Clin Review Spec

7 days ago

Bengaluru, India PPD Full time

The objective of a Senior Clinical Review Specialist is to review patient data in accordance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs)/Working Practice Documents (WPDs) and Data Validation Manuals (DVMs). Clinical Review Specialists will be expected to liaise with colleagues in other functional groups as required, and to communicate with management for all data review activities within their allocated studies. Responsibilities may include, but are not limited to:

- Reads and understands project protocols and Data Validation Manuals (DVM)
- Reviews patient data in accordance with the Clinical Listings Review Plan in the DVM
- Identifies data issues and works with PPD team and study sites to resolve
- Ensures data accuracy according to departmental operating procedures
- Ensures applicable data review activities are conducted accurately, and all related deliverables are completed to quality expectations, within budget and on time
- Provides support, guidance and direction on clinical data review to the CDM project team including consultation related to Listing Review and related sections of the DVM
- Provides clinical review training to all CDM staff performing clinical review activities
- Participates in the development and implementation of processes, procedures and training for the data management function, as directed

  • Clin Data Spec

    3 days ago

    Bengaluru, Karnataka, India IQVIA Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job Description Job Overview Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or...

  • Assoc Clin Data Coord

    3 weeks ago

    Thane, Hyderabad, Bengaluru, India IQVIA Full time

    Job Description Job Title / Primary Skill:Assoc Clin Data Coord Years of Experience:1-2 Years Job Location:Bangalore/Thane/Hyderabad Must Have Skills:Clinical data management, data management, rave, conduct, closeout, start up Good To Have Skills:Rave Job Description Provide basic and some comprehensive data management expertise to the Clinical Data...

  • Clin Data Spec

    2 weeks ago

    Bengaluru, Karnataka, India Novasyte Full time

    Perform comprehensive data management tasks including data review, query generation and query resolution. - Ongoing Data Reconciliation of all data streams - Generate and drive resolution of data queries (in EDC and back-end database) - Study related meetings/teleconferences - Study Closeout/Archiving Activities - Create and provide status/metric reports -...

  • Document Review Spec I

    2 weeks ago

    Bengaluru, India PPD Full time

    **JOB DESCRIPTION**: - The Document Review Specialist is responsible for the thorough review of documents created within or outside of PPD in order to ensure quality of a standard that meets or exceeds client's expectations. These documents include, but are not limited to, regulatory submissions (sections of NDAs, BLAs, PLAs, INDs, CTDs), integrated...

  • ▷ High Salary! Manager Clin Data Mgmt

    3 weeks ago

    Kolkata, Bengaluru, Cochin / Kochi / Ernakulam, India IQVIA Full time

    Job Description Job Title / Primary Skill:Manager Clin Data Mgmt Years of Experience:12-16 Years Job Location:Pune/Hyderabad Must Have Skills:Clinical data management, data management, rave, Line management Good To Have Skills:Rave Job Description Manage and support team of Data Management professionals to efficiently produce databases that meet...

  • Doc Review Spec I/ii

    7 days ago

    Bengaluru, India PPD Full time

    The Senior Document Review Specialist is responsible for the thorough review of documents created within or outside of PPD in order to ensure quality of a standard that meets or exceeds client's expectations. These documents include, but are not limited to, regulatory submissions (sections of NDAs, BLAs, PLAs, INDs, CTDs), integrated clinical study reports,...

  • Centralized Study Spec I

    2 weeks ago

    Bengaluru, Karnataka, India Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in...

  • Centralized Study Spec I

    3 days ago

    Bengaluru, Karnataka, India Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clin Process Coord

    2 weeks ago

    Bengaluru, India IQVIA Full time

    Job Overview Provide project related assistance for all assigned project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics. Essential Functions - Work on visit tracking in CTMS for Investigator...

  • Spec Analytics Analyst

    7 days ago

    Bengaluru, Karnataka, India Citi Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    TTS Analytics C10 What do we do?The TTS Analytics team provides analytical insights to the Product, Pricing, Client Experience and Sales functions within the global Treasury & Trade Services business. The team works on business problems focused on driving acquisitions, cross-sell, revenue growth & improvements in client experience.The team extracts relevant...