Clinical Science Lead

21 hours ago

Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 1,04,000 - ₹ 1,30,878 per year

Hiring for Clinical Science Lead - Medical Monitoring for a leading Pharma client

Mumbai

  • TASKS AND RESPONSIBILITIES

  • Lead the clinical research medical science related activities such as preparation of synopsis, protocol, Clinical Study Report (CSR) and present the proposals in subjects expert committee (SEC) regulatory meeting

  • Collaborate with clinicians, KOL to get the feedback and inputs on clinical trial design, comparator and endpoints of the study to finalize synopsis.
  • Review of patient eligibility and approval of patients through Interactive Response Technology (IRT) system
  • Work with data management team to review data management plan, coding plan, SAE reconciliation, CRF completion guidelines, edit check specifications. Also, to ensure timely review of data extract and data cleaning activities to ensure timely database lock and release of tables, figures, and listings (TLFs)
    • Coordinate with biostatistician to engage early with the study team to decide sample size, statistical analysis plan (SAP) apart from review of mock and/or blinded tables, figures, and listings (TFLs), and narrative and discussion planning for relevant documents
  • Prepare risk assessment plan based on the protocol of clinical study to identify and address the safety and operation related risk specific to study protocol
  • Training the study team on protocol and applied aspect of the protocol to clarify the relevance and criticality of each activity considering the study endpoints
  • Interact with investigator to resolve the queries related with protocol from the sites and Ethics Committee
  • Medical monitoring activity which includes eligibility assessment based on inclusion, exclusion criteria and detailed medical history, review of study endpoint data review and safety investigations

  • Qualifications

  • MD (Pharmacology) or other relevant medical qualification

  • 2-6 years of relevant experience of working in clinical science domain working in different capacities as medical monitor for clinical trial/ medical expert for clinical development plan for products across therapies is desirable

to apply please share Resumes with

Regards

Puja Khemchandani

  • Clinical Data Science Lead

    6 days ago

    Mumbai, Maharashtra, India beBeeData Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Job Title: Clinical Data Science LeadJob DescriptionThis role involves leading functional activities for medium to large-sized projects in phase I to IV clinical studies. As a Clinical Data Science Lead, you will coordinate the activities of data managers, make data management decisions, and propose strategies at the study or project level.You will be...

  • Clinical Quality Assurance Compliance

    4 hours ago

    Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Job Title:Clinical Quality Assurance Compliance & trainingExperience: 5 plus yearsLocation:MumbaiType:Full-timeExperience Level:[Senior] Manager/Senior ManagerDepartment:Clinical Research DepartmentPurpose of this Role:This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable...

  • Manager Clinical Quality Compliance andTraining

    5 hours ago

    Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Position Title: Sr. Manager/ Manager Clinical Quality Compliance and TrainingYOUR TASKS AND RESPONSIBILITIES: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective.This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical...

  • Clinical Programming Lead

    3 days ago

    Mumbai, Maharashtra, India Johnson & Johnson Full time

    Clinical Programming Clinical Programming Lead SDTM Programming At the Janssen Pharmaceutical Companies of Johnson Johnson we are working to create a world without disease and the development of best-in-industry data science capabilities is critical to our ambition to be most innovative healthcare company Within Integrated Data Analytics Reporting ...

  • Clinical Study Startup and Regulatory Executive/Manager

    2 days ago

    Navi Mumbai, Maharashtra, India Expecto Health Science Full time US$ 90,000 - US$ 1,20,000 per year

    Company DescriptionExpecto Health Science is a leading Clinical Research Organization based in Singapore, specializing in Clinical Development, Data Management, Medical Writing, Regulatory, and Pharmacovigilance services in the Asia Pacific Region. The company offers tailored solutions to a diverse client base, including global Pharma clients and...

  • Leads Clinical Programming Initiatives

    3 days ago

    Mumbai, Maharashtra, India beBeeClinical Full time US$ 80,000 - US$ 1,40,000

    Job Title: Clinical Programming LeadJob DescriptionWe are seeking a highly motivated Clinical Programming Lead to contribute to the growth of our Clinical Programming team within Integrated Data Analytics, Reporting (IDAR). The team is responsible for creating SDTM submission-ready deliverables, SDTM specifications, ACRF datasets, xpt define XML, cSDRG,...

  • Lead Clinical Programmer

    7 days ago

    Mumbai, Maharashtra, India beBeeClinical Full time ₹ 80,00,000 - ₹ 1,20,00,000

    Key ResponsibilitiesGenerate and track reports for various business functions within our organization used for ongoing monitoring of clinical data.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end-users on creating specifications and working with programmers or...

  • Global Clinical Project Lead

    3 days ago

    Mumbai, Maharashtra, India beBeeClinicalProjectManager Full time US$ 1,25,000 - US$ 1,75,000

    Job DescriptionAbout the Role:We are seeking a skilled professional to oversee complex global studies, act as a trusted advisor to clients, and mentor project managers and cross-functional team members.Key Responsibilities:Lead end-to-end delivery for complex/late-phase or multi-country trials; oversee multiple concurrent Global studies or an integrated...

  • Clinical Operations Manager

    1 week ago

    Mumbai, Maharashtra, India beBeeData Full time ₹ 80,00,000 - ₹ 1,50,00,000

    Lead Data StrategistJob OverviewAs a seasoned clinical data strategist, you will oversee data management activities for our clinical trials. Your expertise in data governance, integrity, and quality will ensure seamless execution of project-level activities.ResponsibilitiesManage data load, transfer, and conformance to NCDS compliant standards.Develop and...

  • Chief Data Science Leader

    1 week ago

    Mumbai, Maharashtra, India beBeeData Full time

    Lead Clinical Data ScientistOur organization seeks an experienced and skilled professional to lead our clinical data management initiatives. The ideal candidate will have a strong background in data architecture, governance, integration, profiling, quality, science, strategy, and master data.\