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1099 Clinical Trial Management Consultant (remote)

Company: BioPhase
Location: Greenville
Posted on: January 9, 2022

Job Description:

The 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.

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 Associates

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 skills

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, Greenville , 1099 Clinical Trial Management Consultant (remote), Healthcare , Greenville, South Carolina

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