Medical Data Reviewer

1 week ago

Hubli, India Caidya Full time

Job Title: Medical Data Reviewer

Job Location: India (Remote)

Job Overview:

The Medical Data Reviewer is responsible to perform Medical data review, focused on relevant safety and efficacy parameters, as defined in the Medical Data Review Plan (MDRP) developed for each project in which these services are performed by Caidya. If the scope of data review is limited (e.g., coding review), the Medical tasks may be included only within the Medical Monitoring Plan (MMP) or equivalent document. The Medical Data Reviewer may also perform other associated tasks, as indicated, such as query formulation and review for closure, documentation of reviews, and/or completion of summary reports.

Job Duties and Responsibilities:

Job duties differ from project to project and are described in the contract, project-specific Plans (e.g. MMP; MDRP), and/or other documents agreed with Sponsor/Client. Job duties also comprise any other tasks as defined by applicable Policies/SOPs/Work Procedures (WPs) and in general include but are not limited to the following:

  • Performance of medical data review tasks to ensure applicable SOPs/Guidelines, Sponsor/Client directives, and GCP guidelines are followed;
  • Review and input into the design of eCRF fields relevant to Medical data review for the project(s);
  • Development, input, and/or review of the project-specific Medical Data Review Plans (MDRPs) or equivalent document;
  • Implementation of Medical data review tools, including but not limited to listings, patient profiles, and visual analytic templates;
  • Review and/or input into the review of the following types of Medical data:
  • Vital signs;
  • Physical examination results;
  • Laboratory tests;
  • ECG results;
  • Imaging results;
  • Adverse events, serious adverse events, and or Dose Limiting Toxicities (DLTs);
  • Concomitant medications;
  • Past medical history;
  • Protocol deviations requiring Medical review;
  • Efficacy assessments;
  • Other types of Medical data, as specified per project
  • Generation, review and/or input into the review/closure of Medical queries;
  • Preparation of project-specific reports;
  • Training of new team members in Medical data review processes, goals, and tools, as requested;
  • Attendance at internal and external (include Sponsor/Client and/or non-Caidya personnel) project specific meetings, if requested;
  • Attendance at data review meetings (interim analysis and final data analysis), if requested;
  • Review of Medical Coding to assure medical reasonability of the codes and re-coding items if it is appropriate;
  • Documentation of significant communication (interactions with sites, Sponsor/Client, internal team members and external parties etc.) as required;
  • Other tasks and responsibilities as assigned.

Additional Tasks and Responsibilities (as needed)

  • Work with staff and project teams on integrated data review, as opportunities arise, providing expertise on medical data;
  • Work closely with other functional groups and departments including but not limited to Safety/Pharmacovigilance, Project Management, Clinical Operations, Data Management, Biostatistics and QA to ensure that medical data review functions are executed effectively as per contract;
  • Take part in meetings with existing and potential clients, if requested.

Supervisory Responsibilities:

No supervisory responsibilities.

Job Requirements:

  • Education
  • Physician Assistant, MBBS/MD, Nurse Practitioner (or country-specific equivalent) required
  • Experience
  • At least 1 year of clinical experience post-degree and at least 2 years of experience in the Pharmaceutical, Biotech, Medical Device and/or CRO industry working with clinical data.
  • Highly desirable:
  • Experience of working in a Medical or drug development environment performing medical data review using visual analytics programs (e.g., Spotfire, J-Review, Tableau, Qlik Sense, Power BI).
  • Experience implementing Medical data review templates for complex data sets.
  • Experience in oncology studies.
  • Skills/Competencies
  • Clinical thinking: ability to use data review tools, to perform designated review of safety and efficacy data, and to formulate good queries; ability to understand data collection in project specific documents to optimize oversight of patient safety, data integrity and successful completion of project;
  • Deep understanding of the scientific basis for therapies and pathology induced by disease states;
  • Deep understanding of clinical databases and visual analytic templates;
  • Strong knowledge of the drug/device/vaccine development process;
  • Understanding of ICH GCP, applicable regulatory requirements for study data, good documentation practices;
  • Time management: good sense of urgency, prioritization skills;
  • Team player: effective participant as a team member and team leader;
  • Attention to detail;
  • Creative problem-solving skills;
  • Effective oral and written communication and presentation skills (at least in English) are compulsory; ability to clearly and efficiently communicate with site and team members both inside and outside to company; development and delivery of the trainings and presentations;
  • Integrity: Understanding and acting on principles of honesty, trust and fairness.
  • Capabilities
  • Proficient in the use of computers and EDC programs.
  • Ability to drive an automobile and have a valid driver’s license.
  • Must have a credit card that can be used for travel expenses.
  • Ability to work remotely.

