Clinical Trial Operations Manager - United States
Provides input into identifying implications of study progress on overall timeline goals and conduct plans. Provides input into content and execution of investigator meetings and may present selected topics. With oversight, develops informed consent form and coordinates input. With oversight, provides point of contact for site questions relating to study conduct issues. Participates in the implementation of key organizational process improvement initiatives. Responsible for serving as clinical trial leader for a large-scale multi-country trial (Phases II-IV). Responsible for protocol preparation, generation of manuals for trial support committees and other trial documentation. Lead the multi-disciplinary team responsible for study completion. Writes and reviews abstracts/manuscripts, etc. for presentation/publication at internal/external meetings. experience in Clinical Trials or Clinical Project management.
Capable of interacting effectively with scientists and managers within and outside Trial Operations Department.
- Strong interpersonal and communication skills (verbal and written)
- Ability to handle multiple task and to prioritize, strong organizational and presentation skills
- Leadership / Vendor Management skills
- Project Management skills
- Decision-making and problem-solving skills
- Ability to work autonomously and to efficiently & effectively provide status reports
- Ability to anticipate and timely escalate issues and to define appropriate action plans
- 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
- Experience in managing and leading international meetings (Clinical Trial Team, expert meeting,
- 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)
- Ability to adapt and be flexible to change and managing internal and external impediments
- Understanding of data base concepts preferred
- Knowledge or ability to rapidly gain knowledge with programming/query languages
- Knowledge of industry data management standards and practices
Bachelor's degree (advanced degree preferred) plus at least 3 years of experience in pharmaceutical
industry or clinical-related discipline including at least 2 years clinical research experience, including
2 years of trial operations management.