Job Description

About the jobThe 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 within a country and may span over more than one country depending on the geographical region and business needs.Role ResponsibilitiesClinical Trial Site ActivationInitiate 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 initiationProvide support to resolve issues or concerns and timely escalation of Site issues where applicablePrepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelinesManage 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 requirementsCoordinate 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 approvalAssist 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 roleClinical Trials ConductPost site activation, initiate and coordinate activities and essential documents management with the investigators 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 conductEnsure maintenance of IRB/Ethics and other committees activities as applicableResponsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completenessAccurately update and maintain clinical trial systems that track site compliance and performance within project timelinesSupports investigator sites, and study teams in preparation for and providing responses to site audits / inspectionsInternal External CommunicationMaintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requestsProvide functional updates on a country and site level as requiredEstablish tools for efficient updates to study team as needed regarding site status, issues, delays, approvalsDisseminate Central or Local Ethics Approval to study team and Investigator Sites where applicableCommunicate Local sites approvals to study team members and stakeholdersClinical Trial Site SupportAs needed, perform, awareness session with site personnel on Pfizer requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Pfizer standardsIdentify 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 issuesAdditional Responsibilities:A good understanding of the Site Activation requirements and processes within the country/region and be able to learn and potentially implement in more than one (1) countryMay be assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multi-countryMay be assigned as an SME on a system and/or process, and represent the SAP function as applicableMay represent the SAP role on global initiativesAble to act as an SME on projects and initiatives, as requestedSupport the mentoring of new hires on processes/ systemsSystems ToolsAbility to use and learn systems, and to use independentlyMicrosoft SuiteClinical Trial Management Systems (CTMS)Electronic Trial Master FileElectronic Investigator Site File (e.g. Florence)Document exchange portalsShared Investigator PlatformEthics, National Networks and Governing Bodies Portals and platforms (as needed)Qualifications / SkillsBASIC QUALIFICATIONSBS/BA or bachelors degree in Life Sciences preferred2-6 years relevant experience in Clinical Site Management.Experience working in the pharmaceutical industry/or CRO in study site activation is an assetKnowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulationsMust be fluent in Local language and in English. Multilanguage capability is an assetFor individuals based in Canada: Bilingualism (French, English) is an assetEffective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organizationGood technical skills and ability to learn and use multiple systemsPhysical/Mental RequirementsDemonstrated knowledge of clinical research and development processes, Key operational elements of a clinical trial, and ability to gain command of process detailsUnderstand the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company, regulatory and country requirements. Attention to detail evident in a disciplined approachAbility to work independently and also as a team memberAbility to organize tasks, time and priorities, ability to multi-taskUnderstand basic medical terminology, GCP requirements and proficient in computer operationsORGANIZATIONAL RELATIONSHIPSGlobal Study Manager and Start-Up Project Manager, Global Study ClinicianLocal Site Relationship Partners and Director Clinical Site Operations, Clinical Trials Manager and other Local RolesGlobal Investigator Initiation Package (IIP) Regulatory GroupLocal Regulatory Manager, CTA Hub and CTA Submission ManagersSite Intelligence TeamContract specialistsInvestigators SitesCountry Ethics Committee representativesOther governing bodies representativesLocal provincial/States and national networksLifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.Please use the below Lifelancer link for job application and quicker response.

Lifelancer