Description
DESCRIPTION:Will be responsible for working collaboratively with the Clinical Lead and members of the Clinical Sub-Team and Alliance Partner to develop and implement one or more clinical protocols; Will contribute to the design of and will independently author protocols and protocol amendments while focusing on optimizing clinical trial design; In conjunction with the clinical lead will conduct review and interpretation of efficacy and safety data for ongoing clinical trials; Primary point of contact for technical, clinical, and scientific aspects of clinical trials at the study level; Collaborates as appropriate with other groups.
REQUIREMENTS:
Understanding and experienced with Clinical Trail Management (More medical - eg able to write a protocol, assist with CRF development, conduct medical review, etc. rather than operational activities); Pharma or CRO experience is a MUST; Experience with Inflammation TA preferred.
SKILLS
FDA Regulations, Clinical Study Design/Management and Monitoring, Clinical Documentation, Clinical Research
Synectics is an Equal Opportunity Employer.