The Clinical Operations Specialist is expected to perform hands-on clinical operations activities with minimal supervision, as well as provide leadership, supervision, and technical guidance to Clinical Research Associates, Clinical Trial Assistants, and contract Clinical Operations personnel.
- Clinical trial execution and oversight: Oversee implementation of clinical trials by managing the timeline, resources, budget, and staff of clinical activities to achieve the study objectives
- Write clinical protocols and protocol-associated documents including Informed Consent Forms, Clinical Monitoring Plans, and other documents as needed or requested
- Supervise study team members including Clinical Research Associates and Clinical Trial Assistants
- Develop study feasibility and cost estimates for outsourced clinical operations activities
- Interface effectively with other groups within the organization
- Work closely with Immunology personnel on clinical laboratory activities including specimen management
- Collaborate with Supply Chain personnel to produce investigational product forecasts and identify distribution, storage, and accountability requirements
- Collaborate with Finance personnel to provide financial information related to clinical development, including budget forecasts.
- Participate on core project teams and study teams as needed or requested
- Ensure appropriate trial operational infrastructure:
- Assist in developing staff and creating a desirable work environment in order to attract and retain qualified clinical operations professionals
- Ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines
- Evaluate and implement tools and processes to improve operational efficiency
Technical Skills and Knowledge:
- Strong communication skills (verbal and written); effective in interaction with senior and junior colleagues
- Current knowledge of FDA and ICH GCP regulations and guidelines
- Software knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint), and Adobe Professional
- Good judgment and problem solving skills
- Ability to think strategically and tactically in order to prioritize and delegate tasks
- Entrepreneurial spirit with “can do” attitude and initiative
- BA/BS degree or higher, preferably in the life sciences
- Minimum of 7 years prior relevant experience in the pharmaceutical/biotech industry or relevant clinical research organization, with a minimum of 2 years management experience
- Demonstrated project management/clinical operationsexperience and leadership skills (e.g. managing cross functional study teams, managing outside collaborators)
- Vaccine clinical trial experience is required
- Experience with Phase IV trials
- Needs to have an understanding of the cost of such trials and the challenges associated with them (i.e., patient enrollment).
- Needs to have opinion on trials costs, and recruitment for ID vaccines e.g. Chikungunya would be a nice to have.