This position will provide leadership for all clinical operations activities, ensuring the successful planning, execution and completion of clinical trials as well as lead the setting up and smooth running of a clinical operations department.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Oversee the Clinical Trial and Program managers in planning, setting up and executing and completing assigned clinical trial(s) on time, budget and to required quality
- Operate as Clinical Trial Manager (for INP103 and INP105 studies), with support, until company success and growth allows delegation
- Oversee the development of trackers to monitor project compliance and performance
- Input into clinical development strategy; regulatory document generation and general department development processes (e.g. training; electronic filing system; career progression; staffing levels)
- Lead development and editing of study related materials (synopses, protocols, ICFs, IFUs, and work of CROs on CTNs, PMPs, Communication plans, Safety Management Plans, DMPs, SAPs, CSRs etc)
- Oversee distribution of Clinical Trial supplies and maintenance of tracking information
- Lead clinical team meetings and oversee action item completion
- Oversee clinical coordination with internal (Research, Engineering, Regulatory, and Quality) colleagues and external vendors (esp. CROs) and sites.
- Liaise with the Chief Medical Officer at all times during clinical execution of any Impel study and deputize for CMO if/when required.
EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
- Bachelor’s Degree in a science, health, or related field, preferably with a Master degree or PhD
- 10+ years relevant experience in pharmaceutical industry or CRO in clinical research
- Extensive experience supporting, and considerable experience leading clinical trial execution either with in-house staff or overseeing execution by a CRO.
- Good knowledge of drug development, FDA, and GCP regulatory guidelines
- Excellent oral and written communication
- Excellent organizational and problem-solving skills
- Proven ability to learn and adapt in an evolving work environment
- Proficiency with MS Word, Excel, PowerPoint and Adobe Acrobat