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Site Activation Partner II (FSP)Job ID 69842BR Germany - Any Region - Home Based
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.
- 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.
QualificationsSkills and Education
- School 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.
- 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.
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