job summary: Job Title:
Clinical Trial Operations Manager III Job Summary
Education & Qualifications
- 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 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.
- Bachelor's Degree Required
- 7 years of experience in pharmaceutical industry or clinical-related discipline including at least 5 years clinical research experience, including 2 years of trial operations management.
- Familiarity and direct previous experience with OTC Switch studies is required"
- Strong interpersonal and communication/ presentation skills (verbal and written);
- Ability to handle multiple tasks and to prioritize, strong organizational skills
- Leadership & Project Management skills; positive, "can do" attitude, includes effective vendor and stakeholder management, risk management planning,
- 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, etc)
- 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 database concepts preferred
- Familiarity and direct previous experience with OTC Switch studies is required".
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
location: Bridgewater, New Jersey
job type: Contract
salary: $60.18 - 70.80 per hour
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.