Urwah Admin

ICON plc

<div>Manager Clinical Data Science, Trivandrum, India<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;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</div><div></div><div>
We are currently seeking a Manager, Clinical Data Science to join our diverse and dynamic team. As a Manager, Clinical Data Science at ICON, you will play a pivotal role in overseeing the analysis and interpretation of clinical data to support drug development and improve patient outcomes. You will contribute to the advancement of innovative treatments through strategic leadership in data management and analytics, ensuring the highest standards of quality and compliance in clinical research.</div><div>
What You Will Be Doing:</div><div></div><ul><li>
Driving the analysis of clinical trial data to derive actionable insights and support decision-making processes.</li><li>
Collaborating with cross-functional teams to ensure effective data collection, management, and reporting throughout clinical trials.</li><li>
Overseeing the implementation of best practices in data science methodologies and technologies within the organization.</li><li>
Providing mentorship and guidance to junior data scientists, fostering a culture of continuous improvement.</li><li>
Establishing strong partnerships with internal and external stakeholders to enhance data integrity and optimize clinical outcomes.</li></ul><div>
Your Profile:</div><div></div><ul><li>
Advanced degree in a relevant field such as biostatistics, data science, or a related discipline.</li><li>
Extensive experience in clinical data analysis, with a solid understanding of regulatory requirements and industry standards.</li><li>
Strong leadership skills with the ability to inspire and manage teams effectively in a collaborative environment.</li><li>
Proficiency in statistical software and programming languages, with a keen ability to translate complex data into clear insights.</li><li>
Excellent communication and interpersonal skills, with a track record of influencing stakeholders and driving positive change.</li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Manager Clinical Data Science

<div>Lead Clinical Data Science Programmer - Bangalore, India [6 Months Contract]<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;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</div><div></div><div>
We are currently seeking a Lead Clinical Data Science Programmer to join our diverse and dynamic team. As a Lead Clinical Data Science Programmer at ICON, you will play a key role in designing and developing clinical data solutions, ensuring the efficient handling, analysis, and reporting of complex clinical trial data. You will collaborate with cross-functional teams to drive data-driven insights that support the advancement of cutting-edge therapies and innovative clinical research.</div><div></div><div>
What You Will Be Doing</div><ul><li>
Serve as the primary point of contact for system programming during study setup, collaborating with cross-functional teams.</li><li>
Translate clinical study reporting needs into specifications and develop custom data review solutions using tools like JReview, Spotfire, and SAS.</li><li>
Build and maintain global standard reports integrating CRF, biomarker, and eCOA data.</li><li>
Design and implement advanced SQL queries, stored procedures, and visual analytics dashboards.</li><li>
Contribute to SOPs, working procedures, and internal documentation to support functional excellence.</li><li>
Support metadata management and MDR system updates.</li><li>
Deliver role-based training and generate compliance and metrics reports to support clinical operations.</li><li>
Identify and mitigate project risks, ensuring high-quality deliverables and timely communication with stakeholders.</li></ul><div>
Profile Expectations</div><ul><li>
Strong understanding of the end-to-end drug development process and FDA/ICH/GCP guidelines.</li><li>
Proven experience in clinical data reporting and analytics, with proficiency in SQL; knowledge of SAS, R, Python, and visualization tools is a plus.</li><li>
Excellent communication and organizational skills in a matrixed, cross-functional environment.</li><li>
Experience with EDC systems (Rave) and familiarity with computerized systems regulations in clinical trials.</li><li>
Ability to work independently, manage multiple priorities, and deliver high-quality outputs under tight timelines.</li><li>
Strong analytical mindset with a proactive approach to problem-solving and innovation.</li><li>
Experience in stakeholder engagement, requirement gathering, and translating business needs into technical solutions.</li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Lead Clinical Data Science Programmer

<div>Clinical Scientist<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;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</div><div></div><div>
We are currently seeking a Clinical Scientist to join our diverse and dynamic team. As a Clinical Scientist at ICON, you will play a critical role in designing and conducting clinical studies that advance our understanding of new therapies. You will contribute to the development of innovative treatments by applying scientific expertise and collaborating with multidisciplinary teams throughout the research process.</div><div></div><div>
What You Will Be Doing:</div><ul><li><div>
Designing and implementing clinical trial protocols, ensuring adherence to scientific and regulatory standards.</div></li><li><div>
Conducting data analysis and interpretation to derive insights that support study objectives.</div></li><li><div>
Collaborating with cross-functional teams to ensure effective study execution and data quality.</div></li><li><div>
Engaging with stakeholders to communicate findings and contribute to scientific discussions.</div></li><li><div>
Assisting in the preparation of regulatory submissions, study reports, and scientific publications.</div></li></ul><div></div><div>
Your Profile:</div><ul><li><div>
Advanced degree in life sciences, medicine, or a related field highly preferred.</div></li><li><div>
Experience in clinical research or a related scientific role, with a strong understanding of clinical trial processes.</div></li><li><div>
Excellent analytical skills and proficiency in data interpretation and statistical analysis.</div></li><li><div>
Strong communication and collaboration skills, with the ability to work effectively in interdisciplinary teams.</div></li><li><div>
Detail-oriented and committed to maintaining high standards of data integrity and quality.</div></li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Clinical Scientist

