Aufgaben

- Core member of the clinical trial team
- Collaborates closely with the Clinical Physicians on relevant trial-related activities
- Develops a sound understanding of the science and medicine related to an indication and trial and performs literature searches as needed to keep knowledge up to date
- Main deliverables include the clinical trial protocol and related documents such as the ICF, study committee charters, study guidelines/instructions, PD code list, subject narratives, and the CSR
- Provides input into and reviews cross-functional trial documents such as the SAP, ESP requirements and specifications, monitoring guidelines, data review manual
- Performs data review and medical monitoring
- Coordinates/manages the study committees
- Provides scientific input into responses for IRBs/ECs and HAs
- Participates in discussions with external experts
- Trains the relevant functions and roles on the scientific aspects of the study
- Contributes to cross-functional and clinical development initiatives and processes as needed

Qualifikationen

- PhD, Pharm D, MSc or equivalent university degree in life or health sciences
- At least 2 years of working experience preferably in clinical development in a contract research organization (CRO) or pharmaceutical company
- Previous experience in either the planning, set-up, conduct, closing, and reporting of phase II and III clinical studies from a scientific perspective (candidate with clinical trial experience is preferred)
- Fluent in English (written and oral)
- Good organizational, problem solving, and interpersonal & communication skills
- Ability to work independently and within a cross-functional team to prioritize and coordinate multiple competing tasks
- Ability to work under pressure and meet short timelines without compromising quality
- Results driven attitude and good sense of urgency
- Able to anticipate and proactively address issues and demands
- Analytical thinking and data and detail oriented
- Shares knowledge and expertise openly
- Effectively negotiates with key stakeholders to influence, convince, and gain their buy-in and agreement
- Thinks globally and has an appreciation and understanding of the big picture (e.g., competitor activities, potential implications and consequences of own activities and decisions)
- Able to travel occasionally as required to fulfil responsibilities and tasks