- Lead and contribute to Clinical Data Standards planning, definition, development, validation and support within assigned standards discipline (domain) including the development and maintenance of associated metadata, documents, business rules and guidelines where applicable.
- Serves as the primary contact for global data acquisition and tabulation OR analysis and data submission standards for core global and/or assigned Therapeutic Area ensuring timely and quality deliverables
- Define and deliver to robust, priority driven standards development plans for assigned area to ensure agreed deliverables are met and assigned resources are fully and effectively utilized.
- Accountable for driving the efficient, high quality and timely implementation of new standards and/or updates to standards; In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development, lead the accurate translation of scientific and analytical requirements into efficient, compliant standards.
- Support and ensure the appropriate and efficient governance and approval of global and project/study specific clinical data standards liaising with governance boards as needed.
- Lead the technical review and assessment of industry and regulatory standards and guidelines supporting regular gap/impact analysis and implementation of action plans where needed.
- Communicate effectively with the partners and customers; Establish and maintain strong collaborative relationships with Data Operations, Biostatistics and Clinical Development groups supporting the development and use of Clinical Data Standards.
- Lead and contribute to the development, maintenance and training of relevant clinical standards systems and processes. Act as an expert consultant providing Clinical Data Standards input to all relevant areas including; electronic data capture/database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient reported outcomes, metadata management and/or other clinical data management or analysis data and TFL-related systems.
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Gynaecologist
1 week ago
Emami Corporation Limited Mumbai, IndiaPerforming annual and regular examinations on patients to diagnose various gynecological conditions. · - Recording and updating patients' medical histories. · - Advising patients on suitable birth control options. · - Performing various diagnostic tests on patients, which include ...
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Gynecologist
5 days ago
Millat medical centre Mumbai, IndiaPerforming annual and regular examinations on patients to diagnose various gynecological conditions. · - Recording and updating patients' medical histories. · - Advising patients on suitable birth control options. · - Performing various diagnostic tests on patients, which include ...
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Gynaecologist
1 day ago
The Crossword School Vasai, India**Responsibilities**: · - Performing annual and regular examinations on patients to diagnose various gynecological conditions. · - Recording and updating patients' medical histories. · - Advising patients on suitable birth control options. · - Performing various diagnostic tests ...
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Sr Piping Materials Engineer
6 days ago
Black & Veatch mumbai, India Full timeJob Summary Functions as a technical specialist or in a lead role. Under general direction, develops and applies advanced engineering techniques, concepts and approaches to complex engineering problems. May provide technical guidance over a group or supervise engineering staff o ...
Sr Principal Clin Data Stds Specialist - Navi Mumbai, India - Novartis
Description
Your responsibilities include, but are not limited to: