Job details
Job type full-time
Full job description
400+The number of dedicated and inspired professionals in the us tmo function who are empowered to ask new questions and make bold decisions to bring lifesaving medicines and treatments to patientsCome join our curious and unbossed team and make an impact on patient’s lives every day!
-
** this role will consider experienced candidates who live in minnesota (mn)There is no relocation for this position-
The senior cra performs monitoring activities related to initiation, conduct (recruitment, quality data collection), and timely completion of phase i-iv oncology and pharma clinical trials within the countryYou will deliver data within timelines, and required quality standards, and for adherence to monitoring procedures aligned with gcp, ich, local regulations, and sops.
Trial monitoring strategy:
Conduct feasibility and screen investigators and networks to evaluate proficiency to conduct clinical trials
Allocation, initiation, and conduct of trials:
Conduct site selection and evaluate competenciesRecommend sites to participate in clinical trialAct as liaison to sites to ensure successful collaboration, meeting novartis expectation on landmarks, and deliveries; collaborate with the cra group head/csm to ensure recruitment plans and execute contingency plans
Manage assigned sites and networks, if applicable, conduct phase i-iv protocols.
Facilitate the preparation and collection of site and country level documents
Perform site initiation visit (sivs), ensure site staff are trained on trial related aspectsPerform continuous re/training for amendments and new site staffConduct continuous monitoring activities (onsite and remote)Implement site management activities in compliance to secure data integrity and patient safety
Continuously update electronic systems (global and local) relevant to perform job functions
Ensure study targets for sites are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)Perform site closeout activities and ensure site awareness of follow-up activities and archiving requirements
Attend onboarding, disease indication and project specific training and general cra training
Participate from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions
Deliver quality data and compliance to quality standards:
Monitor studies as per current legislations, ich/gcp and novartis standardsEnsure timely delivery, of high quality, robust, and reliable data of the monitored sites to support the goals of trial monitoring
Collaborate with internal partners and site personnel to manage data query resolution process to ensure timely and accurate data entry
Ensure the site investigator folder is up to dateCollect crucial site documents and manage keeping the stmf(s) current.
Participate in multi-disciplinary teams within cpo and globally to evaluate and implement process improvement; support the implementation of innovative processes and technologies
Budget and productivity:
Negotiate investigator remuneration; prepare financial contracts between novartis and investigational sites and investigatorsEnsure payments triggered to investigational sites
Https://www.youtube.com/watch?v=husa096nn_e
Eeo statement
The novartis group of companies are equal opportunity employers and take pride in maintaining a diverse environmentWe do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected statusWe are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Minimum requirements
This position will be based remotely in mn.
Please note that this role would not provide relocation as a resultThe expectations of working hours and travel (domestic and/or international) will be defined by the hiring managerThis position will require ~25% travel **
What you`ll bring to the role:
Education -
Bachelor`s degree is required
Subject area in a life science or healthcare is preferred
Experience -
3+ years of direct experience in site monitoring, per aboveExcellent knowledge of the drug development process specifically clinical trial/research
Knowledge of international standards (gcp/ich, fda, emea)
Experienced in managing multiple priorities and managing time efficiently; basic project management skills to support in csm activities
Skills -
Adept in business communication skills and ability to influence
Critical thinking: anticipate potential issues and take actions; ability to manage sites independently; proven track record to work independently with or without minimal supervision
Advanced data accuracy expertise
Works in a focused manner with a great attention to detail.
Travel -
Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
Minimum of 25% overnight travel may be required.
-
Why novartis?
769 million lives were touched by novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovationThat a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibilityAnd we can reinvent what`s possible, when we collaborate with courage to tackle the world’s toughest medical challenges aggressively and ambitiouslyBecause the greatest risk in life, is the risk of never trying!
Imagine what you could do here at novartis!
-
Commitment to diversity & inclusion:
Novartis embraces diversity, equal opportunity and inclusionWe are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusion workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
-
Join our novartis network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about novartis and our career opportunities, join the novartis network here: https://talentnetwork.novartis.com/network
Division
Global drug development
Business unit
Gdo gdd
Country
Usa
Work location
Minneapolis, mn
Company/legal entity
Novartis pharmaceuticals
Functional area
Research & development
Job type
Full time
Employment type
Regular
Shift work
No
Early talent
No
