Description
Overview:Responsible for overseeing all clinical activities related to one or more clinical studies and performing/managing the daily in-house operations associated with the studies. This position should be able to independently handle various clinical study assignments.
Responsibilities:
- Responsible for conducting clinical programs consistent with applicable regulations, guidelines, and policies.
- Research, prepare, and revise the Investigational Plan (study protocol, Instructions For Use (IFU), report of prior Investigations, bibliography, Case Report Forms (CRFs), etc.) and other appropriate sections of the Investigational Device Exemption (IDE) in consultation with the cross-functional project team, investigators, data management, and biostatistics.
- Provide management review and approval of relevant clinical documents.
- Supervise site initiation activities. Oversee set-up and maintenance of accurate study status and implant logs.
- Develop and manage cost center budget and study budgets. Ensures appropriate resources and priorities are maintained for the various projects assigned to their area.
- Collaborate with Clinical Operations department to coordinate field staff and clinical site activities with study needs.
- Evaluate clinical data/information, write, and revise annual, interim, and final reports and clinical sections of Pre-Market Approval (PMA) submissions.
Requirements:
- Bachelor's degree (technical or non-technical). Technical degree defined as engineering, life sciences or related medical/scientific field
- Masters degree will substitute for 1 year of experience. PhD or MD will substitute for 2 years of experience.
Experience managing clinical trials from start to finish. - 4-7 years clinical study personnel management experience (i.e., direct people management).
- Strong knowledge of monitoring functions.
- Strong knowledge of clinical research study design.
International clinical and/or regulatory experience - Travel as required
To find out more about Real please visit www.realstaffing.com