Summary
Overview
Work History
Education
Skills
Certification
Publications
Timeline
Generic

Medea Michelle Eckel

Omaha

Summary

Research professional with deep expertise in managing complex operations. Skilled in optimizing processes, enhancing data integrity, and driving impactful research initiatives. Strong focus on team collaboration, achieving results, and adjusting to evolving project needs. Known for problem-solving, strategic planning, and effective communication. Proven track record in streamlining processes and enhancing team productivity through strategic planning and effective resource allocation. Demonstrated strong leadership and analytical skills to drive successful project outcomes.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Clinical Research Operations Manager

FARE (Food Allergy Research and Education)
05.2021 - 01.2025
  • Lead study operational strategy and planning. Oversee execution of clinical studies for assigned clinical programs, supporting clinical strategy defined in the Clinical Development Plan.
  • Manages activities associated with complex biomedical research including investigator and industry-initiated studies.
  • Tracks and maintains study timelines.
  • Directly interfaces with clinical research coordinators and site staff who support funded clinical research.
  • Assures protocol adherence and compliance by providing oversight and advisory support to individual coordinators.
  • Development of study budgets.
  • Provides ongoing internal monitoring of quality and compliance both by informal and scheduled assessments of work products at specified time points.
  • Identifies non-compliance events and guides corrective action.
  • Develops training and improvement plans.
  • Provides direct support for Principal Investigators and research coordinators during external audits.
  • Conducts study feasibility analysis for proposed new trials.
  • Assists in development and maintenance of defined systems for implementation of protocols, including templated source document forms, recruitment strategies, supply inventories, Manual of Procedures, and SOPs
  • Interact with other functional areas and key stakeholders, including but not limited to Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Drug Safety and Pharmacovigilance, Clinical Supply, Medical Affairs, and Clinical vendors (e.g., central lab, CROs, imaging vendors) to support clinical trial activities

Clinical Research Manager

Adult Pediatric Urology and Urogynecology
01.2020 - 01.2021
  • Responsible for providing day to day oversight of the research department. Acts as a liaison between Physician’s, Administrator, and research staff.
  • Responsible for tasks that relate to the operations and management of clinical trials.
  • Responsible for executing company objectives: resources, timelines, budgets, contract relationship management, identification of project risks, and contingency plans.
  • Effectively manage the clinical research team: Attract, manage, retain, and coach
  • Provide ongoing educational and motivational support to the research team
  • Support and achieve all corporate goals and initiatives relative to the department
  • Foster collaborative relationships with key functions
  • Drive a positive, collaborative, and results-oriented culture within the team
  • Execute clinical development program from protocol design collaboration to the final clinical study report for assigned studies
  • Create and maintain Clinical Standard Operating Procedures (SOPs), systems and processes across study trials
  • Manage study sites and tracking systems for enrollment of subjects, regulatory document flow, study timelines, financial information, SAE, performance metrics and data flow
  • Ensure clinical trial compliance with all regulatory regulations and standards domestically and internationally
  • Engage Key Opinion Leaders in clinical dialog around study design, conduct and interpretation of clinical results
  • Identify training and development needs of assigned staff. Assist in the development, implementation, and delivery of departmental training programs; ensure that assigned staff receive departmental orientation and necessary on the job training
  • Assist in monitoring performance of assigned staff. Assist in providing regular coaching and counseling

Clinical Trial Project Manager

Center for Translational Research-Catholic Health Initiatives
01.2011 - 01.2020
  • Responsible for planning, scheduling, and implementing the clinical aspects of projects in line with contract and budget; implementation of protocol and amendments; protocol deviation prevention, tracking and reporting; IP management
  • Identify and escalate impacts to project scope, resources, schedule or budget through standard methods
  • Ensure project leadership personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
  • Assists with plans and management of day-to-day operational aspects of one or more assigned programs/projects or tasks, including the following, as required: planning/timelines, budgeting/resourcing, and vendor management/interfacing.
  • Identifies and proactively works to remove obstacles, mitigate risks, and escalates issues; both internally and to the client
  • Interact with study sponsors as primary point of escalation beyond project management
  • Optimize the profitability of the Project Management organization to meet or exceed budget targets
  • Assess and manage resource allocations to ensure that established cost, time, and quality goals are met
  • Responsible for the development and maintenance of operational plans for clinical deliverables, CRF completion guideline, Clinical Monitoring Plan (CMP), Recruitment Plan, Training Plans, etc.
  • Proactively identify and resolve operational issues/processes to ensure achievement of study milestones, data quality, and data integrity
  • Meeting financial objectives by forecasting requirements and analyzing variances; initiating corrective actions
  • Ensure that all projects are delivered on time, within scope and within budget
  • Develop a detailed project plan to monitor and track progress
  • Maintain and ensure TMF and TMF documentation is in a state of audit-readiness and is thoroughly QC’d by cross-functional members at study closure
  • Enhances department and organization reputation by accepting ownership for accomplishing new and different requests
  • Perform risk management to minimize project risks
  • Create and maintain project documentation
  • Ensure resource availability and allocation

Education

Master of Healthcare Administration -

Bellevue University
Bellevue, Nebraska
01.2015

Bachelor of Science - Medical Imaging

Clarkson College
Omaha, Nebraska
01.2005

Associate of Science - Radiologic Technology

Clarkson College
Omaha, Nebraska
01.2003

Skills

  • Collaborative research
  • Interdisciplinary approach
  • Adaptive learning
  • Clinical trial expertise
  • Problem-solving
  • Research management
  • Teamwork and collaboration

Certification

ACRP Certification September 12, 2009 #1598054

Publications

Measuring neurodevelopmental effects of polygenic risk for Alzheimer’s disease via longitudinal study of brain and cognitive variables in periadolescent children.

Timeline

Clinical Research Operations Manager

FARE (Food Allergy Research and Education)
05.2021 - 01.2025

Clinical Research Manager

Adult Pediatric Urology and Urogynecology
01.2020 - 01.2021

Clinical Trial Project Manager

Center for Translational Research-Catholic Health Initiatives
01.2011 - 01.2020

Bachelor of Science - Medical Imaging

Clarkson College

Associate of Science - Radiologic Technology

Clarkson College

Master of Healthcare Administration -

Bellevue University

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