Ann Park
Ridgefield Park,NJ
Summary
Dynamic and results-driven professional with a proven track record of success in site monitoring, clinical trial management, compliance standards, and quality implementation on a global scale. Recognized to work both in an independent and team collaborative environment, leveraging expertise and credibility to devise strategic roadmaps, processes, and approaches to clinical trial management coherent with current industry standards and best practices. Equipped as a Subject Matter Expert (SME) in clinical operations and QMS development with therapeutic experience in Oncology, Pain Management, Device, and Endocrinology with Phase II-IV & Observational Studies. Technologically savvy and agnostic with clinical technologies such as eQMS, EDC, CTMS, IVWR, eTMF and other various platforms.
Overview
21
21
years of professional experience
Work History
Clinical Trial Consultant
Consultant
12.2024 - Current
- Liaise with customer management to better understand needs and recommend appropriate solutions.
- Collaborate with cross-functional teams to successfully deliver comprehensive solutions.
- Manage client relationships through regular check-ins and updates on project progress.
- Key Achievement:
- Evaluate customer needs and expectations, establishing clear goals for each consulting engagement.
Director, GRA, Clinical Trial Excellence
Alexion, Astra Zeneca - Contract
08.2023 - 07.2024
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Facilitated cross-functional collaboration in a highly matrixed environment for improved decision-making processes within the organization.
- Fostered a culture of continuous improvement by fostering open communication channels and empowering sub teams to voice their ideas.
- Key Achievement:
- Proactively identified potential risks to assigned projects and communicated potential mitigation strategies to stakeholders to minimize negative impacts.
Clinical Trial Consultant
Consultant
03.2020 - 02.2024
- Consulted on process development for fit-for-purpose according to customer's needs.
- Develop process road maps to garner stakeholder buy-ins to greenlight projects.
- Liaised with customers and management to better understand customer needs and recommend appropriate solutions.
- Enhanced team productivity with agile methodologies, streamlining project delivery processes.
- Key Achievements:
- Delivered high-quality presentations to stakeholders, effectively communicating project objectives and results.
- Developed and maintained strong client relationships, ensuring high levels of satisfaction and repeat business.
- Collaborated with cross-functional teams to successfully deliver comprehensive solutions for clients.
Strategy & Clinical Compliance Officer
Clinical Professionals Inc.
02.2015 - 03.2020
- Mentored responsible sub project teams in developing and improving process, work instruction, forms/guides to meet current regulatory requirements for a robust Company Quality Management System (QMS).
- Evaluated new regulations for potential impact on clinical trial execution, taking proactive measures to ensure readiness for implementation.
- Promoted a culture of continuous improvement through ongoing evaluation and refinement of clinical trial/studies program elements.
- Conducted direct reports performance reviews and development.
- Collaborated with cross-functional teams to address compliance concerns, fostering a culture of shared responsibility by either developing, reviewing and/or approving standard procedures.
- Key Achievements:
- Ensured transparency and accuracy in clinical operations for GCP sponsor company audits, performing vendor audits and implemented CAPA plans in response to audit findings
- Administered/maintained business critical vendors: collaborated with external IT partner in improving business disaster recovery, developing business continuity plans and were operationally aligned to business model.
Director of Operations
Clinical Professionals Inc.
02.2013 - 04.2015
- Developed high-performing teams by overseeing vendor selection and onboarding to support clinical trial operations in areas of data management (EDC), clinical trial document translations and clinical trial systems
- Nurtured a collaborative team environment for growth/development as well as formulated team training programs to ensure continuous performance improvement
- Key Achievements:
- Achieved fast track promotion to operationally recruit, train and oversee team's day to day tasks.
- As needed, oversaw clinical project teams and project managed high profile accounts.
- Multi-tasked and mentored junior/senior CRAs, as needed.
Global Program Manager
Clinical Professionals Inc.
02.2011 - 01.2013
- Delivered primary CRA task requirements at a regional and global level, including investigational product reconciliation, data query management, Serious Adverse Event (SAE) reporting, and regulatory submissions to ethics committees
- Managed creation and improvements of technical documents from Policies, Standard Operating Procedures to Disaster & Recovery
- Assisted in negotiating contracts with external partners, ensuring adherence to relevant regulatory requirements throughout the partnership lifecycle.
- Key Achievements:
- Met tight deadlines to satisfy clients' demands and project timelines.
- Performed monitoring tasks for 50+ centers globally either as primary monitor, or as co-monitor to supervise monitoring quality assurance and ensuring delivery of corresponding monitoring trip reports to meet KPIs.
- Directed technologies adoption at the enterprise level and oversaw team activities for implementation.
Senior CRA
Clinical Professionals Inc.
02.2009 - 02.2011
- Conducted initiation, monitoring and closeout visits to verify trial procedures, regulatory documents and data completion.
- Communicated project status to trial management team through technical documentation and presentations.
- Reviewed participant eligibility and consent documentation to ensure data accuracy as well as perform Source Data Verification (SDV).
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Key Achievements:
- Optimized study startup times by proactively addressing potential bottlenecks and refining site selection criteria.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
Clinical Trials Consultant
Consultant
06.2004 - 02.2009
- Collaborated across multiple cross-functional teams to deliver clinical trial objectives in different enterprise environments: Merck, J&J Cordis, Pfizer.
- Spearheaded audit/inspection preparation activities within a team setting.
- Contributed to the development of study protocols, informed consent forms, and case report forms (CRFs) to ensure consistency across clinical trials.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Key achievements:
- Operationally readied clinical sites for global trials from phase II-IV trials to meet trial timelines.
- Managed field CRAs as inhouse CRA lead and clinical trial monitoring deliverables.
Education
Black Belt
Go Lean Six Sigma (GLSS)
11-2024
ISO 9001 Lead Implementer
The Knowledge Academy
06-2022
Lead Auditor - ISO 9001
The Knowledge Academy
06-2022
Certified Clinical Research Associate
Association of Clinical Research Professionals (AC
09-2013
Certified Scrum Master - undefined
Scrum Alliance
09.2012
Master of Science - Health Care Policy & Management
School of Health Technology & Management
Stony BrookBachelor of Science - Biochemistry
State University of New York - StonyBrook
NYSkills
- Problem-solving
- Attention to detail
- Team leadership & development
- Continuous improvement
Timeline
Clinical Trial Consultant
Consultant
12.2024 - Current
Director, GRA, Clinical Trial Excellence
Alexion, Astra Zeneca - Contract
08.2023 - 07.2024
Clinical Trial Consultant
Consultant
03.2020 - 02.2024
Strategy & Clinical Compliance Officer
Clinical Professionals Inc.
02.2015 - 03.2020
Director of Operations
Clinical Professionals Inc.
02.2013 - 04.2015
Global Program Manager
Clinical Professionals Inc.
02.2011 - 01.2013
Senior CRA
Clinical Professionals Inc.
02.2009 - 02.2011
Clinical Trials Consultant
Consultant
06.2004 - 02.2009
Certified Scrum Master - undefined
Scrum Alliance
Black Belt
Go Lean Six Sigma (GLSS)
ISO 9001 Lead Implementer
The Knowledge Academy
Lead Auditor - ISO 9001
The Knowledge Academy
Certified Clinical Research Associate
Association of Clinical Research Professionals (AC
Master of Science - Health Care Policy & Management
School of Health Technology & Management
Bachelor of Science - Biochemistry
State University of New York - StonyBrook
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