ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards. Responsibility span within a country or multi-country depending on the geographical region and business needs
Clinical Trial Site Activation
- Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation
- Provide support to resolve issues or concerns and timely escalation of Site issues where applicable
- Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
- Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
- Take the Lead, initiate and coordinates activities related to compilation of high-quality IRB/EC package and ensure timely submission to approval (Central and or Local and in countries where applicable), and other committees as per country requirements
- Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required
- Coordinate the timely communication, documentation and responses between Pfizer and Central Ethics committee to bring clinical study to approval (country dependent)
- Support investigators sites with local IRB workflow from preparation, submission through approval
- Lead or assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures.
- Support & implement activities in Shared Investigator Platform to align with Pfizer strategy as it relates to the role
Clinical Trials Conduct
- Post site activation, initiate and coordinate activities and essential documents management with the investigator’s sites towards the compilation of a high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, Ethics Committee annual approvals and other activities required during study conduct
- Ensure continuation of IRB/Ethic’s and other committees activities Post SIV, and related submission, notifications, reapprovals etc..
- Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness
- Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
- Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections
Internal & External Communication
- Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests
- Provide functional updates on a country and site level as required
- Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals
- Disseminate Central or Local Ethics Approval to study team and Investigator Sites where applicable
- Communicate Local sites approvals to study team members and stakeholders
Clinical Trial Site Support
- As needed, perform awareness sessions on Pfizer requirements with site personnel to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards
- Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues
Additional Responsibilities:
- Deep understanding of the Site Activation requirements and processes within the country and be able to develop and implement in more than one (1) country to enable multi-country coverage.
- Assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multi-country:
- Represent the SAP role on the study
- Take the lead in the compilation and preparation of the Investigator Initiation Package (IIP) Template for the study and share with SAP team globally
- Communicate with SAPs globally on study information and timelines
- Be an SME on one or more system and/or process, be the go-to person and train the SAPs on these respective systems or processes
- Represent the SAP role on global initiatives
- Able to act as an SME on projects and initiatives, as requested
- Mentor for new hires on processes, systems and SAP activities facilitating and optimizing the time from hire/training to assignment on a study
- Able to manage a high volume of, complex studies and sites
Systems & Tools
Ability to use and learn systems, and to use independently
- Ethics, National Networks and Governing Bodies Portals and platforms
- Electronic Investigator Site File (e.g. Florence)
- Microsoft Suite
- Clinical Trial Management Systems (CTMS)
- Electronic Trial Master File
- Document exchange portals
- Shared Investigator Platform
- Bachelor’s degree in life sciences is preferred
- Solid experience in Clinical Trials environment and clinical site activation. Experience working in the pharmaceutical industry/or CRO is an asset
- Demonstrated deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations, specially US
- Must be fluent in Local language and in English.
- Multilingual capability is an asset
- Effective verbal and written communication skills relating to colleagues and associates both inside and outside of the organization
- Good technical skills and ability to learn and use multiple systems
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
