Clinical Trial Operations Manager
The CTOM is responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, observational studies, compassionate use and registries) including oversight of data management activities in compliance with GCPs, SOPs and standards within established timelines and budgets.
The CTOM is involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of homogeneous high quality data, in close collaboration with other functions (e. g. Medical Operations, Monitoring Team, Biostatistics) and with the CRO, for outsourced trials.
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.
- Prior experience with pediatric studies preferred
- Able to work on site at least 3 days per week
10 years of experience in pharmaceutical industry or clinical-related discipline including at least 7 years clinical research experience, including 4 years of strong trial operations management experience across all study periods (start-up, maintenance and closure).