  • Salesforce Engineer

    4 weeks ago

    Hubli, India Olympus Medical Systems India Pvt Ltd Full time

    About OlympusOlympus Medical Systems India Private Limited commenced its business operation in Indian market on April 1, 2010. Olympus Medical Systems India is a wholly owned subsidiary of Olympus Corporation, Japan. Taking a plunge into the Indian market, team at Olympus wants to be the most respected reliable and chosen brand in health care domain. Olympus...

  • Senior Product Manager

    3 weeks ago

    Hubli, Karnataka, India RediMinds, Inc Full time

    About UsAt RediMinds, we're harnessing the power of AI to transform industries. We're seeking a seasoned Senior Product Manager to lead our Medical Billing AI platform. This cutting-edge solution is revolutionizing healthcare dispute resolution by leveraging AI and automation to improve efficiency and outcomes for healthcare providers, payers, and...

  • Senior Data Protection

    1 week ago

    Hubli, Karnataka, India Poovayya & Co. Full time

    Practice Area: Technology Law, Data Protection and PrivacyJob Summary:Poovayya & Co. is seeking a talented Legal Associate to join our Data Protection & Privacy/AI Practice. As a key member of our team, you will provide strategic advice on data protection, privacy laws, and compliance obligations to clients across various industries.Key...

  • Data Science Team Lead

    2 weeks ago

    Hubli, India SPECTRUM AV TECHNO CONSULTANTS Full time

    Lead the Charge in Data Science and Machine LearningSpectrum AV Technology Consultants is seeking an exceptional Data Science Team Lead to spearhead our machine learning and analytics initiatives. As a seasoned leader, you will be responsible for overseeing a talented team of data scientists and analysts, guiding them in the development of cutting-edge...

  • Senior Data Science Team Manager

    2 weeks ago

    Hubli, Karnataka, India SPECTRUM AV TECHNO CONSULTANTS Full time

    About the RoleSpectrum AV Technology Consultants is seeking a highly skilled and experienced Senior Data Science Team Manager to lead our team of data scientists and analysts in developing cutting-edge machine learning solutions. As a key member of our team, you will be responsible for guiding the development of advanced analytics and machine learning...

  • Senior Data Science Team Manager

    2 weeks ago

    Hubli, Karnataka, India SPECTRUM AV TECHNO CONSULTANTS Full time

    Job OverviewSpectrum AV Technology Consultants is seeking a highly skilled and experienced Senior Data Science Team Manager to lead our innovative data science team. As a key member of our organization, you will be responsible for overseeing the development of cutting-edge solutions that leverage advanced analytics and machine learning techniques.Key...

  • Engineering Manager

    1 month ago

    Hubli, India Real Time Data Services Full time

    Key Responsibilities:Team Leadership:Lead, mentor, and grow a team of software engineers.Provide regular feedback, performance reviews, and career development support.Project Management:Oversee the end-to-end execution of engineering projects.Collaborate with stakeholders to understand requirements, set priorities, and allocate resources.Ensure timely...

  • Neurosurgeon

    5 months ago

    Hubli, India medirecruiters Full time

    **Job Description: Neurosurgeon (Minimum 2 years of experience)** We are seeking a highly skilled and experienced Neurosurgeon to join our medical team. As a Neurosurgeon, you will play a vital role in providing exceptional patient care, diagnosing and treating disorders and injuries of the brain, spine, and nervous system. With a minimum of 2 years of...

  • Senior Data Science Team Manager

    2 weeks ago

    Hubli, India SPECTRUM AV TECHNO CONSULTANTS Full time

    Key Responsibilities:We are seeking a highly skilled and experienced Technical Lead to join our innovative team at SPECTRUM AV TECHNO CONSULTANTS. As a key member of our data science team, you will be responsible for overseeing the development of cutting-edge analytics and machine learning solutions.About the Role:As a Technical Lead, you will play a pivotal...

  • Orthopedic Surgeon

    5 months ago

    Hubli, India Chaitanya HR Consultancy Full time

    ***: - Consulting with patients and analyzing patient data to determine patient needs and treatment goals. - Examining patients to diagnose bone, joint, ligament, or other musculoskeletal problems, including diseases, or injuries. - Collaborating with other specialists, when necessary, to determine a course of treatment. - Recording patient care by...

