- Considered as the primary Sponsor point of contact for the investigative site, provides contextual
information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
• Aligns, trains and motivates the site staff and principal investigator with support as needed on the
goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership.
• Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure
activities with support as needed, in compliance to the protocol and monitoring plans and accordance
with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research, ensuring safety and protection of study subjects.
• Customize site engagement strategy for assigned study (ies) with support as needed. Gather
local/site insights and utilize site engagement tracking tools, to report/track progress and measure impact of that strategy.
• Fundamental level of competency connecting the study protocol, scientific principles and clinical
trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective
recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
- Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
• Identifies, evaluates and recommends new/potential investigators/sites with support as needed
from more experienced Site Monitors.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Ensures audit and regulatory inspection readiness at assigned clinical site at all times.
• Manages investigator payments as per executed contract obligations, as applicable.
- Appropriate tertiary qualification in health-related disciplines (e.g., Medical, Scientific, Pharmacy,
Nursing) preferred or experience or equivalent work experience.
• Clinically related experience, in clinical research coordinating or data management preferred.
• Knowledge of appropriate therapeutic area indications is preferred with the ability to understand
and apply scientific concepts as they relate to the conduct of clinical trials.
• Knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines
and applicable policies.
- Able to work collaboratively and cross functionally to develop and sustain working relationships.
• Demonstrate planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
• Ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
• Interpersonal skills with strong written, verbal, active listening and presentation skills, with ability to
establish and leverage site relationships and trusted partnerships through engagement, motivation,
and training.
• 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. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.
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.
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AbbVie's 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 people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.
Originally posted on Himalayas