Job Description:

Job Overview:

The Study Start-Up Country Specialist (SSUCS II) works in collaboration with project teams and in collaboration with the Study Start-up (SSU) Manager to perform key SSU tasks in their country, or countries, of expertise. These tasks may include study feasibility, facilitation of site contracts and budget negotiations between sites and CP, review of document translations, submission to the Regulatory Bodies (Competent Authority and Ethic Committee (IRB/IEC), and other study start up activities, as assigned by the SSU Manager or designee. The SSUCS II is responsible for the collection of essential regulatory documents from sites and preparation, completion and/or review of country related submission packages in accordance with ICH-GCP and all applicable regulations, laws, guidelines and ethical standards within specific timelines and quality standards. May coach, mentor or on-board junior Specialists.

Job Duties and Responsibilities:

• Independently provides country-level expertise and support to SSU team and project team.
• Assists the Legal team with the completion and distribution of Confidential Disclosure Agreements (CDAs), as well as providing intermediation, as necessary, to support the execution of CDAs with sites within their country of expertise.
• Builds relationships with sites and investigators within country of expertise.
• Participates in the identification and selection of sites and investigators, including national lead investigators, as necessary. May provide submission strategy based on practical previous experience.
• May facilitate the distribution and collection of Feasibility Questionnaires (FQs) to sites in assigned countries and follows up accordingly to ascertain interest and to meet study timelines.
• Responsible for distribution, collection and review of site essential documents either directly or through coordination with assigned CRAs in specific countries for both submission and Essential Document Release purposes.
• Creates, translates (as native speaker or sufficiently skilled in the local language(s) to translate/review translations), and reviews regulatory documents specific to applicable Regulatory Bodies’ submission requirements.
• Translates, reviews, drafts local language documents, as necessary to support the interaction with local Regulatory Bodies.
• Assists with the creation, translation, and review of regulatory documents for Clinical Trial Applications (CTA, or equivalent) and submissions or notifications to the Regulatory Bodies, as applicable.
• Responsible for the collection and maintenance of submission information of the applicable Regulatory Bodies, and similar information for the assigned countries.
• Under supervision may Quality Check (QC) submission dossier for Regulatory Bodies.
• Provides submission strategy based on practical previous experience.
• Performs submissions or notifications to the applicable Regulatory Bodies.
• May draft cover letters, review translations, provide summarized translations for Grounds for Non-Acceptance (GNA/Deficiencies), and communicate with the applicable Regulatory Bodies, as necessary.
• Independently is responsible for the adaptation of Country and/or Site Informed Consent Form (ICF).
• Responsible for review and negotiation of site study budget and serve as liaison between Legal department and sites.
• Perform timely and accurate data entry of SSU status and documents, regulatory documents and submission status of Country/Site information in applicable tracking system(s) and the TMF.
• May be assigned to coach, mentor or on-board new hires or junior Specialists.
• Contributes into functional improvement initiatives.
• Other duties as assigned by the SSU Manager, SSU & Regulatory Lead, Country Manager, Director of SSU, or designee per project-specific requirements.

Supervisory Responsibilities:

No supervisory responsibilities.

Job Requirements:

• Education
  • Bachelor’s graduate with a healthcare or life science degree or equivalent experience.
• Experience
  • Minimum 3 years of experience as SSU Specialist or study Regulatory Specialist position preferably in the CRO or pharma industry.
• Skills/Competencies
  • Strong written and verbal communication skills.
  • Native-level or equivalent fluency with local language sufficient to translate/review/draft local language documents, if applicable.
  • Strong interpersonal skills.
  • Comprehensive knowledge of ICH-GCP guidelines.
  • Proficiency in medical terminology.
  • Able to exercise judgment within defined procedures and practices and to determine appropriate action independently.
  • Attention to detail.
  • Problem-solving skills.
  • Ability to work in a matrix environment.
  • Strong time management and organizational skills.
  • Fluent in English and local country language.
• Capabilities
  • Has demonstrated experience in SSU activities and in preparation of Regulatory submission package to Regulatory Bodies in accordance to ICH-GCP guidelines and to country specific standards.
  • Adheres to study timelines, documents study challenges, document collection and communicates updates to SSU Manager and/or Project Manager (PM).
  • Proficient computer skills, including Microsoft Office.

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