Senior Study Start Up Specialist

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

ProPharma are looking for an experienced Study Start up Specialist to join the business and support in site contracting primarily across EU but with a view to support globally if required.

The Senior 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.

Duties:

• 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.

Experience required:

• Bachelors qualification with appropriate education and clinical experience
• 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

This role can be completed remotely across Croatia, Slovenia, Bosnia and Herzegovina, Serbia, Montenegro, North Macedonia, Romania, Bulgaria, Georgia, Poland or Albania in line with ProPharma offices.