
Clin Review Spec
1 day ago
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
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Clin Data Spec
1 week ago
Bengaluru, India IQVIA Full timeJob 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 Functional...
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Clin Data Spec
5 days ago
Bengaluru, Karnataka, India Novasyte Full timePerform 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 -...
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Clin Data Spec
1 week ago
Bengaluru, India IQVIA Full timeJob Overview Provide comprehensive data management expertise to Clinical Data Management (CDM) to provide efficient, quality data management products that meet customer needs. Provide leadership either in the role of the Data Operations Coordinator (DOC), the role of the Data Team Lead (DTL) or in a leadership role in a specific CDM task (e.g., lead of a...
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Document Review Spec I
1 week ago
Bengaluru, India PPD Full timeThe 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, serious...
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Document Review Spec I
1 week 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...
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Clin Process Spec 2
1 week ago
Bengaluru, Karnataka, India IQVIA Full timeRole: An exciting opportunity to contribute to the development of first-in-class specialty medicines for patients in need within our healthcare division. You will be part of an established team that supports study teams across Phase I to Phase IV (both interventional and non-interventional) and Investigator Sponsored Studies, with or without CRO involvement....
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Doc Review Spec I/ii
1 day ago
Bengaluru, India PPD Full timeThe 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,...
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Centralized Study Spec I
1 week ago
Bengaluru, Karnataka, India Fortrea Full timeAs 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...
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Cats & Specs Admin - Resource Center India
2 weeks ago
Bengaluru, Karnataka, India SBM Offshore Full time**Req Id**:14918**Job Family**:Engineering - Piping**Location**:Bangalore, IN, 560071**Job description**: - Knowledge of international codes and standards on ASME & API. - Project specific customization of system and writing macros. - Proficient with the use of E3D/PDMS Design, Draft, Paragon Module, Cats and Specs Admin - Capable of creating catalogues of...
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Spec Analytics Analyst
2 weeks ago
Bengaluru, Karnataka, India Early Career Full time ₹ 9,00,000 - ₹ 12,00,000 per yearThe Spec Analytics Analyst is a developing professional role. Applies specialty area knowledge in monitoring, assessing, analyzing and/or evaluating processes and data. Identifies policy gaps and formulates policies. Interprets data and makes recommendations. Researches and interprets factual information. Identifies inconsistencies in data or results,...