Lotus Clinical Research Project Manager

Responsibilities

• Manages and executes the overall project scope, budget, and timelines.
• Identifies project success factors for analysis, reporting, and tracking.
• Manages resources and timelines associated with all study start-up and implementation activities.
• Led the development of study specific protocols, consent forms, and other trial related materials as required.
• Ensures the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.
• Participates in the review of clinical data for analysis.
• Serves as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.
• Plans for and manages all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational devices.
• Maintains adherence to project contract and budget.
• Captures and coordinates with clinical, business development, and operations management to identify goals and scope of clinical study projects.
• Ensures operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed.
• Supports the management and oversight of clinical study related vendors.
• Reviews site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements.

Qualifications

• Bachelor’s degree or equivalent education/degree in life science/healthcare is required accompanied by 5 years of working within clinical research at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program.
• CRO experience is highly desirable.
• Experience managing external vendors preferred.
• Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies preferred.
• Experience writing, reviewing and editing protocols and clinical study reports as well as working knowledge of the FDA submission process preferred.