<div>Clinical Drug Supply Manager<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;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</div><div></div><div>
Supply Planning</div><ul><li><div>
Serves as lead logistics manager for the functional area in supply planning, including demand forecasting according to IOPS requirements; Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan; Works with clinical logistics management to determine resourcing needs; Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals; Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines; Oversees setup and management of IVRS (IWRS)</div></li></ul><div>
Inventory tracking</div><ul><li><div>
Manages and tracks investigational product (IP) inventory; advises supply management team of potential shortages and makes recommendations for resupply activities based on usage trends.</div></li></ul><div>
Shipments</div><ul><li><div>
Oversees IP shipment orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely and compliant shipment and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity and/or manages any/all aspects of the process.</div></li></ul><div>
IVRS</div><ul><li><div>
Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS; Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors. Lead effort for clinical supply management functionality; Monitor and manage clinical supply activities through IRT from study start-up through study closure; Ensure appropriate system documentation is transferred for TMF and inspection readiness.</div></li></ul><div></div><div>
Temperature excursions</div><ul><li><div>
Reviews and evaluates temperature excursion data and communicates stability information to clinical trial managers, CROs, and investigator sites; provides assessments to supply management team regarding excursion trends in each study.</div></li></ul><div>
Returns &amp; Destruction</div><ul><li><div>
Reviews drug return and destruction records; communicates with investigator sites, CROs and external vendors to resolve issues.</div></li><li><div>
Authorizes final destruction of drug returns to 3rd party vendor.</div></li></ul><div>
Expiry Management</div><ul><li><div>
Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.</div></li></ul><div>
Ancillary Supplies</div><ul><li><div>
Develop plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors.</div></li></ul><div>
Documentation</div><ul><li><div>
Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File. Provides input to drug kit randomization specifications and reviews and master kit lists; Reviews IVRS specs and reviews IVRS user manuals; Designs, reviews and approves IP-related study tools (for clinical study teams and investigative site use), as needed. Supports inspection team in preparation for and during regulatory agency inspection.</div></li></ul><div>
Study Team Interaction</div><ul><li><div>
Represents Clinical Logistics/Supply Management on cross-functional study team (s) and/or sub-team(s); Provides input into budgets, SoWs, contracts and timelines for IP-related services; Prepares or provides input into IP-related content for training materials and coordinates training on study procedures; In collaboration with the CTM for study, provides input into IP-related study specific working practices; Establishes study team contacts, roles, responsibilities, and objectives for IP-related services; Develops, manages, and maintains relationships with external partners; Effectively communicates with CROs, shipping and IVRS vendors, study sites and study team members to ensure ongoing successful execution; Acts as point of escalation for IP-related issues.</div></li><li><div>
This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, therapeutic area project managers, medical monitors, as well as staff from quality, clinical compliance, regulatory, formulations, and IOPS (CMC, external manufacturing, stability).</div></li></ul><div>
Vendor Management</div><ul><li><div>
Leads management of IP service vendors (performance, quality, timelines, deliverables, costs); Participates in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS); Provides input, reviews, and approves vendor study specifications; Serves as point of escalation for vendor-related IP issues as they arise; Reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated; Recommends vendors to IOPS and Clinical Study Teams.</div></li></ul><div>
Staff Management</div><ul><li><div>
Does not supervise staff.</div></li><li><div>
May mentor or coach junior Clinical Logistics staff.</div></li></ul><div>
Process Initiatives</div><ul><li><div>
Develop and implement process initiatives in accordance with business needs.</div></li><li><div>
Contributes to ongoing process improvement initiatives.</div></li></ul><div>
Metrics</div><ul><li><div>
Track metrics related to drug supply processes and staff.</div></li></ul><div>
Training</div><ul><li><div>
Provide assistance in training and development as needed.</div></li></ul><div></div><div>
Reporting</div><ul><li><div>
Compiles and reports supply status to study teams and senior management</div></li></ul><div>
Problem solving</div><ul><li><div>
Applies knowledge of company policies and standard practices to resolve problems.</div></li></ul><div></div><div>
Requirements</div><div></div><ul><li><div>
Bachelor&rsquo;s degree Required. Health Sciences/Biological field preferred</div></li><li><div>
At least 5 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum managing clinical supply in the clinical research setting</div></li><li><div>
Experience managing the distribution strategy plan for clinical trials required</div></li><li><div>
Experience with forecasting IP supply in clinical trials required</div></li><li><div>
Experience utilizing Excel or working within an ERP system or both required</div></li><li><div>
Experience working with Third party depots required</div></li><li><div>
Experience working with and sourcing comparators in clinical trials preferred</div></li><li><div>
Experience creating or contributing to development of Pharmacy manuals preferred</div></li><li><div>
Oncology therapeutic area experience is preferred</div></li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Clinical Drug Supply Manager

