Key Responsibilities: 

ㆍFrontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on achievement and results with true ownership attitude. Handles assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures. 

ㆍPerforms 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

ㆍConducts 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. Documentation according to GDP and Novartis standards.

ㆍIdentifies deficiencies in site processes and supervise site processes performed outside the site, works in close collaboration with site on risks mitigation and process improvements

ㆍPromotes a compliance culture advocating adherence to the highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times 

ㆍEstablish a positive relationship and true collaboration with the site, to increase patient density and decrease issues at site. Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study team

ㆍPerforms Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow-up activity and archiving requirements. Attends onboarding-, disease indication and project specific training and general CRA training as required

ㆍProactively collaborates with the relevant teams to ensure efficient recruitment, site development and data quality.

ㆍEnsures that relevant site insights are shared with internal partners such as site partnership manager, medical advisor, MSL and CRMA etc. to improve one Novartis approach to sites. 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.

ㆍCollaborates with internal partners and site personnel to handle data query resolution process and to ensure timely and accurate data entry. Responsible for collecting crucial documents from site and accountable to keep sTMF(s) up to date.

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. 

Essential Requirements: 

ㆍ2-3 years` experience in global SIT experience as a CRA and for Senior CRA position,at least 4 years of Global SIT experience. Degree or equivalent experience in scientific or healthcare subject area  

ㆍProficient in both written and spoken English and country language. Decision capability 

ㆍExcellent time management and organization capabilities, including ability to prioritize and multi-task. Knowledge of international standard and understanding the purpose of the CRA

ㆍGood knowledge of drug development process specifically in clinical trial or search, clinical and therapeutic knowledge

ㆍAbility to travel domestically (and possibly internationally) as needed to study sites and for training and meetings. 

ㆍGood communications skills, relationship management, ability to handles site independently, good analytical thinking and ability to anticipate potential issues and take appropriate action.

 ㆍDigital and tech capabilities.

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: https://www.novartis.com/about/strategy/people-and-culture 

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-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: https://talentnetwork.novartis.com/network