About The Role
This is a site relationship management role to ensure sustainable trial execution at Site. Performs on-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV Global Drug Development (GDD) trials within the country in adherence with monitoring procedures and processes in accordance with International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) / Good Clinical Practice (GCP), local regulations and Standard Operating Procedures (SOPs). Proactive site performance management (recruitment & quality) and early identification of real site needs and issues as the single best point of contact (internally & externally) for all sites. (From issue management to risk identification).
Key Responsibilities
Your responsibilities include, but are not limited to:
- Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on achievement and deliverables with true ownership attitude.
- Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
- Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate
- Conducts continuous site monitoring activities (onsite and remote). Implements’ site management activities to ensure compliance with protocol ICH / GCP, global and local regulation including Health Authorities, Institutional Review Board (IRB) / Ethics Committee (EC), data privacy requirements, global and local processes as applicable. Documentation according to Good Development Practice (GDP) and Novartis standards.
- Promotes a compliance culture advocating adherence to the highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times.
- Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow-up activity and archiving requirements.
- Proactively collaborates with the Site & Study Operations (SSO) Clinical Project Managers (CPM) and CRA Managers as well as Medical Science Liaisons, Clinical Research Medical Advisors (CRMA) and medical advisors to ensure optimal recruitment, site development and data quality.
- Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
Minimum Requirements:
- Degree in scientific or healthcare discipline
- 2 years pharmaceutical industry experience or other relevant experience
- Central/in-house monitoring or field monitoring experience
- Knowledge of international standards (GCP/ICH, Food & Drug Administration (FDA), European Medicines Agency (EMA)
- Understanding the purpose of the CRA (Patient Safety; Data Integrity; Principal Investigator (PI) Oversight; GCP/ICH & Protocol Compliance)