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 conducting operations in more than 90 countries, fortrea is transforming drug and device development for partners and patients across the globe. 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 conducting operations in more than 90 countries, fortrea is transforming drug and device development for partners and patients across the globe. we are seeking a dedicated sr centralized study associate to join our team. the successful candidate will be responsible for: clinical systems & access management: managing clinical systems and access.maintaining study databases (ctms, iwrs, edc, etc.).supporting the study team in data review and other related activities.tracking and following up with cras for outstanding issues.generating study-specific reports.managing internal/external communications.assisting in ensuring training compliance for study teams.managing study payments (site and vendor). data review: following up with cras...
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 conducting operations in more than 90 countries, fortrea is transforming drug and device development for partners and patients across the globe. 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 conducting operations in more than 90 countries, fortrea is transforming drug and device development for partners and patients across the globe. we are seeking an experienced and highly motivated centralized study specialist i to join our team. this role involves managing clinical systems, supporting study documentation, ensuring compliance, and providing leadership and mentorship to junior team members. the successful candidate will play a pivotal role in the successful execution of clinical trials and contribute to process improvement initiatives. key responsibilities: clinical systems management: oversee and manage clinical systems.maintain study databases (ctms, iwrs, edc, etc.).support etmf management. study coordination: tr...
Core icf developer/writer and reviewer (centralized role) join or sign in to find your next job at fortrea . responsibilities: develop, review, finalize, and maintain clinical trial documents such as informed consent forms. apply knowledge of gcp guidelines, regulatory requirements, privacy standards, biological samples standards, therapeutic areas, and imps to review and develop icfs. ensure the content of the master icf aligns with the protocol and fully informs potential research subjects. write/edit documents in compliance with global industry standards and client-specific guidance. support development, review, and approval of master templates for protocol/site activation. create and revise training materials and plans. communicate effectively with stakeholders, including liaising with pm/designee regarding trends, issues, or safety concerns. skills: strong knowledge of drug development process and fda ind/nda requirements. understanding of clinical trial regulations including fda, gdpr, and gcp. knowledge of medical terminology and health literacy principles is a plus. proficiency in ms word and excellent communication skills. ability to influence, plan, prioritize, and mentor. requirements: university/college degree (medical degree preferred). 5+ years experience in writing and editing clinical trial documents. advanced english skills. strong knowledge of ich-gcp and applicable regulations. seniority level: mid-senior level. employment type: full-time. job function: engineering and information technology. this job posting is active. #j-18808-ljbffr...
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 conducting operations in more than 90 countries, fortrea is transforming drug and device development for partners and patients across the globe. 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 conducting operations in more than 90 countries, fortrea is transforming drug and device development for partners and patients across the globe. we are seeking an experienced and highly motivated senior centralized study specialist to join our team. this role involves managing clinical systems, supporting study documentation, ensuring compliance, and providing leadership and mentorship to junior team members. the successful candidate will play a pivotal role in the successful execution of clinical trials and contribute to process improvement initiatives. key responsibilities: clinical systems management: manage clinical systems, including ctms milestone updates at site/country/protocol levels.manage and review study documents and...
Job overview primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure ec/irb/third body/regulatory authority and any other local applications are made within the timelines agreed with project management and site readiness team and that documentation meets the specifications required by applicable regulations and sponsor. proactively interacts with ec/irb/third body/regulatory authorities to provide guidance regarding requirements. maintain awareness of current regulatory standards related to submissions. serve as local expert in project start-up activities for a particular country or region. act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues if suitable. summary of responsibilities maintain awareness of regulatory legislation, guidance, and practice in the assigned countries. coordinate, collect and organize data and information required by ec/irb/third body/regulatory authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable. compile and prepare routine submission filed to irb/iec/third body/regulatory authorities (e.g., inds/ctas) and liaise with them as applicable regarding submission/approval. liaise with internal and external vendors in the generation of regulatory authority submissions (as applicable). perform a review of final submission documents as ap...
Summary of responsibilities site management responsibility for clinical studies according to fortrea’s standard operating procedures, ich gcp guidelines, applicable project plans and sponsor requirements, including verification of study training records. conducts site monitoring responsibilities for clinical trials according to fortrea’s standard operating procedures (sops), ich guidelines and gcp; including pre-study, site initiation, process monitoring, routine monitoring, and close-out visits. prepares and implements project plans related to clinical monitoring responsibilities. ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements. safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on fortrea or client data management systems. confirms site regulatory documents and applicable etmf/sponsor documents are complete and current throughout the duration of the trial. guarantees that the study investigational product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements. ensures adherence to global quality control and cra performance metrics. ensures audit readiness at site level. acts in the project role of a lead cra as assigned. general on-site monitoring responsibilities: ensure the study staff who will conduct the protocol have received the proper materials and instructions to saf...
