1099 Clinical Trial Management Consultant (remote)

Company: BioPhase
Location: Milwaukee
Posted on: June 25, 2022

Job Description:

SUMMARYThe Clinical Trial Management Consultant is responsible for the execution of clinical trial protocols in compliance with Good Clinical Practices and applicable regulatory requirements. They will oversee/manage the day-to-day operations of one or more clinical trials including trial start-up, conduct, and close-out activities. They are expected to deliver high quality output within timelines and established budget parameters.Must be an established independent consultant operating as a 1099RESPONSIBILITIES

• Proactively manage all aspects of clinical trial conduct; identifies, resolves and escalates issues
• Lead the Clinical Trial Team consisting of members from other functional areas (i.e., Data Management, Regulatory Affairs, Clinical Supplies) to ensure that trial timelines, budget, and quality metrics are met
• Ensure clinical trial conduct is in compliance with ICH, GCP, and local regulations
• Collaborate with the Clinical Project Lead to identify and manage risks; develop and implement risk mitigation plans
• Establish study milestones and ensures accurate tracking and reporting of study metrics
• Develop and implement study plans (e.g., monitoring plans, contingency/risk mitigation plans)
• Provide operational expertise in clinical trial development and execution including input to clinical protocols, clinical study reports, and CRF design
• Plan and conduct study specific training (i.e., CRO training, Investigator Meeting, Site Initiation Visits)
• Make recommendations for the identification and selection of study vendors
• Assist with vendor budget negotiation, development of scope of work, and contract execution
• Manage study vendors (i.e., CRO, Central Laboratory); ensuring deliverables are met and issues are proactively identified and resolved
• Oversee forecasting of clinical and non-clinical supplies
• Collaborate effectively with the Clinical Project Lead and Clinical Operations study team, cross-functional team members and external partners
• Manage clinical trial budgets within established limits
• Perform quality control activities (i.e., co-monitoring visits, Trial Master File audits)
• Approve vendor invoices
• Provide study-specific direction and mentoring to Clinical Research Associates, and support staff, as appropriate
• Provide support and mentoring to other Clinical Trial Managers, as appropriate
• Participate in Clinical Operations initiatives and programs, as needed
• Present at Sr. Management meetings, as required
• May have direct management responsibilities for Clinical Trial Managers and/or Clinical Research AssociatesCOMPTENCIES
• Proven ability to deliver high quality clinical trial execution
• Highly developed leadership skills to successfully lead the Clinical Trial Team
• Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, vendor oversight strategies
• Effective in establishing and managing trial timelines and budgets (including forecasting)
• Effective written and verbal communication skills
• Solid analytical and proactive problem-solving skills
• Ability to think globally and strategically
• Exceptional attention to detail
• Strong interpersonal and sound conflict resolution skills
• Outstanding organizational skills with the ability to multi-task and prioritize
• Proven flexibility and adaptability
• Strong and positive work ethic
• Good presentation skillsREQUIREMENTS
• Bachelor's Degree preferred
• Minimum of three (5-7) years of clinical research experience; direct experience in managing Phase I through Phase III global clinical trials preferred
• Therapeutic knowledge preferred
• Experience/training in the following areas: GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process, Data Management Overview
• Knowledge of Ex-US regulations a plus
• Proficiency in MS Office including Word, Excel, and PowerPoint; Project and Visio a plus

Keywords: BioPhase, Milwaukee , 1099 Clinical Trial Management Consultant (remote), Professions , Milwaukee, Wisconsin