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

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions

Under general supervision, serve as Single Point of Contact (SPOC) in... assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
Distribute completed documents to sites and internal project team members.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Review and provide feedback to management on site performance metrics.
Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
Inform team members of completion of regulatory and contractual documents for individual sites.
Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives.

Qualifications

Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
In-depth knowledge of clinical systems, procedures, and corporate standards.
Good negotiating and communication skills with ability to challenge, if applicable.
Effective communication, organizational, and interpersonal skills.
Ability to work independently and to effectively prioritize tasks.
Ability to manage multiple projects.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.
Understanding of regulated clinical trial environment and knowledge of drug development process.
Ability to establish and maintain effective working relationships with coworkers, managers and clients. more

Job Overview

Therapeutic Strategy Lead (TAL) is performing, managing and coordinating activities for complex opportunities/ projects to support the bid defense. TAL utilizes multiple data sources to perform analysis, formulate recommendations and present to internal and external stakeholders (client-facing role).

Essential Functions

Accountable to ensure IQVIA planning services are... providing a competitive edge in winning new business. Take independent responsibility for the creation of complex country and/or enrollment strategies or site lists in support of opportunities including but not limited to requests for proposals, early engagements, re-bids and potentially awarded studies
Support the development of materials related to feasibility and/or enrollment strategies or site lists for customer bid defense meetings or internal customers such as Therapeutic Strategy Leads, Medical Leads or business development Recommend solutions for key stakeholders and IQVIA project teams
Prepare for planning meetings by conducting complex research into therapeutic areas using databases, scientific literature, the internet and expert medical knowledge
Lead complex planning meetings with internal stakeholders including Medical Directors, Therapeutic Strategy Leads, Business Developers, Sales Staff and Program Directors. Present results of data gathering and analysis activitiesServe as a SME for planning tools, demonstrate an depth understanding of system features and functions to know what features are best used to accomplish an accurate country, site or enrollment strategy

​​Qualifications

Bachelor's Degree, preferably from Healthcare or Biological Science, Analytics
5 years’ related experience in clinical research. Equivalent combination of education, training and experience.
"Clinical/project management experience is preferred.;
Good knowledge of medical terminology, GCP, regulations, and Drug Development process.;
In-depth understanding of clinical research.;
Excellent communication, organizational and interpersonal skills.;
Business level of English.
Strong computer literacy, including well-developed computer skills in applicable software.
Ability to work independently and effectively prioritize tasks. more

Responsibilities:

Import data from various sources
Program quality control checks for source data and reporting data issues
Interpret project level requirements and develop programming specifications
Write programming code following established Good Programming Practices
Program SDTM and ADaM datasets
Program to create statistical analysis tables, listing and figures
Validate datasets and... all statistical outputs per prescribed gate checks
Communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and timelines
Use and promote the use of established standards, SOPs, and standard methodologies
Export data and clinical study report materials
Provide training and mentoring to team members and department staff

You can help us bring clinical trial statistical analysis into the next generation. Award winning and innovative, we will give you access to cutting-edge in-house technology, allowing you to work on global projects across therapeutic areas. Be challenged in a fast-paced team environment that is collaborative in performing biostatistical analyses and advanced statistical programming. Development opportunities and mentoring at all levels enable you to progress your long-term career in the direction you choose.
THE PERSON
We know that meaningful results require not only the right approach, but also the right people. Candidates should possess a Master’s or Bachelor’s degree in Biostatistics, Statistics, Mathematics, or Computer Science, and have a strong educational or practical evidence in programming.
Key required skills include:

Home Based/Remote
5+ experience in Statistical Programmer role from CRO/Pharma with ADaM/SDTM/ TLFs
Excellent accuracy, attention to detail, problem solving, organizational as well as interpersonal communication.
In light of the above, candidates for the roles should exhibit the following skills and competencies:
Experience in programming in SAS within the CRO/Pharma/Biotech/Healthcare industries
Knowledge of statistics and exhibit routine and occasionally complex analytical skills
A focus on quality, accuracy, and completeness of work activities 
Excellent communication skills
A good understanding of Good Clinical Practice and ICH guidelines
Ability to independently lead (or have lead potential) and estimate programming scope of work, handle resource assignments, communicate work status, and work within project timelines for deliverables
Take initiative and can be counted on to get the job done, with integrity
Have the self-awareness to recognize when negotiating skills and assistance are needed
Ability to establish and maintain effective working relationships with co-workers, managers, and clients more

Essential Functions

Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
Gain experience in study procedures by working with experienced clinical staff.
Under close supervision, perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices.
Under close... supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
Under close supervision, 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.
Under close supervision, 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 Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements.
Under close supervision may support start-up phase.
Under close supervision, 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, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas for improving site recruitment plan in line with project needs to enhance predictability. Assist in tracking subject site recruitment progress.

