Study Start-Up Specialist (50-100%)
Our client is a pioneer in Drug Discovery and Development. As a leading Pharmaceutical company, they work in a vast number of drug & therapeutic areas and are highly recognized internationally.
The Study Start-up Specialist is responsible for all Study Start-up related activities in the country/region, on assigned studies, overseeing and leading activities in collaboration with other clinical research stakeholders.
- Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures;
- Executes all start-up activities prior to site activation on assigned studies, according to the company standards and aligned with study/project requirements and timelines;
- Prepares country level Informed Consent Form (ICF) and obtains ethics committees’ and local regulatory authorities’ approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country;
- Maintains and analyses study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement;
- Providing guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations;
- Supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory/Quality department, as required;
- Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies, laws, via innovative approaches;
- Submits, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SUSAR), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs);
- In collaboration with Country Study Managers (CSM), identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required;
- Responsibility for the feasibility and the start-up of the studies, as well as during implementation for various operational aspects, including study relevant contacts with investigators, study nurses, ethics committees, Swiss medic, the global study team and div. Internal local Medical Affairs areas in cooperation with the regional and global study team;
- Maintains effective and ongoing communication with CSM; supports communication with local study teams and to sites as required;
- Works with global study team and CSM to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of non-productive sites and tracking of safety procedures;
- Responsible for the co-ordination and oversight of local affiliate study level audit/inspection audit action plan activities.
Qualifications and Experience:
- University Degree or Equivalent preferably in a medical/science-related field;
- At least 2 years work experience demonstrating knowledge and understanding of clinical trials, such as that obtained in a clinical trial monitor capacity, and experience managing projects;
- Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in Switzerland;
- Experience in study start-up activities would be an advantage;
- Good command of German and English is critical;
- Fluent French skills are a preference;
- Communicative, open, accurate and reliable;
- Strong organisation skills;
- Customer service orientated;
- Team Player;
- Open to new ideas and to question conventional thinking;
- Priorities workload and communicate proactively;
- Open-minded and flexibility;
- Relevant working/residency permit or Swiss/EU-Citizenship required.