Requirements
- Responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, observational studies, compassionate use and registries)
- Oversight of data management activities in compliance with GCPs, SOPs and standards within established timelines and budgets
- Involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of homogeneous high quality data
- Capable of interacting effectively with scientists, support functions, subject matter experts and managers within and outside department
- Serve as internal consultant on assigned area and liaise with external organizations on projects
- Strong interpersonal and communication/presentation skills (verbal and written)
- Ability to handle multiple tasks and to prioritize, strong organizational skills
- Leadership & Project Management abilities: ability to conduct effective and efficient international team meetings (Clinical Trial Team, expert meeting, etc), demonstrate good collaboration skills, have a positive, “can do” attitude, be proactive
- Capability to perform effective vendor and stakeholder management including budget management, active and effectual oversight of CROs
- Possess a solid understanding of data management activities (eCRF development from protocol design, database concepts, data flow, data cleaning, etc.)
- Decision-making and problem-solving skills
- Ability to work autonomously and to efficiently & effectively provide status reports
- Ability to anticipate, identify and timely escalate issues and to define appropriate action plans
- Ability to anticipate, identify and mitigate risks, including their likelihood, scope and impact and to develop CAPAs
- Good cross-functional team leader who fosters team spirit and team motivation (team work)
- Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems), processes and SOPs
- Ability to work in an international environment with internal and/or external partners (CROs etc)
- Strong English skills (verbal and written if English is the second language)
- Competence to adapt and be flexible to change and managing internal and external impediments
- Ability to “think outside of the box” and make adjustments/create action plans to meet timelines
- Able to work on site at least 3 days per week
Nice to Have
- Prior experience with pediatric studies
Work Arrangement
Hybrid
