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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

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