Site Activation Partner/Study Start Up Specialist - Fsp (Sevilla)

Site Activation Partner/Study Start Up Specialist - Fsp (Sevilla)

03 oct
|
Parexel
|
Sevilla

03 oct

Parexel

Sevilla

The 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 sponsor standards. Other duties to include but not limited to:Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiationProvide support to resolve issues or concerns and timely escalation of Site issues where applicableManage and coordinate with other supporting roles to ensure timely site activation and operational activitiesCollaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics)



are requiredAccurately update and maintain clinical trial systems that track site compliance and performance within project timelinesIdentify and resolve investigator site issuesExperience required for this role:School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferredMinimum 2 years relevant experience in Clinical Trials environment and clinical site activation.Experience working in the pharmaceutical industry/or CRO is an assetKnowledge of clinical trial methodologies, ICH/GCP, FDA and General and local country regulationsMust be fluent in Local language and in English. Multi-language capability is an asset#LI-LO1#LI-REMOTEEEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.#J-18808-Ljbffr

📌 Site Activation Partner/Study Start Up Specialist - Fsp (Sevilla)
🏢 Parexel
📍 Sevilla

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