Job Overview


Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.


Essential Functions


Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of... work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.


Qualifications


Bachelor's Degree Degree in Scientific discipline or Health Care preferred.
Requires at least 1 year of on-site monitoring experience.
Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
Good therapeutic and protocol knowledge as provided in company training.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
Written and verbal communication skills including good command of English language.
Organizational and problem-solving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients. more

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries, apply to join the sales team.

Job Description

Overview:


The Core Diabetes Model is a disease-simulation model used to inform health policy decisions and conduct economic evaluations for interventions aimed at controlling diseases by delaying the occurrence of their complications.
You will support the development team in refactoring and optimizing the existing C++ codebases with outlook to their extension to new... therapeutic areas.
The ideal candidate will possess a junior/middle C++ technical background with passion for writing clean, efficient code as well as a genuine interest in developing code for the healthcare sector.
If you are interested in disease and health-care related processes simulation modelling and wish to apply your technical skills to help inform healthcare decision making, this is the role for you.


Job Activities:


Work with the team in reviewing and refactoring legacy codebases.
Work with the team to extend the current models with new features, diseases and comorbidities.
Implement best practices in software design and development.
Ensure code quality through rigorous testing and code reviews.
Contribute to the continuous improvement of development processes.
Co-writing code documentation and technical reports (Word, PPT, Excel), inside and outside the team


Qualifications


BSc degree in Medical/Biomedical sciences/Engineering, or Mathematics
Demonstrable interest in population health science, public health, epidemiology
Understanding of disease modelling, healthcare analytics and/or medical statistics
Minimum of 3 years of experience in C++ development, with proficiency in C++17 or later versions.
Proven experience working with large scientific codebases (200,000 - 300,000 lines of code or more).
Hands-on experience with Visual Studio 2017 or newer, toolkit v141 or newer.
Experience with SQL databases and writing efficient queries.
Proficiency in software version control systems, particularly Git.
Strong background in object-oriented programming (OOP).
Solid understanding and practical application of design patterns.
Experience with unit testing frameworks (e.g., Google Test).
Excellent problem-solving skills and attention to detail.
Strong oral/written English communication skills.


Preferred Qualifications:


Experience with multi-threading and concurrency.
Knowledge of modern software development methodologies (e.g., Agile, Scrum, Extreme Programming).
Familiarity with continuous integration/continuous deployment (CI/CD) pipelines.
Familiarity with performance optimization techniques.
Experience with cross-platform development.
Experience with debugging and profiling tools. more

Job Overview


Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.


Essential Functions


Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of... work and Good Clinical Practice.
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.


Qualifications


Bachelor's Degree Degree in scientific discipline or health care preferred. Req
Requires at least 2 years of year of on-site monitoring experience. Req
Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Good therapeutic and protocol knowledge as provided in company training.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
Written and verbal communication skills including good command of English language.
Organizational and problem-solving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients. more

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Job Description

Primary Responsibility


Ensure ICSR case processing and related activities comply with regulatory requirements, company procedures, and PV agreements at local, regional, or global levels.


Inbound & Outbound ICSR Case Management


Handle receipt, assessment, and processing of safety information from various sources.
Enter safety data into the Global Inbound... Receipt System (GIRS).
Provide safety information to partners within timelines.
Perform data entry for complex cases and follow-up for additional information.
Assist in quality review and translation of safety information.
Monitor and report ICSRs to Competent Authorities (CAs) or Business Partners (BPs).
Support LSO oversight and escalate non-conformance.
Liaise with stakeholders for case processing requirements.


Other Activities


Support vendor training, case review, and oversight.
Screen local literature for ICSRs and safety signals.
Conduct periodic reconciliation activities.
Respond to ad hoc requests and support innovation roll-out.
Coordinate cross-country case management activities.
Write or review procedural documents.
Mentor junior staff and quality check their work.
Lead or support critical projects.


Education & Experience Requirements


Degree in life, health, or pharmaceutical sciences (e.g., Pharmacist, Medical Doctor, Biologist).


Essential Knowledge & Skills


Knowledge of general medicine, pharmacy, or clinical practice; proficiency in medical terminology.
Familiarity with ICSR-related PV procedural documents.
Expert knowledge of GIRS and/or OST modules.
Ability to prioritize and meet strict timelines.
Excellent communication skills in local and English languages.
Ability to negotiate and communicate with customers.
Understanding of pharmacovigilance legislation. more

Job Overview


Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.


Essential Functions


Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems... (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
Assist with periodic review of study files for completeness.
Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.


Qualifications


High School Diploma or equivalent Req
3 years administrative support experience.
Equivalent combination of education, training and experience.
Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
Written and verbal communication skills including good command of English language.
Effective time management and organizational skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
Knowledge of applicable protocol requirements as provided in company training. more

The Site Monitor Educator is responsible for overseeing and coordinating the activities of site monitors to ensure the successful execution of clinical trials. This role involves ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), and company standards. The Site Monitor Educator will act as a liaison between the clinical trial sites and the sponsor, providing guidance... and support to site monitors and ensuring the integrity and quality of the data collected.

Role Type: 6-month contract with a phased-work schedule

Key Responsibilities:

Leadership and Supervision:


Ensure that site monitors adhere to study protocols, regulatory requirements, and company SOPs.
Coordinate and oversee site monitoring activities to ensure timely and accurate data collection.


Site Management:


Develop and maintain strong relationships with clinical trial sites.
Conduct site visits to ensure compliance with study protocols and regulatory requirements.
Address and resolve any issues or concerns raised by site monitors or clinical trial sites.


