[New Job Vacancy] Clinical Research Associate job in Novartis, (Hyderabad, Telangana) – Jobs in Hyderabad, Telangana

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Job Opening details:-
Company Name :-
Novartis
Position Name :- 
Clinical Research Associate
Company Location :-
Hyderabad, Telangana
Job Category :-
Jobs in Hyderabad

Full Job Description :-

Job detailsJob TypeFull-timeFull Job Description

~500 studies across multiple therapeutic areas. This is the exposure and scale our Data Management group has. We are on our journey to Reimagine medicine with Data and Digital and our team is focused on delivering data which is fit for purpose. Innovation at scale is one of the strategic pillars for us as a Clinical Data Management team and you will have an opportunity to apply your skills to experiment and innovate ways to transform the Clinical Data Management process in Drug Development. We are looking for individuals with end to end experience in clinical data management. You will play a key role in providing leadership to various teams and developing cross-functional data cleaning strategies.

Your responsibilities:
Your responsibilities include, but are not limited to:
Allocation, initiation and conduct of trials

Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial. Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
Manages assigned study sites and networks, if applicable, 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. Retrains site personnel as appropriate
Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety. Is accountable for continuously updating all electronic systems (global and local) relevant to perform job functions.
Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.). Performs 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
Documents monitoring activities appropriately following Novartis standards. Collaborates with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans, as needed. Participates from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines. Performs additional task as assigned
Delivery of quality data and compliance to quality standards

Monitors studies as per current legislations, ICH/GCP and Novartis standards. Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring. (ADIS, DBL). Identifies issues at sites; resolves issues and escalate as appropriate
Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry. Ensures the site Investigator Folder is up to date. Is responsible for collecting essential documents from site and accountable to keep sTMF(s) current. Supports the implementation of innovative processes and technologies
Budget and productivity

Negotiates investigator remuneration; prepares financial contracts between Novartis and investigational sites and investigators. Ensures that payments are appropriately triggered to investigational sites

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum requirements

What you’ll bring to the role:

Degree in scientific or healthcare discipline.
Up to 2 years pharmaceutical industry experience or other relevant experience
Good knowledge of drug development process specifically clinical trial/research
Knowledge of international standards (GCP/ICH, FDA, EMEA)
Monitoring experience is desirable

Important for the role:

Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
A minimum of 50% 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 innovation. That 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 flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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 hear 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

India

Work Location

Hyderabad, AP

Company/Legal Entity

Nov Hltcr Shared Services Ind

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No

Hiring InsightsJob activityPosted Today

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