Jennifer (Jenny) Palmer
Summary
Accomplished clinical operations manager with comprehensive experience in project oversight and regulatory compliance. Skilled in leading teams through all phases of clinical studies while optimizing processes and resource allocation. Strong ability to communicate and collaborate effectively with internal and external stakeholders to ensure project success.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Executive | Clinical Operations Manager II
CPC
Aurora
11.2023 - Current
- Oversee clinical operations management activities to ensure alignment with project timelines and regulatory compliance on both Sponsor side, and leading ARO side.
- Manage site identification, evaluation, initiation, contracting, budget negotiation, and monitoring processes.
- Operationalized Phase III complex global studies
- Provided input and managed review cycles of protocol creation and protocol amendments both for US and ROW implementation
- Identify required regulatory documents for investigational product release and oversaw collection.
- Prepare central IRB submissions and ensured collection of all new or expiring investigator regulatory documents.
- Developed project-specific essential documents for site oversight and site materials.
- Reviewed and finalized monitoring visit reports and follow-up letters with clinical research associates (CRAs).
- Collaborated with CRAs on site management to identify and resolve compliance issues.
- Tracked and approved vendor payments, managing contracts for clinical services to maintain budget adherence.
- Manage all monthly, annual, and ad hoc FDA IND submissions as Sponsor representative
- Provide feedback to ARO/CRO partners as the sponsor stakeholder
- Lead and manage senior leadership meetings both from sponsor perspective and leading ARO prospective
- Authored study plans and manuals per operationalizing the protocol
- Oversee ROW regulatory submissions including countries in EU, APAC, UK, North America & LATAM
- Managed ROW regulatory RFIs
- Selected and worked with National Lead Investigators
- Operationalized adjudication processes along with database builds
- Operationalized protocol activities including EDC and IRT builds with CRF creation
- Assisted the TFL creations to identity gaps in data, and used those gaps to implement changes in site workflow
- Mentored research assistants, CTMs, and junior COMs
- Identified risks in operational workflows and drove strategic conversations to minimize risk
- Review data metrics to identify potential timeline delays and presented data during strategic meetings
Manager, Project Management
Summit Clinical Research
San Antonio
05.2024 - 11.2024
- Provided direct oversight to 17 project managers, clinical trial assistants, and program managers.
- Conducted performance reviews and facilitated regular check-in meetings to enhance team engagement and development.
- Attended client calls as escalation point for CRO and sponsor inquiries.
- Led executive leadership calls with clients and internal management to discuss project status.
- Managed operations department budgets, ensuring alignment with project goals and financial objectives.
- Quality checked monthly financial deliverables from project management team, ensuring milestone achievements.
- Supported site start-up activities and prepared documentation for IRB submission, ensuring compliance with regulatory requirements.
- Ensured compliance with study protocols, SOPs, and ICH/GCP regulations throughout study lifecycle.
Clinical Operations Manager I
CPC
Aurora
07.2024 - 05.2024
- Streamlined site identification and evaluation to enhance project selection process.
- Developed and reviewed essential study documents, including protocols and management plans.
- Ensured compliance of site regulatory documents with CPC SOPs and applicable regulations.
- Prepared central IRB submissions while addressing any arising IRB issues.
- Managed site enrollment, subject tracking, and payment processes efficiently.
- Coordinated monitoring of project deliverables and timelines to maintain schedule adherence.
- Developed and distributed comprehensive project documents, such as safety and monitoring reports.
- Identified specific training needs for team members, ensuring timely completion of documentation.
CLINICAL PROJECT MANAGER I
CUREBASE
Phoenix
03.2022 - 03.2023
- Led cross-functional study teams across clinical services, data management, biostatistics, and pharmacovigilance.
- Developed and executed project plans aligned with protocols, SOPs, and ICH-GCP to meet regulatory standards and study objectives.
- Managed operational aspects of clinical studies, ensuring adherence to timelines, budgets, and resource allocation while overseeing vendor performance.
- Directed study startup efforts such as trial master file setup, site selection, initiation, and budget negotiations.
- Identified study risks and issues, creating mitigation strategies and CAPA plans to address challenges and ensure project continuity.
- Ensured quality execution of activities by external service providers per established contracts.
- Served as primary contact for study sponsors, facilitating effective communication and conducting regular meetings.
- Maintained trial master file filing and archival procedures according to SOPs.
CLINICAL TRIAL DEPLOYMENT PROJECT MANAGER
CARE ACCESS RESEARCH
Phoenix
01.2022 - 03.2022
- Managed vaccine/immunology trials in Phase 3, ensuring alignment with operational goals.
- Conducted strategic capacity planning for upcoming trials, including Alzheimer’s Phase 3 and CVD Phase 0.
- Developed systems and processes that streamlined deployment through efficient site orchestration workflow.
- Led meetings with internal and external stakeholders to facilitate successful site deployments.
- Coordinated interdepartmental communication for scheduling and planning of site activities, enhancing collaboration.
- Staffed decentralized clinical trial sites per protocol’s SOA to ensure operational readiness.
PROJECT SPECIALIST
SYNEOS HEALTH
Phoenix
06.2021 - 01.2022
- Collaborated with senior directors and team leads on special project initiatives.
- Established and maintained project files across multiple databases, ensuring regulatory compliance and facilitating project tracking.
- Prepared and distributed meeting minutes and action items, enhancing accountability for internal and external meetings.
- Followed up on action items with team members to ensure timely closure.
- Maintained communication among team members and site staff, promoting transparency regarding project status.
- Archived all study documents in accordance with established guidelines and policies.