Qualifications

Bachelor's Degree Degree in scientific discipline or health care preferred. Req
Equivalent combination of education, training and experience may be accepted in lieu of degree.
Prior clinical experience preferred.
Some organizations may require 2 years of clinical experience.
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.
Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Knowledge of applicable protocol requirements as provided in company training. more

Drive proactive early engagement and customer management approach creating a pipeline of trial activity in Africa with a key focus on global public health engagements. Drive market shaping activities in the clinical trial ecosystem with key partners Provide operational specificity in proposals as an Africa operational SME to increase the number of studies Africa is included in Develop and manage... ongoing thought leadership and marketing activities May perform consulting work on GPH ecosystem activities externally Internally support all business-related reporting requirements

Work with senior leadership in formulating effective strategic goals and objectives for designated organization and assures operational alignment with organization priorities.

Essential Functions

Establish client and stakeholder relationships and partnerships to shape the clinical trial ecosystem
Collaborate with other regional and/or global clinical and client teams and other functional leadership to manage project related challenges and to achieve exemplary customer service.
Act as a client liaison in day-to-day relationship governance, escalations and other client-facing initiatives.
Participates in corporate or organizational quality or process improvement initiatives.
May manage other managers.

Qualifications

Bachelor's Degree Degree in scientific discipline or health care preferred. Req
At least 7 years prior clinical trial experience including experience in a management/leadership capacity or equivalent combination of education, training and experience.
Advanced knowledge of applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
Knowledge of clinical research financial parameters and project financial tracking and accounting methods.
Strong leadership skills.
Effective presentation skills.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
Written and verbal communication skills including good command of English.
Excellent organizational and problem solving skills.
Effective time management skills and ability to manage competing priorities.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients. more

Job Description

IQVIA is looking to appoint statistical programmers to utilize the SAS programming language to develop clinical study report materials according to the objectives of a clinical trial for regulatory submissions. Programming and performing related tasks serving the full spectrum of statistical programming needs in our DS3 environment (home based):

Responsibilities:

Import... data from various sources
Program quality control checks for source data and reporting data issues
Interpret project level requirements and develop programming specifications
Write programming code following established Good Programming Practices
Program SDTM and ADaM datasets
Program to create statistical analysis tables, listing and figures
Validate datasets and all statistical outputs per prescribed gate checks
Communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and timelines
Use and promote the use of established standards, SOPs, and standard methodologies
Export data and clinical study report materials
Provide training and mentoring to team members and department staff
You can help us bring clinical trial statistical analysis into the next generation. Award winning and innovative, we will give you access to cutting-edge in-house technology, allowing you to work on global projects across therapeutic areas. Be challenged in a fast-paced team environment that is collaborative in performing biostatistical analyses and advanced statistical programming. Development opportunities and mentoring at all levels enable you to progress your long-term career in the direction you choose.

THE PERSON

We know that meaningful results require not only the right approach, but also the right people. Candidates should possess a Master’s or Bachelor’s degree in Biostatistics, Statistics, Mathematics, or Computer Science, and have a strong educational or practical evidence in programming.

Key required skills include:

Home Based/Remote
5+ experience in Statistical Programmer role from CRO/Pharma with ADaM/SDTM/ TLFs
Excellent accuracy, attention to detail, problem solving, organizational as well as interpersonal communication.
In light of the above, candidates for the roles should exhibit the following skills and competencies:
Experience in programming in SAS within the CRO/Pharma/Biotech/Healthcare industries
Knowledge of statistics and exhibit routine and occasionally complex analytical skills
A focus on quality, accuracy, and completeness of work activities 
Excellent communication skills
A good understanding of Good Clinical Practice and ICH guidelines
Ability to independently lead (or have lead potential) and estimate programming scope of work, handle resource assignments, communicate work status, and work within project timelines for deliverables
Take initiative and can be counted on to get the job done, with integrity
Have the self-awareness to recognize when negotiating skills and assistance are needed
Ability to establish and maintain effective working relationships with co-workers, managers, and clients
Embrace your curiosity and grow your career in an exciting environment where development is a priority. Think boldly and disrupt conventional thinking. Enjoy what you do. Discover a career with greater purpose and help create a healthier world.

Whatever your career goals, we are here to ensure you get there!
This role is not eligible for UK visa sponsorship more

Provide administrative support to clinical projects under direction of line manager and/or other designated clinical team members. Assists with general administrative functions as required.

Responsibilities

Assist Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that... track site compliance and performance within project timelines.
Assist the clinical team in 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/iCRAs 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 and with required approval.
May perform assigned administrative tasks to support team members with clinical trial execution.

Experience

Less that than 2 years experience and student interns will be considered.

Knowledge

Requires basic job knowledge of systems and procedures obtained through prior work experience or education. more