Auftragsdetails

Detailed Description

The Study Start-Up Specialist is responsible for all SSU-related activities in the country/ region, on assigned studies, overseeing and leading SSU activities in collaboration with other clinical research stakeholders.

• Responsible for study start up activities from beginning to the close out of the study; this includes but is not limited to site feasibility, site identification, regulatory submissions, site activation, maintenance, and study close out.
• Responsible for conducting site identification and site feasibility as assigned.
• Responsible for the regulatory package submissions to the Institutional Review Board (IRB)/Ethics Committee (EC). Prepares ongoing submissions, amendments and periodic notifications required by IRB/EC and regulatory authorities as needed within the regional requirements.
• As needed, supports study team and preparation of the site, and/or country specific Informed Consent Form (ICF).
• Executes all start-up activities prior to site activation on assigned studies, according to standards and aligned with study/project requirements and timelines.
• Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.
• Partners with other study team members to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations.
• Responsible for supporting study budget and contracts negotiation in collaboration with Study team, and Legal Counsel as applicable.

Requirements

• Bachelor’s degree preferred. Persons without a formal degree who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration.
• 4 years of clinical research experience preferred specifically in study start up.
• Experience in managing and meeting agreed targets for assigned deliverables during the start-up phase of a project.
• Experience in working in eTMF, CTMS, EDC, DCT and overall systems that support conduct of clinical trials
• Proficiency in web-based systems and project management applications (e.g. Microsoft Office, SharePoint, etc.)
• Being able to follow and comply with assigned SOPs
• Knowledge of ICH-GCP and applicable regulatory agency regulations

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.