  • Agm - Area Sales

    5 months ago

    Hubli, India Vodafone Idea Full time

    Job Req ID: 42448- Location: Hubli, IN- Function: Sales and Distribution- About: - Vodafone Idea Limited is an Aditya Birla Group and Vodafone Group partnership. It is India’s leading telecom service provider. The Company provides pan India Voice and Data services across 2G, 3G and 4G platform. With the large spectrum portfolio to support the growing...

  • Agm- Area Sales

    5 months ago

    Hubli, India Vodafone Idea Full time

    Job Req ID: 44044- Location: Hubli, IN- Function: Sales and Distribution- About: - Vodafone Idea Limited is an Aditya Birla Group and Vodafone Group partnership. It is India’s leading telecom service provider. The Company provides pan India Voice and Data services across 2G, 3G and 4G platform. With the large spectrum portfolio to support the growing...

  • SESSE-Hubli Channel Project

    3 weeks ago

    Hubli, India 2coms Full time

    Position : Senior Sales Executive Line of Business : Natural Veneers Location : Hubli Role : ChannelProject Sales Job Responsibility : Meet Sales Target Project Scouting & Architect/ Builder/ Contractor handling Handling Dealer/ Distributor/ Channel Partners Lead Generation Demand Generation Compensation : Hike as per Industry Norms JD for Channel Sales:...

  • Strategic HR Business Partner

    2 weeks ago

    Hubli, Karnataka, India Able Design And Manufacturing Pvt Ltd Full time

    Job Summary:At Able Design And Manufacturing Pvt Ltd, we are seeking a highly skilled and experienced Human Resources Executive to join our team. As a key member of our HR department, you will be responsible for conducting recruitment and exit interviews, managing end-to-end recruitment processes, and reviewing compensation and benefits for all employees.Key...

  • SESSE-Hubli Channel Project

    2 weeks ago

    Hubli, India 2coms Full time

    Position :Senior Sales ExecutiveLine of Business : Natural VeneersLocation : HubliRole :ChannelProject SalesJob Responsibility :Meet Sales TargetProject Scouting & Architect/ Builder/ Contractor handlingHandling Dealer/ Distributor/ Channel PartnersLead GenerationDemand GenerationCompensation : Hike as per Industry NormsJD for Channel Sales:Delivering on...

  • Regional Sales Manager

    4 weeks ago

    Hubli, Karnataka, India DBS Bank Full time

    Job Title: Area Sales ManagerDBS Bank is seeking a highly motivated and experienced Area Sales Manager to join our team. As an Area Sales Manager, you will be responsible for driving sales growth and productivity across a designated area.Key Responsibilities:Recruit and train a team of sales professionals to achieve sales targets.Develop and implement sales...

  • Senior Sales Executive for Natural Veneers

    2 weeks ago

    Hubli, Karnataka, India 2coms Full time

    Job Title: Senior Sales Executive for Natural VeneersJob Summary: We are seeking a highly motivated and experienced Senior Sales Executive to join our team at 2coms. The ideal candidate will have a strong background in sales, with a focus on natural veneers. The successful candidate will be responsible for meeting sales targets, project scouting, and...

  • Deputy Manager

    4 weeks ago

    Hubli, Karnataka, India Mahindra Rise Full time

    Job Title: Deputy/Assistant ManagerCompany: Mahindra & Mahindra LtdJob Summary:We are seeking a highly motivated and experienced Deputy/Assistant Manager to join our team. The successful candidate will be responsible for leading the sales team, driving sales growth, and implementing sales strategies to achieve business objectives.Key Responsibilities:Lead...

  • Team Lead

    2 weeks ago

    Hubli, Dharwad, India SPECTRUM AV TECHNO CONSULTANTS Full time

    Description :We are seeking a highly motivated and skilled Team Lead specializing in Python, Machine Learning, and Analytics to join our innovative team. In this critical role, you will oversee a group of talented data scientists and analysts, guiding them in the development of cutting-edge solutions that leverage advanced analytics and machine learning...

  • On-Site P&ID Process Engineer

    7 days ago

    Hubli, Karnataka, India Snaphunt Full time

    The OpportunityThis leadership role offers a breadth of learning opportunities, positioning you at the forefront of on-site P&ID design and implementation.The JobKey ResponsibilitiesConduct on-site visits, gathering relevant data, collaborating with stakeholders, and understanding site-specific requirements.Develop and coordinate P&ID drawings at project...