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 experience study start up professional to join our growing business & help on newly awarded work. To be successful in this role you have experience leading study start ups for a minimum of 5 years.
The Senior Study Start Up Lead position is responsible for all SSU-related activities in the country/region, on assigned studies, overseeing and leading SSU activities and/or SSU teams in collaboration with other clinical research stakeholders.
Essential Functions:
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Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.
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Manages both the technical and operational aspects of site identification, site feasibility and site activation for assigned projects, site contracts, and project teams.
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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.
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Executes all start-up activities prior to site activation on assigned studies, according to standards and aligned with study/project requirements and timelines.
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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.
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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.
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Supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory /Quality department, as required.
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In collaboration with Clinical Site Manager, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.
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Responsible for study budget and contracts negotiation in collaboration with Legal team, as required and ensures compliance with Fair Market Value (FMV) in the country.
Skills and experience required:
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5+ years’ experience within a Clinical Research, Site Activation, and Study Start Up.
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Must be able to prioritize and manage multiple projects and show attention to detail.
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Comprehensive knowledge and understanding of ICH-GCP
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Working knowledge and experience in Microsoft Office (e.g., Word, Excel, Project)
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Experience with working in eTMF and CTMS within the framework of the study start up responsibilities.
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Bachelor’s degree required, preferably in life sciences, or related fields- Persons without a formal degree who have comparable rable depth and breadth of training and experience and who meet job-specific criteria will also be considered.
This is a remote role across ProPharma entities- United Kingdom, Netherlands, Germany, Sweden, Serbia, Croatia & North Macedonia
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.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