Join to apply for the workday financials architect role at fortrea 4 days ago be among the first 25 applicants join to apply for the workday financials architect role at fortrea get ai-powered advice on this job and more exclusive features. we are seeking a highly skilled workday fins (financials) architect to join our dynamic it team. the ideal candidate will have extensive experience in workday financials and how to successfully deliver the solution within the challenges of the cro environment. as a workday fins architect, you will be responsible for managing, optimizing, and strengthening our workday psa solutions to support our finance and operational needs which spans core accounting, banking and settlements, procurement, suppliers, and tax. remote based role in canada, india, mexico or united kingdom. summary of responsibilities lead the day-to-day management of the workday financials solutions. collaborate with cross-functional teams within operations and finance to gather requirements and translate them into effective workday financial configurations. align with workday psa and hcm architects to plan and deliver a roadmap aligned with enterprise leadership. continuously evaluate and optimize workday financials processes and configurations to enhance efficiency and user experience. understand workday financials product releases and oversee system regression testing. manage workday financials related projects, including planning, execution, monitoring, and reporting. support training and change management activities to maximize the effectiveness of the...
Tasks responsible for developing, reviewing, finalizing, and maintaining clinical trial documents such as informed consent forms. applies knowledge of gcp guidelines, regulatory requirements, regulatory framework of privacy standards and biological samples standards, therapeutic area(s), and investigational medicinal products (imps) to review and develop informed consent forms (icf). ensures that the content of the master informed consent form is consistent with the corresponding protocol and fully informs the subject of all information about the research study that a potential research subject will need to know to decide if they want to enroll in the study. ensures that research participants can easily understand the content and the scientific and medical language of the consent form. ensures that documents are written/edited in compliance with the global industry standards ensures client-specific guidance and requirements are included within the master informed consent form during development and review supports the development, review, and approval of master templates to ensure effective and timely execution of protocol/site activation create, review, and revise training material and plans to support the training requirements of the team. responsible for timely and appropriate communication to all stakeholders, as applicable liaise with pm/designee to communicate any trends, outstanding issues, safety concerns, or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety from the task assigned. skills strong knowled...
**job overview**: **summary of responsibilities**: - maintain awareness of regulatory legislation, guidance, and practice in the assigned countries. - compile and prepare routine submission filed to irb/iec/third body/regulatory authorities (e.g., inds/ctas) and liaise with them as applicable regarding submission/approval. - liaise with internal and external vendors in the generation of regulatory authority submissions (as applicable). - perform a review of final submission documents as applicable. - ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ich/gcp, sops and quality standards - prevent and escalate study issues appropriately and in a timely fashion. - perform other duties as assigned by management depending upon country and situational requirements with proper supervision [if applicable]. - ** in country specific tasks (global)**: - serve as primary contact for investigative sites and ensure documents required are collected in a timely manner. - collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance without supervision. - ensure high quality documents are filed and systems are updated on an ongoing and timely basis, making fortrea ready for an audit at any time. - participate in team and project meetings as applicable. - when needed, assist in the strategy de...
Join to apply for the workday financials architect role at fortrea 4 days ago be among the first 25 applicants join to apply for the workday financials architect role at fortrea get ai-powered advice on this job and more exclusive features. we are seeking a highly skilled workday fins (financials) architect to join our dynamic it team. the ideal candidate will have extensive experience in workday financials and how to successfully deliver the solution within the challenges of the cro environment. as a workday fins architect, you will be responsible for managing, optimizing, and strengthening our workday psa solutions to support our finance and operational needs which spans core accounting, banking and settlements, procurement, suppliers, and tax. remote based role in canada, india, mexico or united kingdom. summary of responsibilities - lead the day-to-day management of the workday financials solutions. - collaborate with cross-functional teams within operations and finance to gather requirements and translate them into effective workday financial configurations. - align with workday psa and hcm architects to plan and deliver a roadmap aligned with enterprise leadership. - continuously evaluate and optimize workday financials processes and configurations to enhance efficiency and user experience. - understand workday financials product releases and oversee system regression testing. - manage workday financials related projects, including planning, execution, monitoring, and reporting. - support training and change management activities to maximize the effectivenes...
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