Heidi Moran
Summary
Accomplished Vice President bringing 25 years of experience and demonstrated successful history of leadership and clinical research operations accomplishments. Experience managing and driving change to promote continuous operational improvement. Employed multi-prong strategy to build and streamline internal systems, enhance revenue and extend profits.
Overview
26
26
years of professional experience
Work History
President/Owner
MidAtlantic Consulting Services
09.1998 - Current
- Developed and implemented comprehensive risk management programs to mitigate potential liabilities.
- Reduced operational costs through strategic cost management initiatives.
- Monitored key business risks and established risk management procedures.
- Represented organization at industry conferences and events.
- Cultivated strong relationships with external partners to foster collaboration and maximize resources.
- Successful strategic solutions leadership in driving client services delivery, and ensuring key timelines are met with the highest of industry standards and practices.
- Successful building of strong and competent personnel infrastructure across functioning areas.
- Supported project management team for optimal performance.
Vice-President, Clinical Operations
Direct Biologics, LLC.
08.2020 - 11.2022
- Generated and implemented business strategies to increase revenue while executing operational base development.
- Coordinated budget of $80 Million and teams of staffing across multiple locations with stellar record of meeting or exceeding demanding targets.
- Determined performance goals and offered tactics for achieving milestones.
- Hired and managed 30 employees to maximize productivity while training staff on best practices and protocol.
- Communicated regularly with executive team members to deliver pertinent details related to progress status and direction for projects.
- Spearheaded cross-functional initiative to achieve business goals driving increased revenues and profits.
- Cultivated and maintained positive working relationships with employees, executives and other stakeholders.
- Initiated on-time, under-budget project management to optimize performance.
- Coordinated work across departments to keep teams on track with company goals.
- Implemented best practices to strengthen internal regulatory, data management, GMP/GCP requirements and spearhead proactive change.
- Collaborated with senior management to develop strategic initiatives and long term goals.
- Established performance goals for department and provided methods for reaching milestones.
- Established and directed successful programs focused on globalization of programs and marketing.
- Negotiated contracts with leading clientele, encompassing industry-leading organizations and multitude of projects.
Project and Site Manager
Formerly PRA, Now ICON
01.2007 - 04.2016
- Coordinated site investigations, documented issues, and escalated to executive teams.
- Assisted in organizing and overseeing assignments to drive operational excellence.
- Ensured compliance with local regulations, per ICH GCP standards.
- Developed strong relationships with clients through consistent communication of project updates and prompt resolution of concerns or issues.
- Defined clear targets and objectives and communicated to other team members.
- Identified and communicated site needs to supply chain capacity and quality teams.
- Conducted regular site meetings with team members, fostering open communication channels for efficient problem-solving and progress updates.
- Enhanced project efficiency by implementing streamlined processes and procedures for site management tasks.
- Established team priorities, maintained schedules and monitored performance.
- Evaluated employee performance and conveyed constructive feedback to improve skills.
- Complied with best operating practices and assessed operational procedures against best practices.
- Skilled at working independently and collaboratively in a team environment.
- Demonstrated creativity and resourcefulness through the development of innovative solutions.
- Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Worked well in a team setting, providing support and guidance.
- Worked effectively in fast-paced environments.
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
Director of Clinical Operations
Sirion Therapeutics (closed)
08.2006 - 01.2007
- Established and enforced clear goals to keep employees working collaboratively.
- Identified and corrected performance and personnel issues to reduce impact to business operations.
- Coached and trained newly hired employees so that each understood job responsibilities and requirements of positions.
- Ensured regulatory compliance by staying informed of industry standards and maintaining thorough documentation practices.
- Mentored junior staff members, contributing to the development of a high-performing, cohesive team focused on achieving departmental goals.
- Streamlined patient enrollment process, increasing participant numbers in clinical trials without sacrificing quality or safety standards.
- Developed comprehensive risk management plans to minimize potential issues in clinical operations.
- Facilitated knowledge sharing among staff through organized training sessions, workshops, and conferences on best practices in clinical operations management.
- Managed crisis situations effectively as they arose; swiftly identifying root causes, formulating action plans, executing decisive action steps to resolve issues, and prevent recurrence.
- Planned and managed adherence to project budget and contracts and assisted in identification and development of scope change documents.
- Led cross-functional teams for successful project execution within established timelines.
- Established and maintained contacts at various management levels regarding clinical operations department and specific projects.
- Developed, implemented, revised, and evaluated policies and procedures.
- Gained strong leadership skills by managing projects from start to finish.
- Acted as a team leader in group projects, delegating tasks and providing feedback.
- Identified issues, analyzed information and provided solutions to problems.
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
- Developed and maintained courteous and effective working relationships.
- Participated in team projects, demonstrating an ability to work collaboratively and effectively.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
Education
Bachelor of Science - Biochemistry And Math
Drexel University
Philadelphia, PA05.1998
Skills
- Solution Innovation
- Performance monitoring and evaluation
- Global regulations
- Trend Identification and Forecasting
- Staff development
- Budget oversight
- Risk management
- Performance data analysis
- Cash Flow and Financial Analysis
- Forecasting
- Process Optimization/Improvements
- Market trends and analysis
- Industry Best Practices: GCP, GMP
- Solution Innovation
Accomplishments
- CCRA; ACRP
- Risk Based Management Certified
- ·Current CME Certifications: ICH GCP; Consent Forms, review and processes; International Ethical Guidelines in Clinical Research; Clinical Audit Training; Recruitment and Retention Training
- Past Board of Directors Member, VP and Secretary, Greater NJ Chapter ACRP
Timeline
Vice-President, Clinical Operations
Direct Biologics, LLC.
08.2020 - 11.2022
Project and Site Manager
Formerly PRA, Now ICON
01.2007 - 04.2016
Director of Clinical Operations
Sirion Therapeutics (closed)
08.2006 - 01.2007
President/Owner
MidAtlantic Consulting Services
09.1998 - Current
Bachelor of Science - Biochemistry And Math
Drexel University
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