Job Description Summary
Monitors patient data & study-related information related to clinical study sites and clinical trial participation. Ensures the investigator adheres to research protocols, regulatory requirements, and good clinical practices and provides input into data validation plan. Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable. May monitor study sites and audit facility selection.
Job Description
Key responsibilities:
Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial.
Applies company policies and procedures to resolve a variety of issues.
Frequent internal company and external contacts.
Represents organization on specific projects.
Is the frontline liaison between Novartis and sites to ensure successful collaboration, site engagement, and meeting Novartis expectations on milestone and deliveries.
Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.
Key performance indicators:
Deliver customer satisfaction results for internal & external customers.
Delivery of Clinical Trials to quality standards and agreed timelines.
Adherence to Novartis policy and guidelines and external regulations.
Requirements:
Degree in scientific or healthcare discipline and ideally 1-2 years pharmaceutical industry experience or other relevant experience.
Good knowledge of drug development process specifically clinical trial/research.
Clinical and therapeutic knowledge.
Central/in-house monitoring or field monitoring experience is desirable.
Knowledge of international standards (GCP/ICH, FDA, EMA).
Excellent time management and organization capabilities, including ability to prioritize and multi-task.
Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
Fluent in both written and spoken English. Excellent communicator and presenter, ability to influence others & Relationship management.
Ability to manage sites independently; Proven ability to work independently with minimal supervision.
A full UK driving license.
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
Novartis People and Culture Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook:
Novartis Benefits and Rewards Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Novartis Network Skills Desired:
Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences.
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Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
Novartis People and Culture Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook:
Novartis Benefits and Rewards Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Novartis Network Skills Desired:
Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences.
#J-18808-Ljbffr
