Spec I PSS
2 weeks ago
As 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 workforce of over 19,000 employees operating in 90+ countries, Fortrea is revolutionizing the landscape of drug and device development for partners and patients worldwide.
Roles & Responsibilities:
- Ensure IST investigator provides study updates to customers including regulatory updates, enrollment data, safety information, and notifies of any protocol or informed consent amendments
- Conduct process trainings within the team and provide refresher trainings as needed
- Assist in preparing dashboards at regular intervals under the guidance of team leads
- Monitor and ensure compliance with contractual milestones, escalating any risks or missed milestones to the customer
- Monitor eTMF compliance as per the filing plan, providing guidance to Investigator site staff via queries in the BMS FastTrack communication portal
- Validate initial drug supply demand based on Investigators enrollment plan and offer forecasting updates to BMS
- Review Country/Site Informed Consent Form for compliance with sponsor and regulatory requirements, as well as Good Clinical Practice (GCP) guidelines
- Review protocol and amendments to ensure adherence to sponsor requirements and GCP guidelines
- Support in preparing presentations for customer governance calls
Fortrea actively seeks dynamic problem-solvers and innovative individuals who resonate with our mission to overcome obstacles in clinical trials. Our dedicated focus is on transforming the development process to facilitate the prompt delivery of groundbreaking ideas and treatments to patients in need. Become part of our exceptional team and engage in a collaborative environment that fosters personal development, empowering you to create a significant global impact.
-
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...
-
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...
-
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...
-
Design and Detail Engineer
2 months ago
Navi Mumbai, Maharashtra, India timesjobs Full timeJob Description:Detailed Work Profile Experience: 6 years of relevant experience in Thermal/MechanicalJob Brief: Designing Solid fuel-fired boilers, Oil & Gas Fired Boilers, and Thermic fluid heaters according to client specifications, including Thermal/configuration design, conceptual design with the preparation of P & I diagrams. Block layouts and...
-
Design and Detail Engineer
2 weeks ago
Navi Mumbai, Maharashtra, India timesjobs Full timeJob Description:Detailed Work Profile Experience: 6 years of relevant experience in Thermal/MechanicalJob Brief: Designing Solid fuel-fired boilers, Oil & Gas Fired Boilers, and Thermic fluid heaters according to client specifications, including Thermal/configuration design, conceptual design with the preparation of P & I diagrams. Block layouts and...
-
Design and Detail Engineer
4 weeks ago
Navi Mumbai, Maharashtra, India timesjobs Full timeJob Description:Detailed Work Profile Experience: 6 years of relevant experience in Thermal/MechanicalJob Brief: Designing Solid fuel-fired boilers, Oil & Gas Fired Boilers, and Thermic fluid heaters according to client specifications, including Thermal/configuration design, conceptual design with the preparation of P & I diagrams. Block layouts and...
-
Exec. Reg. Sales
2 weeks ago
Navi Mumbai, Maharashtra, India Reliance Industries Full timePosted Date:14 Mar 2024Function/Business Area:PetrochemicalsLocation:Navi MumbaiResponsibilities:a)Consolidate, finalize and monitor the Sales Plan and Actuals for the Territory : Monthly and Annual.b) Generate orders on a daily basis by following up with customers and channel partners.c) Monitor actual customer off take vs. plan (Sales Plan, MOU, and Annual...
-
Head Engineer
2 weeks ago
Mumbai, Maharashtra, India Almighty HRD Consultants Full timeHi, We are hiring "Head Engineer" for our client Aditya Birla Renewables Limited for Mumbai Location.Salary - 55 to 75 LPAExp : yrsNotice Period - 60 daysQualification : BTECH, MTECH.JDSupporting Actions (a) To carry out detailed designs & drawings including system engineering in a time bound manner for Solar & Wind Projects. Develop expertise for detailed...
-
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...
-
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...
-
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...
-
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,...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
Software Development Engineer
2 months ago
Mumbai, India Upstox Full timeResponsibilities: . Design and build efficient, scalable systems that are used by millions of people.. Own what you build as you create, test and refine what’s under the hood of our pages and services.. Implement and maintain features, improve performance and reliability in our frontend web experiences. Interact with Product, Design and Engineering...
-
Software Development Engineer
4 weeks ago
Mumbai, India Upstox Full timeResponsibilities: . Design and build efficient, scalable systems that are used by millions of people.. Own what you build as you create, test and refine what’s under the hood of our pages and services.. Implement and maintain features, improve performance and reliability in our frontend web experiences. Interact with Product, Design and Engineering...
-
Software Development Engineer
4 weeks ago
mumbai, India Upstox Full timeResponsibilities: . Design and build efficient, scalable systems that are used by millions of people.. Own what you build as you create, test and refine what’s under the hood of our pages and services.. Implement and maintain features, improve performance and reliability in our frontend web experiences. Interact with Product, Design and...