Monitoring:


Monitoring will entail review of Informed Consent Forms, data entry on the RWE Box folder, Trial master file and source documents.
Post monitoring of the sites, Site Monitor Lead is to complete site visit reports, File notes and CAPAs and do site retaining as needed.


Quality Assurance:


Review and approve monitoring reports to ensure accuracy and completeness.
Implement quality control measures to ensure data integrity and compliance with GCP.
Conduct regular audits of site monitoring activities and provide feedback for improvement.


Regulatory Compliance:


Ensure that all site monitoring activities comply with applicable regulatory requirements, including ICH guidelines.
Site Monitor Educatory to complete regulatory reports and submit to regulatory bodies as required.
Stay updated on changes in regulatory requirements and industry best practices.


Communication and Collaboration:


Serve as the primary point of contact between the sponsor and clinical trial sites.
Facilitate effective communication and collaboration between site monitors, clinical trial sites, and other stakeholders.
Provide regular updates to the Clinical Operations Manager on the status of site monitoring activities.


Qualifications:


Bachelor’s degree in life sciences, nursing, or a related field. Advanced degree preferred.
Minimum of 5 years of experience in clinical research, with at least 2 years in a supervisory or lead role.
In-depth knowledge of GCP and ICH guidelines.
Ability to travel as required.


Skills:


Ability to create and implement effective training programs.
Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
Strong understanding of pharmacology and medication therapies.
Excellent communication and interpersonal skills.
Proficient in delivering engaging and informative presentations.
Ability to explain complex medical information clearly and effectively.
Strong analytical and problem-solving skills.
Attention to detail and ability to work independently.
Ability to manage multiple priorities and meet deadlines. more

Work closely with clients and other internal functional groups by providing epidemiology leadership for global public health research programs, under the supervision of senior staff.  Design methodologically sound studies to meet project objectives of global public health stakeholders. Provide input on and design real world studies, which include but are not limited to burden of disease studies,... surveillance studies, infectious disease modeling, and comparative safety and effectiveness of treatments and vaccines. Conduct and review analyses, evaluate and provide reporting of studies. 

May contribute to new business development (as appropriate) to maintain and strengthen client base. Provides input and feedback on the development of best practices in infectious disease epidemiology and global public health research and other internal initiatives

Essential Functions


Leads design and implementation of epidemiology methods in public health studies using real world data, including (but not limited to) drug safety and effectiveness studies, infectious disease modeling, and other observational or low intervention studies using real world data and/or methodology.
Support senior staff on specific research initiatives as needed. 
Serves as project lead on smaller projects or in support of project lead on larger client facing or internal projects.
Authors of protocols, reports and other study documents with independent, critical thinking to ensure quality and completeness of output
Reviews and provides relevant epidemiological input to statistical analysis plans and analysis output.
Interacts with clients and involves senior staff as needed.
Identifies client-related, budget-related and internal issues that may require attention or escalation.
Use best efforts to complete work with available budget.
Contributes to intra- and interdepartmental process improvement to achieve "best practices" and to support effective delivery and quality of deliverables.
May generate content and direction for business development proposals on smaller projects with input and oversight from senior staff.
May represent IQVIA externally through conference presentations.
May oversee or conduct statistical analysis as needed.
May contribute to the development of high quality proposals for new projects. 
May contribute to the development of best practices in global public health epidemiology and infectious disease research and other internal initiatives. 


Qualifications


Master's Degree: Graduate education in epidemiology, pharmacoepidemiology, public health with concentration in epidemiology, or relevant scientific field and 5 years relevant experience (required) or,
Ph.D. with 2 years relevant experience (required)
Sound methodological training in epidemiology, pharmacoepidemiology, infectious disease epidemiology, public health with concentration in epidemiology, or related area relevant to global public  health research.
An understanding of the Global Public Health challenges and needs and how Epidemiological methods can be used to address these
Ability to design, plan and conduct observational studies appropriate for a variety of global health contexts.
Excellent oral and written communication skills, medical writing experience beneficial.
Ability to establish and maintain effective working relationships with coworkers, managers and clients in a global and interdisciplinary environment.
Exceptional attention to detail and the ability to effectively prioritize and manage multiple tasks.
Ability to work collaboratively with diverse team members.
Ability to perform analyses and statistical programming in SAS, R or other programming languages.
Must be highly organized and self-motivated with ability to determine and meet objectives. more

Job Overview


Supports and manages relationships with pharmacies in global clinical trials up to Phase III with a special focus on clinical trials conducted in the region
Contact for IMP-rning CROs and site personnel on IMP handling
Liaises with GCP QA and supports CTSM GCP related activities
Supports on appropriate CTSM GCP risk communication and ensures CTSM GCP requirements are... met
Manages complaints, deviations, changes, and other quality incidents for GCP topics
Travel requirement: 1elated and Clinical Trial Supply Management (CTSM) -related questions for CROs/ Sites / pharmacies
Contributes to trai5%


Qualifications


Relevant professional experience (usually +3 years) in Clinical Supply or Clinical Research in Pharmaceutical/Biotech industry or CRO setting or any equivalent e.g., Pharmacy Services
Relevant completed university education in Pharmacy, experience as a Clinical Pharmacist or in an equivalent role
Deep understanding of country-specific requirement and standards for Clinical Trials conducted in the region
Deep Knowledge about Pharmacy Manuals / Pharmacy Questionnaires
Deep Knowledge about GCP principles (e.g., Ethical Principles, Adequate Drug Information, etc.)
Business-professional English and local language skills
Self-motivated with strong problem-solving and learning skills
Ability to create independent analyses and develop new solutions
Excellent organizational and communicative skills
Enjoys working in a team
Openness to explore on new topics for setting up the trend more