Site Activation Partner I - Spain - FSP
When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.External Job DescriptionIf you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at Site Activation Partner, home-based and sponsor dedicated, in Spain.In this role you will be responsible for leading or supporting operational activities from startup 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 Client standardsWe are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success.As the company that conducts vital clinical studies for sponsors, including the world's leading biotechâs and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects.You will work from your home office base, supporting studies within their country or region. âManageable sites, manageable protocolsâ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.Primary Responsibilities:Clinical Trial Site Activation
Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation
Register investigator sites and Client stakeholders in Client registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready
Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in Shared Investigator Platform (SIP) or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status
Take the lead 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
Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements
Coordinate the timely communication, documentation and responses between Client and Central Ethics committee to bring clinical study to approval (country dependent)
Support investigators sites with local IRB workflow from preparation, submission through approval
Clinical Trials Conduct
Post site activation, initiate and coordinate activities and essential documents management with the investigatorâs 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 maintenance of IRB/Ethics and other committeesâ activities as applicable
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
Attend study Start-up meeting and provide functional updates on a country and site level
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 session with site personnel on Client requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Client 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
From you we expectSchool diploma/certificate with equivalent combination of education, training and experience; Bachelor of Science, Bachelor of Arts or Bachelorâs in Life Sciences preferred
Minimum 2 yearsâ relevant experience in clinical site management and site activation.
Experience working in the pharmaceutical industry/or CRO in study site activation.
Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations.
Good technical skills and ability to learn and use multiple systems.
Demonstrated knowledge of clinical research and development processes, Key operational elements of a clinical trial, and ability to gain command of process details.
Must be fluent in Local language and in English.
For an immediate interview, please contact [email protected] posted on Himalayas
Apply Now
Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation
Register investigator sites and Client stakeholders in Client registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready
Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in Shared Investigator Platform (SIP) or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status
Take the lead 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
Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements
Coordinate the timely communication, documentation and responses between Client and Central Ethics committee to bring clinical study to approval (country dependent)
Support investigators sites with local IRB workflow from preparation, submission through approval
Clinical Trials Conduct
Post site activation, initiate and coordinate activities and essential documents management with the investigatorâs 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 maintenance of IRB/Ethics and other committeesâ activities as applicable
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
Attend study Start-up meeting and provide functional updates on a country and site level
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 session with site personnel on Client requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Client 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
From you we expectSchool diploma/certificate with equivalent combination of education, training and experience; Bachelor of Science, Bachelor of Arts or Bachelorâs in Life Sciences preferred
Minimum 2 yearsâ relevant experience in clinical site management and site activation.
Experience working in the pharmaceutical industry/or CRO in study site activation.
Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations.
Good technical skills and ability to learn and use multiple systems.
Demonstrated knowledge of clinical research and development processes, Key operational elements of a clinical trial, and ability to gain command of process details.
Must be fluent in Local language and in English.
For an immediate interview, please contact [email protected] posted on Himalayas
Apply Now