Clinical Scientific Expert I

Job description

Job Description

Title: Clinical Scientific Expert I, Novartis, Dublin, Ireland

Job Summary:

Do you want to work for a Global Pharmaceutical company where you will get recognized for your hard work and commitment? Look no further, apply today. Clinical Scientific Expert, Novartis, Dublin.

Job purpose:

The Clinical Scientific Expert I is responsible for ensuring high quality clinical trial data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle in compliance with Novartis processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence with a focus on patient safety and data integrity. The CSE I is a core member of the Clinical Trial Team (CTT) and may support program level activities as assigned.

Key Responsibilities:

•Responsibility for ensuring high quality clinical trial data review as directed by the Clinical Trial Team (CTT)
•You will perform high quality clinical data review supporting Interim Analysis and Database Lock activities and facilitate resolution of clinical data issues. Collaborate with relevant line functions to advance quality data review with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review
•You may contribute to the development of the Data Review Plan (DRP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study.
•In conjunction with the relevant line functions, contribute to Case Report Form (CRF) development, and support the implementation of data capture tools.
•Contribute to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools.
•Collaborate with relevant line functions on the development of study-level documents, including clinical sections of key regulatory documents. In collaboration with relevant line functions, review/write clinical trial documents for study Clinical Trial Authorization (CTA), CSR activities, and publications.
•May support pharmacovigilance activities (e.g., reviewing/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required.
•Support/present at study level meetings (Investigator Meetings, Data Monitoring Committee (DMC) meetings or others), as required.

Other responsibilities include:
•Develop subject matter expertise (disease area knowledge, clinical data review tools and/or processes)
•Contribute to Clinical Development (CD) line function initiatives, local and/or global education and process development projects, as required.

About the Novartis Global Service Centre in Dublin:

The Novartis Global Service Center (NGSC), Dublin, was set up in 2013 and is located in a state-of-the-art facility on the Merrion Road in Ballsbridge. The center, one of five around the world, delivers a broad variety of services to the Novartis divisions and organizations worldwide. Services offered by the Dublin team include scientific and commercial services, IT, HR Operations and Procurement. There are currently several hundred associates employed at the site with 32 nationalities speaking 28 languages.

The operation is continuing to grow rapidly and has a number of exciting vacancies for experienced high-caliber candidates who are interested in working as part of an international team delivering services globally. Novartis offers a rewarding career and a comprehensive benefits package.

Novartis is a world-leading healthcare company that provides innovative solutions to address the evolving needs of patients and societies. Headquartered in Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. Novartis Group companies employ approximately 120,000 full-time-equivalent associates and its products are available in more than 180 countries around the world.

Benefits of Working for Novartis:

Competitive salary; Annual bonus
Pension scheme; Share scheme
Health insurance; 25 days annual leave
Flexible working arrangements
Subsidized dining facilities
Employee recognition scheme

‘I came for the job, I stay for the culture’

Desired profile

Minimum requirements

Requirements:

•Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, PhD or MD preferable. Fluent English (oral and written)
•1-2 years scientific, strategic and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia, or 3-4 years in Clinical Operations/Clinical Scientific role
•Intermediate knowledge of planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization or similar experience with an academic research institution
•Strong scientific knowledge in at least one therapeutic area, (e.g., understanding of basic mechanisms of diseases and associated symptoms, standard of care/treatment, scientific endpoints & clinical outcomes)
•Knowledge of principles of clinical data collection and reporting; ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting
•Analytical / computational background; ability to detect data trends and escalate as appropriate.

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons