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  • Experience candidates require in Quality Control (Formulation)at Torrent Pharma

    Having sound knowledge of Operation. Troubleshooting of QC Instruments & Investigation of OOS /OOT/Deviation. e.g HPLC, UV, FTIR, Polarimeter, UV-Spectrophotometer etc. Having Knowledge of Analytical Method Validation, Verification & Method Transfer. Having skill for data interpretation, troubleshooting.
  • Hiring for regulatory affairs (US market) at Centaur Pharma - Experienced candidates only
    Hiring for regulatory affairs US market; Expertise in authoring CMC documentation for ANDA filings and post-approval submissions with hands-on experience on using eCTD software. Review the documents against the FDA guidance assuring regulatory compliance
  • Work as Senior Pharmacovigilance Reporting Associate at ICON plc

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success.

  • Novotech Hiring Clinical Research Associate

    Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System.

  • ICON plc looking for TMF Specialist

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success.

  • Job for M.Pharm, B.Pharm, MSc in Quality Assurance Department at Unison Pharmaceuticals

    Unison Pharmaceuticals Private Limited was established in 1981 with a vision of providing quality & most affordable medicines across the nation. With more than 3 decades of medical service to the society, Unison is today one of the fastest growing company in Gujarat State. The base of operation being a single state, the company has very strong footing in the market. The company strictly believes in ethics and moral values throughout the operations of the business.

    Quality Assurance Department

  • Vacancy for M.Pharm, B.Pharm in Production Department at Leben Life Sciences

    Leben Life Sciences Pvt. Ltd. (LLS) is an established pharmaceutical formulation company for more than four decades. LLS has following openings for its EU-GMP Approved Global Standard OSD & Semi-solids Formulation manufacturing facility at Akola (M.S.)

    Production Department

    Officer / Sr. Officer
    Experience : 2 to 5 yrs 
    Section : Semi-Solids mfg. (Cream,Ointment & Gel)

  • Require Senior Research Scientist at Reliance Life Sciences

    Reliance Life Sciences is a medical biotechnology-led company engaged in research and development, manufacturing and marketing of differentiated medical products and services, used to treat patients primarily in intensive and critical care units in hospitals. Three core businesses of RLS are plasma proteins, biosimilars, and later generation oncology pharmaceuticals. In addition, it has initiatives in clinical research, molecular medicine, regenerative medicine, genetherapy, peptides and oligonucleotides.

  • More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, neuroscience and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.

    Post : Senior Clinical Research Associate

    Job Description
    Objectives
    Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and Takeda requirements 

    Accountabilities :  
    • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with study protocol and applicable regulatory requirements
    • Work with CROs to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
    • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
    • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
    • Ensure site documents are available for filing in the Trial Master File (TMF) and verify that documents are maintained in accordance with GCP and local regulatory requirements
    • Ensure 100% adherence to monitoring and study plan
    • Support clinical quality in managing CAPAs and other study audit observations
    • Support Clinical Operations Lead/ Clinical Operations Manager in performing CRO oversight as per agreed parameters
    • Ensures adherence to study budget through constant monitoring for allocated study(ies)
    • Ensures dissemination of study updates to relevant stakeholders as per agreed timelines

    Candidate Profile
    • Master’s or Ph. D degree in scientific discipline or healthcare with >5 years’ experience in clinical trials industry as Clinical Research Associate
    • Good working knowledge of GCP and local clinical trial rules and regulations
    • Organizational and problem-solving skills
    • Superior communication, strategic, interpersonal, and negotiating skill
    • Proven/ stable performance records over past 2-3 years

    Additional Information
    Experience : >5 years
    Qualification : Master’s or Ph. D degree in scientific discipline or healthcare
    Location : Mumbai, Maharashtra
    Industry Type : Pharma/ Healthcare/ Clinical research
    Functional Area : Research & Development
    End Date : 20th May 2024

    Apply Online

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  • Work as Senior Clinical Scientist at Bristol Myers Squibb

    Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions.

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