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Clinical Project Manager(s) Multiple opportunities are available for experienced Clinical Trial Professionals!! PRIMARY RESPONSIBILITIES: • Manage clinical trial process to ensure studies are completed on time and within budget. • Manage the writing and review of protocols, case report forms and study reports. • Assist the medical monitors during the preparation of study reports. • Develop clinical monitoring plans and study monitoring priorities. • Develops relationships with investigators and site staff. • Provide leadership, guidance, and clinical trial management expertise to in-house and contract staff. • Manage studies to ensure they are conducted in compliance with SOPs, FDA regulations and ICH/GCP guidelines. • Use operational and therapeutic expertise to optimize trial design and execution. QUALIFICATIONS: • Bachelor's degree required. Advanced degree preferrable. • A minimum of 5 years experience in clinical monitoring is required • Must have a working knowledge of GCP processes as well as FDA and ICH guidelines. |