Clinical Scientific Expert I

6 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

    **Summary**: “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...

  • Scientific Writer I

    4 months ago


    Hyderabad, Telangana, India Bristol-Myers Squibb Full time

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Hyderabad District, Telangana, India Novartis Full time

    7000 patients, 1200 clinical sites, 40 countries, 100+ clinical studies led by Novartis Clinical Sciences & Innovation (CS&I) last year. Who are we? We are Clinical Sciences and Innovation at Novartis. A dynamic group of Clinical Scientists who plan and execute early phase trials worldwide in general medicine. From First-in-Human to Proof-of-Concept and...


  • Hyderabad, Telangana, India Novartis Full time

    392687BR **Expert Regulatory Writer**: India **About the role** Position Title: Expert Regulatory Writer About the role: Expert Regulatory Writer Location - Hyderabad #LI Hybrid The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will develop documents which cover all Novartis therapeutic areas and therapies,...


  • Hyderabad, Telangana, India Novartis Full time

    **Summary**: Working in partnership with the Client Engagement team, Medical Communications, and the Writing delivery team for a designated client group/therapeutic area (TA)/brand, this role will be responsible for delivering and supporting scientific excellence of Medical Communications services across their accounts **About the Role**: Principal...

  • Scientific Writer I

    3 months ago


    Hyderabad, India Bristol Myers Squibb Full time

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Hyderabad, India Novartis Full time

    387199BR **Associate Medical Expert**: India **About the role** Associate Medical Expert Location - Hyderabad #LI Hybrid About the Role: The Associate Medical Expert will ensure the successful implementation and delivery of the Medical and Knowledge Solutions (MKS) scientific and medical services along the business colleagues’ requirements. He/ she is...


  • Hyderabad, India Bristol Myers Squibb Full time

    Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Scientific Writer Ii

    3 months ago


    Hyderabad, Telangana, India Novartis Full time

    **Summary**: To write and/or edit under guidance high quality clinical and safety documents: non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registration Documents or Patient Narratives **About the Role**: - Scientific Writer II - Location - Hyderabad #LI Hybrid - About the Role: - To write and/or...


  • Hyderabad, Telangana, India Bristol-Myers Squibb Full time

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Principal Scientist I

    1 month ago


    Hyderabad, Telangana, India Novartis Full time

    **Summary**: - Designs and conducts absorption, distribution, metabolism and excretion (ADME) research on compounds, drug agents and metabolites in pre-clinical and/ or clinical development. Using a physicochemical approach, attempts to compile various data such as absorption and excretion rates and drug agent halflife in order to establish pharmacokinetic...

  • Scientific Writer Ii

    4 months ago


    Hyderabad, Telangana, India Bristol-Myers Squibb Full time

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • hyderabad, India Seven Consultancy Full time

    JOB DETAILS 1 Develop and maintain in-depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance/ participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self-study of the national/international literature.2 Provide expert medical/scientific advice for assigned...

  • I&am Security Expert

    1 month ago


    Hyderabad, Telangana, India DSM Full time

    Job title - I&AM Security Expert Location - Hyderabad Job model - Hybrid The I&AM Security Expert will be responsible for contributing towards I&AM solution designing, implementations and management that we deliver to dsm - firmenich business. A Security Expert for Identity and Access Management (I&AM) will collaborate with various stakeholders to...

  • Clinic Assistant

    3 weeks ago


    Hyderabad, Telangana, India SRI DENTAL CLINIC Full time

    I am looking for a dental clinic assistant who knows minimum English. Telugu compulsory. Preferably who stays near karkhana and west maredpally.Clinic timings Monday to Saturday morning 9.30am to 1pm and evening 5 p.m. to 8 30pm. Sunday holiday. Pay: ₹100,000.00 - ₹120,000.00 per year Work Location: In person

  • Safety Reporting Admin

    3 months ago


    Hyderabad District, Telangana, India Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Tco Physician

    4 months ago


    Hyderabad, Telangana, India Novartis Full time

    **Summary**: Medical expert for TCO (Translational Clinical Oncology) trials. Provides global medical leadership for TCO wind down studies and global co-leadership for active TCO studies when appropriate. **About the Role**: **Major accountabilities**: - Provides scientific and medical expertise on assigned clinical projects - Contributes to clinical...

  • Scientific Writer

    5 months ago


    Hyderabad, India Aganitha AI Full time

    **Join us and contribute to the discovery of medicines that will impact lives!**: **Hyderabad, India**: **About Aganitha**: **Accelerate drug discovery and development for Biopharma and Biotech R&D with **_in silico_** solutions leveraging Computational Biology & Chemistry, High throughput Sciences, AI, ML, HPC, Cloud, Data, and DevOps.** - In silico_...


  • Hyderabad, India Makrocare Full time

    Company Description **MakroCare |** **_A MakroGroup Company_**MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research,...


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

    **Principal Clinical Programmer (RAVE EDC)** Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with...