Site Activation Partner - 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.Key Accountabilities:Clinical 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, Institutional Review Board (IRB) approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelineManage and coordinate with other supporting roles to ensure timely site activation and operational activitiesSupport the compilation of the Central Investigator Review Board package and submissions to approval of the study (where applicable) and other committees as per country requirementsCoordinate 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 approvalAssist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating proceduresClinical Trials ConductPost 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 conductEnsure maintenance of IRB/Ethics and other committees’ activities as applicableResponsible for timely filing of documents to Trial Master File (TMF) 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 / inspectionsCommunicationMaintain 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 client requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and client 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 issuesSubject Matter Expert (SME)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 countryMay be assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multiple countriesMay 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/ systemsSkills: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 timeCompliance with all applicable company, regulatory and country requirementsAttention 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 operationsAbility to use and learn systems, and to use independentlyo Microsoft Suiteo Clinical Trial Management Systems (CTMS)o Electronic Trial Master Fileo Electronic Investigator Site File (e.g. Florence)o Document exchange portalso Shared Investigator Platformo Ethics, National Networks and Governing Bodies Portals and platforms (as needed)Flexible and adapt to off working hours in a global environment (when applicable)Able to travel as needed, including some international travel possibleKnowledge and Experience:Experience working in the pharmaceutical industry/or CRO in study site activation preferredKnowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulationsMust be fluent in local language and in English. Multilanguage capability is preferredEffective 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 systemsEducation:School diploma or certificate with equivalent combination of education, training and experience orBachelor of Science or Bachelor of Arts or equivalentEducation in life sciences discipline is preferredMinimum 2 years relevant experience in clinical site managementOriginally posted on Himalayas

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