong cross‑functional collaboration skills among internal and external stakeholders.
• Strong planning and organizational skills with the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
• Strong interpersonal skills with excellent written, verbal, active listening and presentation skills.
• Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values.

AbbVie 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.