Centralized Study Spec I

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...

Position provides process, control, coordination, and approval of clinical trial documents. Position is responsible for ECD, Phase I-IV electronic trial master file (eTMF). ¨ Maintains an understanding of applicable regulatory requirements. ¨ Managing electronic Trial Master Files (eTMF), (Trial, Country and Site artifacts) for clinical studies in...

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...

Manage study documents such as study level, country level and site level - Maintain study databases (CTMS, IWRS, EDC etc.) - Support study team in e-TMF management activities - Support study team in data review and support activities - Upload, check, correct and maintain study documents for document review in the study eTMF regionally. - Send study documents...

Follow all applicable departmental Standard Operating Procedures and Work Instructions. Complete required trainings according to required timelines. Complete day-to-day tasks ensuring quality and productivity. Maintain project and technical documentation in an appropriate manner. Perform checks to ensure quality of work completed Ensure timely escalation as...

1. Follow all applicable departmental Standard Operating Procedures and Work Instructions. 2. Complete required trainings according to required timelines. 3. Complete day-to-day tasks ensuring quality and productivity. 4. Maintain project and technical documentation in an appropriate manner. 5. Perform checks to ensure quality of work completed 6. Ensure...

Follow all applicable departmental Standard Operating Procedures and Work Instructions. Complete required trainings according to required timelines. Complete day-to-day tasks ensuring quality and productivity. Maintain project and technical documentation in an appropriate manner. Perform checks to ensure quality of work completed Ensure timely escalation as...

**Responsibilities**: - Support the payment of assigned studies which could include study set-up, maintenance, timely and accurate payment to the sites, as well as issue resolution and study reconciliation. - Provide excellent customer service and site issue resolution - Assist in setting entering study budgets and payees - Review Electronic Data Capture...

Support the payment of assigned studies which could include study set-up, maintenance, timely and accurate payment to the sites, as well as issue resolution and study reconciliation. Provide excellent customer service and site issue resolution Assist in setting entering study budgets and payees Review Electronic Data Capture updates and determine when...

Job Overview Provide project related assistance to assigned project teams. Ensure all work is conducted in accordance with standard operating procedures, policies, good clinical practices and applicable regulatory requirements. Meeting quality and timeline metrics. Essential Functions - Complete appropriate role-specific training to perform job duties.; -...

Job Overview Provide project related assistance to assigned project teams.; Ensure all work is conducted in accordance with standard operating procedures, policies, good clinical practices and applicable regulatory requirements.; Meeting quality and timeline metrics.; Essential Functions - Complete appropriate role-specific training to perform job...

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

Study Support Assistant ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Study Start Up Associate I to join our diverse...

Role OverviewThe Senior Central Monitoring Manager will be responsible for overseeing the central monitoring activities for multiple studies and ensuring accurate tracking and status reporting of studies within their remit. This includes managing a portfolio of studies for a customer and serving as the primary point of contact.The successful candidate will...

Role: 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....

**Brief Description about the Project** The study entitled “India Child Growth Standards Research Initiative: A Prospective Cohort Study to Develop Growth and Development Standards in 0 to 24 months Indian Children”- **_UNNATI_**, is a prospective cohort study planned to be conducted across 6 regions (North, South, East, West, Central and Nort-East) of...

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 Functional...

Job Description - Employee Central Certified with minimum two end to end implementation experience. - Should have in depth understanding of EC data models. - Should be adept in configuring EC workflows, writing complex business rules. - Well versed with the EC APIs - Experience in writing Functional Spec and Conducting Workshop - Provide functional support...

Company OverviewNovo Nordisk is a global leader in healthcare, with a 100-year legacy of driving change to defeat serious chronic diseases. Our commitment to innovation and excellence has made us one of the 20 most valuable companies in the world by market cap. With over 72,000 employees worldwide, we recognize the importance of diverse perspectives and...