Description
Responsibilities:- Develops and implements clinical plans for projects consisting of multiple studies in support of product design validation and claims. Applies extensive technical expertise, and has deep knowledge of other related disciplines such as statistics and data management.
- Interprets and describes complex data. Creates complex, coherent, professional documentation such as clinical reports. May lead a team to compose draft manuscripts for publication. Develops study and program resource plans and budgets.
- Develops and maintains collaborative relationships with investigational sites and client company personnel.
- Responsible for completing study preparation tasks, which include protocol; clinical department plans and CRF design support and ensuring adequate material/method management at the sites
- Is accountable for Clinical Operation decisions as related to a specific discipline or project. Interacts independently with clinical investigators and may interact with KOLs.
- Ensures availability of required supplies and/or resources for individual and/or group activities.
- Knowledge of ICH / Good Clinical Practices and other Regulations and/or Guidance's relative to the conduct of clinical trials worldwide
- Demonstrated ability to complete all aspects of clinical study development: preparation, conduct, and close-out.
Qualifications:
- A minimum of a Bachelor's degree in life sciences; Advanced degree preferred
- A minimum of 5 years IVD, medical device experience
- A minimum of 3 years hands on laboratory experience.
- Must be able to travel up to 50%
- Individuals with demonstrated direct clinical trials experience, preferably within the Diagnostic, IVD or medical device industry are highly desired.
- Individuals with Clinical laboratory experience and flow cytometry experience highly desirable
To find out more about Real Staffing please visit www.realstaffing.com