Spec I PSS
3 weeks ago
Roles & Responsibilities:
Ensuring that the IST investigator is providing study updates as applicable to the customer viz. regulatory updates, enrolment data, confirming that safety information is being transferred to customer as required, notification of any amendments to either the protocol or informed consent
Impart process trainings within the team for sign off and refresher trainings as applicable
Supporting the leads on preparation of the dashboards as required on a regular interval
Ensuring that the agreed upon contractual milestones are being met and raising to customer for any threats to the milestones or if any milestones are missed
Monitoring eTMF compliance based on the eTMF filing plan and providing guidance to the Investigator site staff via raised queries in the BMS FastTrack communication portal
Based on the Investigators enrolment plan, validate the initial drug supply demand and provide forecasting updates to BMS as required
Review Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guideline.
Review protocol and protocol amendments to assure compliance with sponsor requirements, reconfirm completeness and to assure compliance with Good Clinical Practice (GCP) guidelines
Support presentations for customer governance calls
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
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Spec I Pss
3 weeks ago
Mumbai, India Fortrea - Organic 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. With over 19,000 staff...
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Spec I PSS
2 weeks ago
Mumbai, Maharashtra, India Fortrea Full timeAs a prominent global contract research organization (CRO) with a strong focus on scientific excellence and extensive experience in clinical development, Fortrea offers pharmaceutical, biotechnology, and medical device clients a diverse array of clinical development, patient access, and technology solutions spanning over 20 therapeutic areas. With a...
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Spec I PSS
3 weeks ago
mumbai, India CSS Fortrea Scientific Pvt Ltd 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. With over 19,000 staff...
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Spec I Pss
2 weeks ago
Navi Mumbai, Maharashtra, India Labcorp Full timeLabcorp Drug DevelopmentAs a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired...
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Spec I Pss
2 months ago
Navi Mumbai, India Labcorp Full timeImplement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables Ensure compliance of operations with governing regulatory requirements Create, maintain and assume accountability for a culture of high...
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Spec I Pss
2 months ago
Navi Mumbai, India Labcorp Full timeLabcorp Drug Development As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired...
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Spec I Pss
3 weeks ago
Navi Mumbai, India Labcorp Full timeImplement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables Ensure compliance of operations with governing regulatory requirements Create, maintain and assume accountability for a culture of high...
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Spec I Pss
3 weeks ago
Navi Mumbai, India Labcorp Full timeBachelors - Life sciences 2-4 Years Efficiency in conducting literature searches for authoring various types of reports Write various safety reports (or part of such reports) for global regulatory submissions for Labcorp’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports,...
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Spec Ii Pss
3 months ago
Navi Mumbai, India Labcorp Full timeImplement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables - Ensure compliance of operations with governing regulatory requirements - Create, maintain and assume accountability for a culture of high...
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Spec Ii Pss
2 weeks ago
Navi Mumbai, Maharashtra, India Labcorp Full timeWrite and review various safety reports (or part of such reports) for global regulatory submissions for Sciformix's clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports Write Investigator brochures and sections of protocols Write Clinical Study Reports (in whole or...
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Junior I/o Data Support
3 months ago
Mumbai, India Phantom Digital Effects Pvt Ltd Full timeCoordinating the transfer of assets. - Managing data to ensure storage resources are used efficiently. - Archiving and restoring data if required. - Ensuring the security policies and procedures of PhantomFX and its clients are fully - adhered to. - Coordinating with artists, Production and Editorial to ensure required assets are - available. - Fulfil client...
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Safety Science Coordinator I
4 weeks ago
mumbai, India CSS Fortrea Scientific Pvt Ltd 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. With over 19,000 staff...
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Spec. Regulatory Reporting
4 weeks ago
Mumbai, India Credit Suisse Full time**Your field of responsibility** Your responsibilities include: - Responsibility of ensuring the Company’s financial records are in compliance GAAP (IND AS, US GAAP and Indian GAAP), Accounting Policies & Standards and respective local regulatory requirements, Internal Control requirements, and procedures - Efficient and effective timely delivery of...
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Spec. Regulatory Reporting
2 weeks ago
Mumbai, Maharashtra, India Credit Suisse Full timeYour field of responsibilityYour responsibilities include: Responsibility of ensuring the Company's financial records are in compliance GAAP (IND AS, US GAAP and Indian GAAP), Accounting Policies & Standards and respective local regulatory requirements, Internal Control requirements, and procedures Efficient and effective timely delivery of External and...
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Remote Resolution Spec
3 weeks ago
Mumbai, Maharashtra, India NCR Atleos Full timeAbout NCR NCR Corporation (NYSE: NCR) is a leader in transforming, connecting and running technology platforms for self-directed banking, stores and restaurants. NCR is headquartered in Atlanta, Ga., with 38,000 employees globally. NCR is a trademark of NCR Corporation in the United States and other countries. - Position Description - The Remote Resolution...
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Remote Resolution Spec
2 weeks ago
Mumbai, Maharashtra, India NCR Atleos Full timeAbout NCR NCR Corporation (NYSE: NCR) is a leader in transforming, connecting and running technology platforms for self-directed banking, stores and restaurants. NCR is headquartered in Atlanta, Ga., with 38,000 employees globally. NCR is a trademark of NCR Corporation in the United States and other countries. Position Description The Remote Resolution...
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Product Sales Specialist
4 weeks ago
Mumbai, India Cisco Full timeWho We Are The name ThousandEyes was born from two big ideas: the power to see things not ordinarily possible and the ability to collect insights from a multitude of vantage points. As organizations rely more on cloud services and the Internet, the network has become a black box they cannot understand. Our Internet and cloud intelligence platform...
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Product Sales Specialist
1 month ago
Mumbai, India Cisco Full timeWho We Are The name ThousandEyes was born from two big ideas: the power to see things not ordinarily possible and the ability to collect insights from a multitude of vantage points. As organizations rely more on cloud services and the Internet, the network has become a black box they cannot understand. Our Internet and cloud intelligence platform...
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Sr. Application Engineer I
2 weeks ago
Mumbai, Maharashtra, IN Johnson Controls International Full timeBuild your best future with the Johnson Controls teamAs a global leader in smart, healthy and sustainable buildings, our mission is to reimagine the performance of buildings to serve people, places and the planet. Join a winning team that enables you to build your best future! Our teams are uniquely positioned to support a multitude of industries across...
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Svc Spec-surface Well Testg, I
3 weeks ago
Mumbai, India Halliburton Full timeWe are looking for the right people — people who want to innovate, achieve, grow and lead. We attract and retain the best talent by investing in our employees and empowering them to develop themselves and their careers. Experience the challenges, rewards and opportunity of working for one of the world’s largest providers of products and services to the...