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Job description Main responsibilities Overall project management for phase 2 clinical study, including timelines and resource planning Deliver phase 2 clinical study from initial planning, setup and study conduct until final reporting phase within agreed budget, timelines and with high quality (ICH-GCP and applicable regulations and guidelines) Budget and contract negotiation for CRO/vendors for phase 2 study with subsequent budget, payments and contracts management Act as primary contact person and supervise of selected vendors and ensure high quality study oversight according to study plans, timelines & budget Input to and review of clinical study protocols, ICF, eCRF and other study related documents, from an operational perspective Review and/or approve of study plans (Monitoring Plan, Project plan, Data Management Plan, Safety Plan, SAP, Mock TLFs, DTA) Participate in site selection, study start up, co-monitoring and close out Manage with CRO the regulatory and Ethics Committee submission review Supervision of database close, analysis and study report coordination Assist in set up of clinical quality system, (provide input on gaps in company/CRO SOPs and internal SOPs as needed) Organize cross-functional internal Clinical Study Meetings, prepare agenda and minutes Regular reporting on study conduct and budget to management Ad hoc oversight of other clinical operations contractors and support in close out of ongoing Phase I study Profile PhD or MSc with (bio)medical, pharmaceutical, biochemical or biotechnological background At least 5 years clinical operations and (cross-functional) project management experience at a manager level or higher, preferable also oncology study experience Must have proven experience of managing and coordinating CROs/vendors Structured and highly organized with a pro-active, hands-on attitude Thorough understanding and experience with implementation of GCP Excellent communication skills (oral as well as written) Able to work in a semi-virtual environment Able to work independently and make appropriate operational decisions to execute company strategy and move the clinical trial(s) forward Proficient in MS office (excel, word, power point) Fluent in English (oral and written) Workload and duration (not taking into consideration planned vacation periods, which should be communicated in advance and considered for planning purposes) June – August 2019: 2 days per week September 2019 – September 2020: 4 days per week, likely to be extended by 12-month periods

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