Overview
In this role you lead or support global, mostly low-complexity studies as part of a cross-functional team, contributing medical expertise to protocol development and regulatory submissions. You drive study execution strategies, site selection, and risk management, while coordinating with stakeholders to ensure timely, high-quality data. You will interpret trial data, support CSRs and publications, and participate in dose-escalation meetings to inform decisions. This position offers impact across early development and study optimization within a collaborative, cross-functional environment.
Verantwortungsbereiche
- Serve as Study Leader or Clinical Scientist for global studies and provide support for high-complexity studies when needed
- Lead or support protocol development with Medical Lead and cross-functional teams
- Author clinical protocols, amendments, and study documents
- Contribute medical/scientific input to study documents, processes, regulatory submissions
- Support strategic input into study concepts, feasibility, and execution strategies
- Develop and implement study-level operational execution plans with cross-functional partners
- Identify, evaluate, and select high-performing clinical trial sites to meet recruitment targets
- Lead or support global Cross-Functional Trial Teams to achieve milestones
- Establish timelines, optimize planning, and identify acceleration opportunities
- Manage stakeholder expectations and ensure alignment with internal and external partners
- Conduct ongoing medical/scientific review of trial data including safety trend analysis and reporting
- Support preparation of CSRs and publications
- Prepare and lead dose-escalation meetings with investigators
- Ensure timely, high-quality clinical data for dose-escalation decisions and Phase II reviews
- Identify study risks and drive mitigation and risk management
- Forecast, manage, and monitor study budgets with stakeholders
- Partner with vendors and internal teams to define strategies, timelines, and deliverables
- Promote trial management best practices and improvement initiatives
- Represent the department in cross-functional projects as a Subject Matter Expert
Zentrale Anforderungen
- Approximately 2+ years of experience in clinical research, trials, or drug development
- Experience managing multiple trials and competing priorities
- Strong understanding of clinical trial methodology, especially in early development
- Operational project management experience with planning and organizational skills
- Experience interpreting, discussing, and presenting trial data
- Strong cross-functional collaboration and stakeholder management
- High learning agility and adaptability
- Excellent communication and interpersonal skills
- Working knowledge of oncology and/or haematology
- Understanding of clinical finance principles and budget management
- Good knowledge of ICH-GCP guidelines, regulatory requirements, SOPs, and best practices in clinical research
Clinical Research Scientist/Coordinator B7 II - CHE in Basel Arbeitgeber: Real Staffing Group
Als innovativer Medizintechnikhersteller im Südwesten Baden-Württembergs bieten wir Ihnen die Möglichkeit, aktiv an der digitalen Transformation und der Gestaltung von Produktlebenszyklen mitzuwirken. Unsere Unternehmenskultur fördert Zusammenarbeit und Kreativität, während wir Ihnen attraktive Vergütung und individuelle Weiterentwicklungsmöglichkeiten bieten. Bei uns finden Sie ein internationales Umfeld mit kurzen Entscheidungswegen, das Ihnen einen hohen Gestaltungsspielraum in Ihrer Rolle als Business Process Engineer ERP (m/w/d) ermöglicht.
