Sr Study Sturt-up Specialist
Norway, 3 days at office
• Independently manages multiple country, study and site level deliverables during start-up and maintenance both within Sponsor and external business partners and vendors, when required.
• Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones
• Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents
• Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
• Prepare and perform submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission).
• Collaborates with other internal roles in country feasibility and site selection.
• Serves as an SME for key investigational sites. Documents and maintains relevant information on the site’s structure, start-up processes, key contacts for sharing with internal team members.
• Represents the Sponsor in local (e.g. pharma association or HA driven) working groups around start up processes in the country
• Represents the Sponsor in meetings discussing local requirements / repetitive questions from local Health Authority and Ethics Committees
• Proactively works with stakeholders (e.g. document template owners) to prevent questions from HA based on observed past questions.
• Constantly analyse the SSU process, looking for innovative ways to introduce efficiencies in order to speed-up start-up timelines, whilst maintaining quality.
The ideal candidate will need the following experience / skills to be considered:
• Bachelors or Masters Degree within life sciences or equivalent
• 5 years or more of industry related experience that includes significant experience in coordination of trial start-up activities and support to Health Authority / Ethic Committee submissions
• Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
• Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
• In depth knowledge and understanding of clinical research processes, regulations and methodology
• Demonstrated organizational and planning skills and independent decision-making ability
• Strong organization and time management skills and ability to effectively manage multiple competing priorities
• Ability of critical thinking and risk analysis.
• Good verbal and written communication skills (both in English and local language).