Study Start up Specialist
Hobson Prior are recruiting for a Study Start Up Specialist to join a multinational healthcare company in Hertfordshire. This position is accountable for all SSU-related activities in the country/region, on assigned studies, overseeing and leading SSU activities in collaboration with other clinical research stakeholders.
- Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.
- Performs all start-up activities prior to site activation on assigned studies, according to the organisations standards and aligned with study/project requirements and timelines.
- Prepares country level Informed Consent Form 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.
- Partners with Clinical Study Managers and Clinical Study Specialists 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.
- 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, Six Monthly SUSAR Reports and Development Safety Update Reports (DSURs).
- In partnership with CSMs, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.
- Accountable for study budget and contracts negotiation in collaboration with Contracts Manager/Associate, as required and ensures compliance with Fair Market Value (FMV) in the country.
- Strong planning and organisation skills.
- Building Customer Loyalty - meets and exceeds internal or external customer expectations while cultivating relationships that secure commitment and trust.
- Excellent communication skills.
- Ability to develop and leverage relationships within and across work groups to achieve results.
- University Degree or equivalent, preferably in a medical/science-related field.
- Demonstrated knowledge and understanding of clinical trials and experience in managing projects.
- Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP).
- An understanding of the regulatory, ethics and contractual requirements for starting clinical trials in the relevant country.
- Previous line management experience/supervision of staff is preferred.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
£380 - £420 per day
Welwyn Garden City, Hertfordshire
Hobson Prior are currently working with a global pharmaceutical organisation who are seeking two Global Studies Manager (Oncology and I2ON)