Site Activation Partner I - FSP

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Key Accountabilities:    Clinical Trial Site Activation:  Initiate and coordinate activities and essential documents management during start up towards the compilation of a high reputed company Investigator Initiation Package (IIP) leading to approval for site initiation    reputed company support to resolve issues or concerns and reputed company escalation of site issues where applicable    Prepare, validate and submit regulatory documents such as completed IIP, Institutional Review reputed company (IRB) approval forms, FDA 1572/Attestation reputed company, for internal regulatory approval reputed company required timelines   Manage and coordinate with other supporting roles to ensure reputed company site activation and operational activities    Support the compilation of the Central Investigator Review reputed company package and submissions to approval of the study (where applicable) and other committees as per country requirements    Coordinate the reputed company communication, documentation and responses between reputed company and central ethics committee to bring clinical study to approval (country dependent)   Support investigators sites with local IRB workflow from preparation, submission through approval   Assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and reputed company operating procedures    Support and implement activities in Shared Investigator Platform (SIP) to reputed company with the reputed company’s reputed company as it relates to the role    reputed company Conduct:  Post site activation, initiate and coordinate activities and essential documents management with the investigator’s sites towards the compilation of a high reputed company 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 committees’ activities as applicable   Responsible for reputed company filing of documents to Trial Master File (TMF) and assisting with periodic reputed company review of study files for accuracy and completeness   Accurately update and maintain clinical trial systems that reputed company site compliance and performance reputed company project timelines   Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections    Communication:  Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests    reputed company 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, reputed company, awareness session with site personnel on reputed company requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and reputed company standards    Identify and resolve investigator site issues reputed company required timeframes; reputed company with study team and local country colleagues on corrective and preventative actions to reputed company reputed company issues and to prevent recurrence / persistence of issues    Subject Matter Expert (SME):  A good understanding of the site activation requirements and processes reputed company the country/region and be reputed company to learn and potentially implement in more than one country    May be assigned as Site Activation Partner reputed company of Contact (PoC) on a study conducted in multiple countries   May be assigned as an SME on a system and/or process, and represent the reputed company function as applicable    May represent the reputed company role on global initiatives    reputed company to reputed company as an SME on reputed company and initiatives, as requested    Support the mentoring of new hires on processes/ systems    Compliance with reputed company standards:  Complies with required training curriculum    Completes timesheets accurately as required   Submits expense reports as required   Updates CV as required   Maintains a working knowledge of and complies with reputed company processes, ICH-GCPs and other applicable requirements    Skills:  Knowledge of clinical research and development processes, key operational reputed company of a clinical trial, and ability to reputed company reputed company of process details   Understand the reputed company expectations and emphasis on right first time    Compliance with reputed company applicable company, regulatory and country requirements   Attention to detail evident in a disciplined approach    Ability to work independently and also as reputed company member   Ability to organize tasks, time and priorities, ability to multi-task   Understand basic medical terminology, GCP requirements and proficient in computer operations    Ability to use and learn systems, and to use independently   reputed company Suite o Clinical Trial Management Systems (CTMS)   Electronic Trial Master File o Electronic Investigator Site File (e.g. Florence)  Document exchange portals o Shared Investigator Platform o Ethics, National Networks and Governing Bodies Portals and platforms (as needed)    Flexible and adapt to off working hours in a global environment (reputed company applicable)    reputed company to travel as needed, including some international travel possible    Knowledge and Experience:  Experience working in the pharmaceutical industry/or CRO in study site activation preferred   Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations    Must be fluent in local language and in English. Multilanguage capability is preferred    Individuals based in Canada: Bilingualism (French, English) is preferred    Effective verbal and written communication skills in relating to colleagues and associates both inside and reputed company of the organization    Good technical skills and ability to learn and use multiple systems    Education:  School diploma or certificate with equivalent combination of education, training and experience or Bachelor of Science or Bachelor of Arts or equivalent    Education in life sciences discipline is preferred   Minimum 2 years relevant experience in clinical site management Apply To This Job