About the role
PRIMARY FUNCTION/OBJECTIVE
Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of 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.
CORE JOB RESPONSIBILITIES
Considered as the Primary Sponsor Point of contact for the investigative site.
Advanced level of competency or experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie positioning.
Ability to motivate and align monitoring community through leadership and mentorship.
Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership.
Able to support, guide, and mentor junior personnel on Site Management activities.
Conducts site evaluation, site training, routine on-site and off-site monitoring, 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, ensuring safety and protectionㅍof study subjects.
Superior understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.
Superior level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities.
Expert understanding to generate and ensure effective recruitment and retention techniques/plans based on the patient’s disease journey.
Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
Possesses advanced level of competency to mentor and train less experienced CRAs on various aspects of work and provides in put into their development. Supports local onboarding of more junior CRAs.
Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes.
May participate/lead in global/local task forces and initiatives.
Responsible for activities assigned by manager.
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.
Superior ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution.
Ensure preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a Cust Independently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstrating expert understanding and decision making.
Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
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.
Minimum of 3 years of clinically related experience, of which a period of 2 years is preferable in independent clinical research monitoring of investigational drug or device trials in any therapeutic area.
Familiar with risk‐based monitoring approach, onsite and offsite monitoring.
Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
Superior knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders.
Demonstrate superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
Superior ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
Superior interpersonal skills with excellent 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 independently use functional expertise, 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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About AbbVie
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 . Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.
Originally posted on Himalayas