Clinical Scientific Expert I

3 days ago


Hyderabad Telangana, India Novartis Full time

**Summary**:

- Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team. -Applicable to Clinical Scientific Expert IThe Clinical Scientific Expert I (CSE I) provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with Novartis processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The CSE I is a core member of the Clinical Trial Team (CTT) and may support program level activities as assigned.

**About the Role**:
**Major accountabilities**:
Your responsibilities include, but are not limited to:

- **Responsibility for ensuring high quality clinical trial data review/insights and analysis as directed by the Integrated Clinical Trial Team (iCTT)**:

- **Contributes to the development the Data Review/Quality Plan (DRP/DQP) 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, may 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.**:

- **May contribute (in collaboration with relevant line functions) to the development of study-level documents, including clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. In collaboration with relevant line functions, review/write clinical trial documents for study 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.**:

- **Produce training materials and provide training to iCTT.**

**Minimum Requirements**:

- **Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master's, PharmD, M.Pharma, PhD, MBBS, BDS, MD strongly preferable. Fluent English (oral and written).**:

- **>1 year experience in pharmaceutical industry/ clinical research organization - Basic knowledge in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization.**:

- **Work experience in clinical operations preferable. Strong interpersonal skills - Ability to work under pressure**:

- **Good negotiation and conflict resolution skills - Collaborates across boundaries for shared success - Resolve issues with mínimal supervision and understands when to escalate - Fundamental knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process - Strong analytical / computational background - Demonstrates strong Medical / scientific writing skills.**:
***
**Why Novartis**:
**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._**

**You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.**

Division

Development

Business Unit

Innovative Medicines

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

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



  • Hyderabad, Telangana, India Novartis Full time

    “150! Clinical scientific experts, globally, are part of Global Drug Development (GDD) team, working to ensure clinical trial data and regulatory reports are of highest quality throughout the life cycle of each program, across all disease areas. Be part of a dedicated, passionate team that is diligently providing clinical and scientific inputs at study and...


  • Hyderabad, Telangana, India Novartis Full time

    Summary -Oversees all operational aspects of clinical trials end-to-end including the planning execution and interpretation of clinical trials research data collection activities and clinical operations -Complete oversight of budget and resource allocation within assigned trial Drives operational excellence through process improvement and knowledge...


  • Hyderabad, India Novartis Full time

    “150! Clinical scientific experts, globally, are part of Global Drug Development (GDD) team, working to ensure clinical trial data and regulatory reports are of highest quality throughout the life cycle of each program, across all disease areas. Be part of a dedicated, passionate team that is diligently providing clinical and scientific inputs at study and...


  • Hyderabad, Telangana, India Novartis Full time

    Summary To write edit reconcile and manage high quality medical and scientific communications including manuscripts literature review abstracts posters slide sets for publication presentation or for submission to regulatory authorities and or clinical teams Senior Scientific Writer ILocation Hyderabad LI HybridMajor accountabilities Prepares...


  • Hyderabad, India Syneos Health Clinical Full time

    **Description** **SPVG Scientific Specialist I** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of. As a part of the Syneos Health...


  • Hyderabad, Telangana, India Dr. Reddy's Laboratories Full time

    To Provide medical opinion and clinical strategy for a new project to be introduced in to Emerging markets China Brazil Russia Japan with respect to preclinical clinical studies required cost timelines and market risk associated with proposed projects Preparation of clinical study synopsis for the various phases of clinical development to seek study...


  • Hyderabad, India Statistics & Data Corporation (SDC) Full time

    **Clinical Data Associate I** Statistics & Data Corporation (SDC), A global contract research organization (CRO) providing clinical trial solutions for pharmaceutical, biologic, and medical device/diagnostic companies since 2005. Our core expertise is strategic scientific consulting and clinical data services which include biostatistics, data...


  • Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Role Description:The Expert Content Manager, Scientific Communications is a key member of the Scientific Communications organization within the Global Medical Organization. The role is accountable for delivering high quality innovative scientific, publications and medical content aligned to their designated Therapeutic Area / product (General Medicine,...


  • Hyderabad, Telangana, India Novartis Full time

    **Summary**: The Associate Medical Expert in TCO (Translational Clinical Oncology), is the medical leader for assigned global, roll-over and long-term follow-up studies, and studies in the close-out phase. They may also provide medical support for assigned aspects of a global, active, TCO study, under the leadership of a Clinical Program Leader (CPL) and /...


  • Hyderabad, Telangana, India Amgen Full time ₹ 1,20,000 - ₹ 2,60,000 per year

    Career CategoryMedical AffairsJob DescriptionRole Description:The Expert Content Manager, Scientific Communications is a key member of the Scientific Communications organization within the Global Medical Organization. The role is accountable for delivering high quality innovative scientific, publications and medical content aligned to their designated...