Site Activation Partner II - QAG846

Site Activation Partner II - QAG846

23 sep
|
Parexel International Corporation
|
Buenos Aires

23 sep

Parexel International Corporation

Buenos Aires

 The Site Activation Partner II (SAP II) 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 Client



standards.



 Responsibility span within a country or multi-country depending on the geographical region and



business needs.



Reports to the ExecuPharm (EP) assigned Line Management with day-to-day direction from Client.



Refer to Organizational Chart for details regarding assigned role and associated reporting structure



 Partners with Global Site and Study Operations (GSSO), Clinical Development and Operations



(CD&O;),

Regulatory Affairs, Pharmaceutical Sciences, Medical Quality Assurance, Legal, and Drug



Safety Unit



Clinical Trial Site Activation & Conduct



 Initiate and coordinate activities and essential documents management towards the compilation of



a high-quality Investigator Initiation Package (IIP) leading to sites initiation approval



 Register investigator sites 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 complete critical information and readiness for



site activation; inclusive of but not limited to IIP essential documents components, study contracts



contacts, clinical supply shipment information, payment information, Investigator Review Board



(IRB) submission and status



 Take the lead to resolve issues or concerns and timely escalation of issues where applicable



 Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms,



Food and Drug Administration (FDA) 1572 revisions, for internal regulatory approval within required



timelines



 Lead a subset and assist with the overall site activation process and coordinate operational



activities to ensure timely site activation



 Take the Lead and Coordinates the compilation of the Central IRB package and submissions to



approval of the study



 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



 Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of



tracking information as needed



 Initiate and coordinate activities and essential documents management with the investigator’s sites



(post site initiation visit (SIV)) during study conduct 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 revisions, Ethics Committee annual approvals



 Responsible for timely filing of documents to Trial Master File and other systems and assist with



periodic quality review of study files for accuracy and completeness QualificationsSchool diploma/certificate with equivalent combination of education, training and experience;



BS/BA or bachelor’s degree in life sciences preferred



 Minimum 6 years relevant 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



 Must be fluent in Local language and in English.



 For individuals based in Canada: Bilingualism (French, English) is an asset



 Effective verbal and written communication skills in relating to colleagues and associates both



inside and outside of the organization



 Good technical skills and ability to learn and use multiple systems



 Experience working in a global environment



 Experience in working in more than 1 country is an asset



 Demonstrated knowledge and understanding of key operational elements of a clinical trial and



processes (e.g., study start-up, conduct, close-out activities, reporting, etc.) and ability to gain



command of these processes



 Understand 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 approach



 Proven ability to work independently and also as a team member



 Ability to organize tasks, time and priorities, ability to multi-task



 Understand basic medical terminology, GCP requirements and proficient in computer



operations.





2021-09-23 00:05:57

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