<div>Clinical Data Quality Associate - onsite - entry level<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;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</div><div></div><div>
We are currently seeking a Clinical Data Quality Associate to join our diverse and dynamic team. As a Clinical Data Quality Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies.</div>
What you will be doing<ul><li>
Conduct quality control checks on clinical trial data to ensure accuracy, completeness, and consistency.</li></ul><ul><li>
Collaborate with data management teams to identify and resolve data discrepancies and aNmalies.</li></ul><ul><li>
Assist in the development and implementation of data quality processes and procedures to maintain high standards throughout the data lifecycle.</li></ul><ul><li>
Perform data review and validation activities according to established protocols and regulatory requirements.</li></ul><ul><li>
Generate reports and documentation to track data quality metrics and identify areas for improvement.</li></ul><div></div>
Your profile<ul><li>
Bachelor's degree in a relevant scientific discipline or equivalent experience.</li></ul><ul><li>
Previous experience in clinical data management or data quality assurance within the pharmaceutical, biotechNlogy, or CRO industry.</li></ul><ul><li>
Familiarity with CDISC standards, FDA/EMA regulations, and ICH-GCP guidelines.</li></ul><ul><li>
Strong attention to detail and analytical skills, with the ability to identify and resolve data discrepancies.</li></ul><ul><li>
Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.</li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Clinical Data Quality Associate - onsite - entry level

<div>CDC I - Bangalore India<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;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</div><div></div><div>
We are currently seeking a Clinical Data Coordinator I to join our diverse and dynamic team. As a Clinical Data Coordinator at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.</div><div>
What you will be doing</div><ul><li>
Assist Data Management Study Lead in development of eCRF, Data Validation Specifications, and Study Specific Procedures.</li></ul><ul><li>
Review clinical and third-party data based on edit specifications and data review plans.</li></ul><ul><li>
Issue clear, accurate, and concise queries to investigational sites.</li></ul><ul><li>
As required, communicate effectively with peers, clinical data scientist and functional management.</li></ul><ul><li>
Perform other project activities as required in order to ensure that study timelines are met (for example, filing and archiving of study documentation, dispatching of queries to investigator sites for resolution, etc.).</li></ul><div></div><div>
Your profile</div><ul><li>
Bachelor's degree in a relevant field, such as Life Sciences or Healthcare.</li><li>
1.5 years of experience in Data Management activities - including Data review, query management, database design, TMF documentation, and implementation of clinical data tools using EDC systems. (Mandatory)</li><li>
Hands-on experience in data management software and systems (e.g., Medidata, Oracle RDC, or similar)</li><li>
Strong attention to detail and the ability to work effectively in a fast-paced environment.</li><li>
Excellent communication skills and the ability to collaborate with cross-functional teams.</li><li>
Knowledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus.</li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

CDC I

<div>Site Specialist II, Study Start Up<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;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</div><div></div><div>
We are currently seeking a Site Specialist II (Study Start Up Associate II) to join our diverse and dynamic team. As a Site Specialist II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.</div><div></div><div>
What you will be doing</div><ul><li><div>
Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.</div></li></ul><ul><li><div>
Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.</div></li></ul><ul><li><div>
Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence</div></li></ul><ul><li><div>
Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.</div></li></ul><ul><li><div>
Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.</div></li></ul><div></div><div>
Your profile</div><ul><li><div>
Bachelor's degree in life sciences or a related field.</div></li></ul><ul><li><div>
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.</div></li></ul><ul><li><div>
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.</div></li></ul><ul><li><div>
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.</div></li></ul><ul><li><div>
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.</div></li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Site Specialist II, Study Start Up

Join ICON plc and explore 9   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.