Jenn Pages
Miami,FL
Summary
Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities. Certified by SOCRA. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Project Manager
ICON plc
Remote
09.2023 - Current
- Proactively manage project level operational aspects of Clinical Trial Team (CTT) including management of trial timeline, budget, resources and vendors
- Provide efficient updates on trial progress to Clinical Program Director (CPD) and/or Senior Director of Clinical Operations (DCO), with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation
- Lead sponsor study startup process, including but not limited to conduct of Trial Kick-off meeting, set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets
- Ensure effective project plans are in place and operational for each trial and work proactively with Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements
- Ensure potential study risks are escalated to attention of CDP when appropriate
- Chair CTT working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in Trial Master File (TMF) in timely manner
- Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in timely manner
- Monitor quality of vendor deliverables, address quality issues with appropriate team member and identify opportunities to improve training, execution and quality control across clinical team
- Review and approve vendor invoices in collaboration with Accounting team to ensure investigator payments occur in timely manner
- Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements
- Ensure all project level study documentation is filed in TMF in accordance with company SOPs/all regulatory requirements and provide oversight to clinical team regarding TMF filing, maintenance and archival procedures
- Effectively provide support to Clinical Site Manager(s) in conduct of trials
- Other duties as assigned.
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Planned, designed, and scheduled phases for large projects.
- Met project deadlines without sacrificing build quality or workplace safety.
- Established effective communication among team members for enhanced collaboration and successful project completion.
- Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
- Identified plans and resources required to meet project goals and objectives.
- Collaborated closely with senior management to align project objectives with strategic company initiatives, ensuring that efforts contributed to overall business growth.
- Coordinated with cross-functional teams to resolve project issues and mitigate risks.
- Prepared and submitted project invoices for review and approval.
- Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
Clinical Trial Manager
ICON Plc
Remote
01.2022 - 09.2023
- Manages all study site related activities in a project with a low to medium complexity
- Acts as regional OSM in an international/global project in support of a global OSM
- Responsible for Project Planning, Set Up and Conduct, Communication and Reporting, Training and Oversight
- Plans for all activities in a project related to investigational sites and generates the related planning documents depending on the scope of work
- Serves as primary liaison for the client for all site related issues, including but not limited to start up, site management and applicable clinical monitoring issues, escalating as required
- Addresses and resolves internal and external issues related to site management for client research projects
- Provides data as required for clinical operations performance metrics and project status metrics
- Responsible for design and set-up of various analytic tools/dashboards to assess study status and site performance, and to aid in site management and prioritization of related tasks
- Defines and provides project-specific training for the site management and regional monitoring team and ensures relevant training is completed before the team members start on a specified task
- Creates and maintains applicable project documents, templates and tools, including but not limited to training material
- Leads the site management and regional monitoring team on a project, providing oversight and mentoring as required
- Manages site recruitment at the beginning of the study and supervises the selection of the sites to be utilized for the study
- Develops the regulatory submission strategy for non-interventional studies and supervises the submissions in the different countries involved (for multi-country studies)
- Participates in investigator meetings and/or physician and site training sessions conducted via telephone and webcast conferences
- Supervises patient enrollment/registration, study data review, and query resolution efforts
- Plans and/or coordinates the on-site visits as required per study
- Reviews and approves monitoring visit reports and ensures tracking and resolution of ongoing site issues
- Liaises with Site Management Associates regarding start up, site management, data review, and query resolution issues providing guidance and suggestions for resolution
- Liaises with Clinical Research Associates regarding all site monitoring issues providing guidance and suggestions for issue resolution
- Interfaces with other project team members outside of clinical/site management to ensure that study milestones and outcomes are achieved
- Manages the operational budget and identifies out of scope tasks from the operational team with support from Project Manager and escalates as required
- Requests resources and forecasts resource needs for the operational team
- Operationalized and executes long-term site and patient retention plans, prescriber recruitment plans, and direct-patient follow-up plans developed in conjunction with project management and scientific affairs director(s), if applicable
- Collaborates with Biometrics in achieving successful delivery of data management deliverables, meeting internal and external client needs
- Provides day-to-day oversight of the clinical data review process during study conduct
- Reviews and provides input on data management plans for content and structure
- Helps ensure that applicable quality control steps are properly planned and completed
- May assume other data management activities as assigned
- Proactively identifies, resolves/mitigates and escalates risks and/or issues.
- Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.
- Spearheaded the selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
- Reduced operational costs through effective budget management, negotiation with vendors, and careful allocation of resources.
- Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
- Implemented risk management strategies, effectively minimizing potential threats to the success of clinical trials.
Clinical Research Manager
Harmony Clinical Research
North Miami Beach, FL
02.2016 - 01.2022
- Championed continuous improvement initiatives within the department, driving process enhancements that increased overall efficiency.
- Implemented quality control measures to minimize errors and improve the accuracy of study results.
- Leveraged industry trends and best practices to inform strategic decision-making within the organization.
- Coordinated efforts among investigators, sponsors, and regulatory agencies to ensure seamless execution of clinical trials.
- Streamlined document management processes to facilitate faster review cycles and reduce administrative workload.
- Increased patient enrollment in clinical trials by developing targeted recruitment strategies and outreach programs.
- Spearheaded interdepartmental collaboration for improved communication and resource sharing in clinical research projects.
- Enhanced clinical trial efficiency by streamlining data collection and analysis processes.
- Developed comprehensive budgets for clinical research projects, optimizing resource allocation and cost efficiency.
- Negotiated contracts with vendors, securing competitive pricing for critical study supplies and services.
- Collaborated with cross-functional teams to design innovative approaches to complex research challenges.
- Mentored junior staff members, providing guidance on best practices in clinical research management.
- Improved data reporting capabilities through the implementation of advanced software tools and analytics techniques.
- Demonstrated a commitment to ethical research conduct by ensuring adherence to regulatory guidelines and institutional policies.
- Fostered strong relationships with key stakeholders such as principal investigators, funding sources, and community partners.
- Evaluated the performance of individual studies against established benchmarks, identifying areas for potential improvement.
- Conducted thorough risk assessments for each project, implementing mitigation strategies where necessary to protect patient safety.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Managed multi-site clinical studies, ensuring timely completion and compliance with regulatory standards.
- Followed informed consent processes and maintained records.
- Gathered, processed, and shipped lab specimens.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Facilitated training sessions for study staff, enhancing their understanding of protocol requirements and procedures.
- Established effective monitoring systems to track progress and identify potential issues in ongoing clinical trials.
Certified Clinical Research Coordinator
Harmony Clinical Reseach
North Miami Beach, FL
02.2010 - 02.2016
- Gathered, processed, and shipped lab specimens
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets
- Maintained compliance with protocols covering patient care and clinical trial operations
- Collected data and followed research protocols, operations manuals and case report form requirements
- Coordinated clinical trials focused on disorders such as Diabetes, Hyperlipidemia, Hypertension, Depression, Anxiety, Obsessive Compulsive Disorder, Migraine, Crohn's Disease, Ulcerative Colitis, Motion Sickness, and many more
- Followed informed consent processes and maintained records
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies
- Extensive knowledge with EDC systems; Medidata Rave, Red Cap, Inform, Case link, Medrio, and many more
- Bilingual
- Ability to speak to English and Spanish speaking persons with fluency and understanding.
Education
Bachelor's - Psychology
Florida International University
Miami, FL05.2015
Associate - Psychology
Broward College
Fort Lauderdale, FL12.2013
Skills
- GCP Compliance Certified (10 years)
- SOCRA Certified (8 years)
- Electronic Data Capture Systems (10 years)
- Budget Management (10 years)
- Data Collection (10 years)
- EMR Systems (10 years)
- Quality Assurance (5 years)
- Employee Mentoring (10 years)
- Patient Care (10 years)
- Clinical Research (14 years)
- Team Management (6 years)
- Clinical Project Management (8 years)
- Medical Imaging (10 years)
- FDA regulations (10 years)
- Databases (10 years)
- Client Relations
- Stakeholder Communications
- Work flow planning
- Advanced problem solving
- Budgeting and forecasting
- Risk Management
- Vendor Management
- Cross-Functional Collaboration
- Bid Defense Meetings
- Team Bonding & Performance Improvements
Certification
- GCP Compliance, 01/01/25
- IATA
- SOCRA, 01/01/25
Personal Information
- Willing To Relocate: Anywhere
- Title: Project Manager
Work Authorization
Authorized to work in the US for any employer
Awards
Willis Holcombe Scholarship
Languages
English
Native or Bilingual
Spanish
Full Professional
Timeline
Project Manager
ICON plc
09.2023 - Current
Clinical Trial Manager
ICON Plc
01.2022 - 09.2023
Clinical Research Manager
Harmony Clinical Research
02.2016 - 01.2022
Certified Clinical Research Coordinator
Harmony Clinical Reseach
02.2010 - 02.2016
Bachelor's - Psychology
Florida International University
Associate - Psychology
Broward College