Description
ResponsibilitiesThe Clinical Trial Manager (CTM) will be responsible for the day-to-day operational management and oversight of all aspects of clinical trials in a small company environment. The CTM will closely partner with the Medical Monitor, Drug Safety, Clinical Data Management, Regulatory/QA, etc. as well as other cross-functional team members/clinical CRO, vendors, and staff to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget. CTM will exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. This individual will report into the Sr. Director of Clinical Operations. Approximately 25% travel is required. This is an in-house position. No relocation.
Qualifications
- Bachelor's degree in health related science and/or nursing degree (RN)
- At least 4 years of clinical operations work experience and a working knowledge of GCP/ICH guidelines and the clinical development process.
- Experience in managing industry sponsored clinical (pharmaceutical) programs.
- Oncology experience a plus
- Selection, oversight, and management of external vendors
- Management of international clinical studies is a plus
- At least 2 years of team leadership experience
- Experience developing trial plans including: site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
- Previous experience working with an electronic data capture system required
- Proficient with MS Word, Excel, Project and PowerPoint
- Strong interpersonal, communication (written and verbal), and organizational skills
- Demonstrated ability to work independently as well as part of a multi-functional study team
- Able to motivate a team to work effectively under a changing environment
- Able to solve problems under pressure
- Self-motivated and able to work effectively in a matrix/team environment