Company
(Senior)ClinicalResearchAssociate
Neural analysis suggests this role is
optimal for Senior candidates.
“(Senior) Clinical Research Associate. Skills: Site relationship management, On-site and remote monitoring activities, Phase I-IV GDD trials, ICH/GCP, Compliance, Risk mitigation, Process improvements, Collaboration. Site relationship management. On-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV GDD trials”
What You'll Achieve.
Sustainable trial execution at Site; Timely completion of Phase I-IV GDD trials; Meeting Novartis expectation on milestone and deliverables; Ensure compliance with protocol, ICH/GCP, global and local regulation; Ensure human subject protection and reliability of trial results; Increase patient density; Decrease issues at site; Ensure timely and accurate data entry
Industry & Context.
Issue management; Risk identification; Risk mitigation; Problem solving
What They're Looking For.
Must Have
Degree in scientific or healthcare discipline, Fluent in both written and spoken English and country language, Minimum 3 years pharmaceutical industry experience or other relevant experience
Nice to Have
Field monitoring experience is desirable, Decision capability, Excellent time management and organization capabilities, including ability to prioritize and multi-task, Risk based mindset (from issue management to risk identification) supported by Novartis systems, Early adopter and open mindset across borders to support one study approach, Good knowledge of drug development process specifically clinical trial/research, Clinical and therapeutic knowledge, Knowledge of international standards (GCP/ICH, FDA, EMA), Understanding the purpose of the CRA (Patient Data PI GCP/ICH & Protocol Compliance)
What You'll Do.
Site relationship management
On-site and remote monitoring activities related to initiation
conduct and timely completion of Phase I-IV GDD trials
Proactive site performance management (recruitment & quality)
Early identification of real site needs and issues
Subject Matter Expert (SME) as needed
Participates in audit organization and inspection readiness activities
Ensures implementation of corrective actions
Participates in multi-disciplinary teams to evaluate and implement process improvements
Frontline liaison between Novartis and sites
Manages assigned study sites
conducting phase I-IV protocols
Performs Site Initiation Visit
Ensures site personnel is fully trained
Performs continuous training
Conducts continuous site monitoring activities (onsite and remote)
Implements site management activities to ensure compliance
Identifies deficiencies in site processes
Works in close collaboration with site on risks mitigation and process improvements
Promotes a compliance culture
Establishes a partnership and true collaboration with the site
Early engagement with site on patient inventory and patient flow
Performs Site Closeout activities
disease indication and project specific training and general CRA training
Collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as MSL
CRMA and medical advisor
Ensures that relevant site insights are shared with internal stakeholders
Collaborates with internal stakeholders and site personnel to manage data query resolution process
Ensures the site Investigator Folder is up to date
Responsible for collecting essential documents from site
Accountable to keep sTMF(s) up to date
How You'll Work.
Team & Collaboration
Frontline liaison between Novartis and sites; Works in close collaboration with site on risks mitigation and process improvements; Proactively collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as MSL, CRMA and medical advisor; Ensures relevant site insights are shared with internal stakeholders; Collaborates with internal stakeholders and site personnel to manage data query resolution process; Participates in multi-disciplinary teams locally and globally
Communication Scope
Fluent in both written and spoken English and country language
Process & Methodology
Manages assigned study sites, Site performance management, Issue management, Risk identification, Risk mitigation, Time management, Organization capabilities, Ability to prioritize, Ability to multi-task
Full Job Description
**Band** Level 3 **Job Description Summary** 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 GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and 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).Senior Clinical Research Associate (sCRA) is assigned to more complex trials and/or to less experienced sites where applicable. Associate takes on the responsibility as SME (Subject Matter Expert) as needed, 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, and participates in multi-disciplinary teams locally and globally to evaluate and implement process improvements. **Job Description** **Key Responsibilities:** * Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset * 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, IRB/EC, data privacy requirements, global and local processes as applicable. Doc
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