- Supported quality assurance activities by preparing documentation for audits and internal reviews.
TRANSITION PROJECT MANAGER
Tenet Healthcare Corp/Abrazo
Phoenix
09.2019 - 06.2021
- Oversaw 15-20 concurrent projects, ensuring timely completion and quality results.
- Streamlined communication with providers during project processes to ensure alignment.
- Conducted weekly transition calls to provide status updates for ongoing projects.
- Participated in daily national and market-wide conference calls for project updates.
- Managed service lines focused on cardiology, neurology, and weight management, while tracking orthopedics, family practice, and surgery to support team efforts.
- Partnered with team members to clarify project requirements and develop effective solutions.
- Built strong vendor relationships to improve service delivery.
- Performed site evaluations, customer surveys, and team audits to assess performance.
CLINIC MANAGER
Louisiana Family Medicine Clinic
Bossier City
04.2018 - 06.2019
- Managed departments within clinic, including front office, radiology, lab, and clinical staff.
- Oversaw staff scheduling and maintained optimal staffing levels.
- Managed daily clinic operations and ensured efficient workflow.
- Coordinated patient care processes, improving service delivery and patient satisfaction.
- Developed and implemented clinic policies and procedures.
- Supervised training programs for new employees and ongoing staff development.
- Monitored compliance with healthcare regulations and standards to ensure clinic accreditation.
- Facilitated communication between medical staff and administrative teams, streamlining operations and enhancing collaboration.
- Evaluated clinic performance metrics to identify improvement areas.
- Conducted chart audits to ensure compliance with quality standards.
- Educated staff on implementation of protocols and procedures for enhanced efficiency.
- Aligned daily operations with patient needs through feedback analysis and continuous improvement plans.
- Recruited and hired skilled clinical and administrative staff to enhance team capabilities.
- Resolved conflicts among physicians, nurses, and healthcare staff to maintain workflow continuity.
PATIENT CARE/ INTAKE COORDINATOR
The Wall Center for Plastic Surgery
Shreveport
09.2015 - 04.2017
- Answered inquiries about practice services and screened potential patients for eligibility to ensure appropriate surgical placements.
- Interviewed patients to gather medical information and insurance details.
- Educated potential patients on surgical options and provided surgical packets to facilitate informed decision-making.
- Assisted patients through surgical processes and supported clinical rotations.
- Conducted surgery tracking to verify matrices, improving accuracy of patient scheduling and resource allocation.
- Compiled physical and digital documentation, including charts, reports, and correspondence.
- Developed office procedures with updated SOPs to train administrative support staff.
PATIENT CARE TECHNICIAN
North Fulton Hospital
Roswell
01.2015 - 08.2015
- Delivered direct patient care by monitoring vital signs and performing accuchecks to ensure patient stability.
- Inserted and removed catheters while conducting bladder scans and IV removals.
- Collaborated with surgical, med/tele ICU, neuro ICU, and rehab units to fulfill unit-specific requirements and enhance patient outcomes.
- Maintained accurate medical records through careful observation and documentation of baseline measurements to support effective patient management.
- Utilized aseptic technique for cleaning and sanitizing rooms and equipment to prevent infection.
- Responded promptly to patient alarms and needs-assessment requests to determine appropriate care actions.
- Communicated effectively with patients, families, staff, and other hospital departments to enhance service quality.
Education
Master of Healthcare Administration -
Louisiana State University
Shreveport, LA05-2018
Bachelor of Science - Psychology
Kennesaw State University
Kennesaw, GA05-2015
Skills
- Clinical operations management
- Clinical research management
- Clinical research design
- Clinical research regulations
- Clinical research studies
- Clinical Research Conduct
- Project management
- Project documentation
- Vendor management
- Risk management
- Risk assessment
- Quality mitigation
- CAPAs
- Clinical metrics evaluation
- Stakeholder engagement
- Stakeholder presentations
- Site evaluation
- Regulatory compliance
- Healthcare
- Project multitasking
- Strategic problem solving
- Strategic planning
- Change implementation
- Leadership
- Team leadership
- Cross-functional collaboration
- Time management
- Prioritization
- Organization
- Clinical staff training
- Clinical research design
- Clinical research training
- Clinical research management
Training
- ORAQ Regulatory Affairs Training Program (IND & IDE), Duke University, 11/24/24
- Clinical Project Manager Certificate, Barnett International, 01/23/23
- Clinical Research Fastrack Certificate, 05/20/20
Certification
- Clinical Project Manager
- ORAQ Regulatory Affairs
Timeline
Clinical Operations Manager I
CPC
07.2024 - 05.2024
Manager, Project Management
Summit Clinical Research
05.2024 - 11.2024
Executive | Clinical Operations Manager II
CPC
11.2023 - Current
CLINICAL PROJECT MANAGER I
CUREBASE
03.2022 - 03.2023
CLINICAL TRIAL DEPLOYMENT PROJECT MANAGER
CARE ACCESS RESEARCH
01.2022 - 03.2022
PROJECT SPECIALIST
SYNEOS HEALTH
06.2021 - 01.2022
TRANSITION PROJECT MANAGER
Tenet Healthcare Corp/Abrazo
09.2019 - 06.2021
CLINIC MANAGER
Louisiana Family Medicine Clinic
04.2018 - 06.2019
PATIENT CARE/ INTAKE COORDINATOR
The Wall Center for Plastic Surgery
09.2015 - 04.2017
PATIENT CARE TECHNICIAN
North Fulton Hospital
01.2015 - 08.2015
Master of Healthcare Administration -
Louisiana State University
Bachelor of Science - Psychology
Kennesaw State University