Project Manager Management

Biography

Jill Greeson has over eight years’ experience in various operations positions. Additionally, Jill has over twenty years of experience in pharmaceutical and health care environments. She has led over eleven oncology clinical studies in her career. Jill is a strong leader and influential communicator with a proven track record of driving performance and delivering results. Her expertise includes project management, vendor management, drug development studies, regulatory inspections, quality assurance, safety, trend analysis, leadership, radiology, and Six Sigma methodologies. All these experiences have culminated in Jill Greeson being an integral part of the clinical team bringing a broad background of knowledge and leadership expertise to accelerate operational delivery.

Her pharmaceutical experience has enabled her to work in all phases 1 through 4 of the global drug development process. She is a positive and enthusiastic team manager who is very passionate about her work in helping others. Her major accomplishments are FDA/EMEA IND approvals, Six Sigma yellow belt project to save $183K, and dissecting supply chain to save over $600K.

Professional Experience

Jun 2022- Dec 2023 Sun Pharma contract opportunity/ Princeton, NJ

Sr Clinical Project Manager

Project Leadership and Delivery for two global rescue studies Phases 1b and 2a:

-Single point of contact for both the USA and 8 European countries both overseeing the CRO, rescuing the study from the CRO, and taking over vendor management.

- Hire a team of contract CRA’s to take over the rescue studies using minimal FTE.

- Prepare/Update/Review of study plans and oversee compliance.

- Oversee recruitment of vendors to drive recruitment and meet predefined timelines.

- Identify underperforming sites and close swiftly to save expenses.

- Oversee and track regulatory as well as GCP compliance.

- Oversee maintenance and timely tracking of study information.

- Review and QC to ensure quality in the documents and the study.

- Manage the vendors for outsourced services to ensure timely setup conduct.

- Track their deliverables of the CRO and vendors against the contracts.

- Line Management, managing managers, and resources performing lead activities.

- Contribute to Clinical Development Strategy, training, and initiatives.

Mar 2021 – Jun 2022 Syneos Health/ Morrisville, NC

Sr Project Manager

- Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with GCPs, SOPs, and regulatory requirements for Phase 1a/1b and Phase 2.

- Acts as primary liaison between the company and the customer to ensure project launch, conduct, and closeout according to the customer’s contractual agreement.

- Leads clinical team to ensure quality, timelines, and budget management are within contract.

- Accountable for the financial performance as well as project deliverables of assigned projects.

- Coordinates activities, deliverables, proactively identify risks and issues.

- Accountable for the maintenance of project information on a variety of databases and systems.

- Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.

- Responsible for project management to always be inspection ready for all aspects of the project conduct that includes the TMF and CTMS.

- Provides oversight for development and implementation of project plans in accordance with SOPs.

- Independently prepares, coordinates, and presents project material at internal and external meetings.

- Directs the activities of assigned Project Support staff; line manager and mentors other project management team members and clinical staff; facilitates team building and communication.

- Prepares project management reports for clients and upper management.

- Implements resource strategies to achieve project goals.

- Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goals.

Dec 2018 - Mar 2021 PRA Health Science/ Raleigh, NC

Senior Study Manager and Clinical Scientist

Senior Study Manager on Assignment with Pfizer 03-03-2020 - 03-11-2021

- Lead Study manager of two global Oncology studies phase 3 and phases 1b/2a.

- Accountable for the development and approval of realistic detailed study startups and monitoring plans.

- Responsible for conducting country level feasibility in collaboration with Global Clinical Trial teams.

- Oversee the CRO, reviewing pre-trial assessment, approving sites, and approving site activation plans.

- Leads study risk and opportunities planning process in context of country, site, and subject.

- Supervise the CRO and vendors in tasks, milestones, and budgets to include invoice approval.

- Accountable for reviewing, negotiating, and confirming study work orders and change orders as well as, for the delivery of the study against approved plans.

- Leads inspection readiness activities related to study management and site readiness.

- Approves and oversees drug supply management by managing the flow of drug supply to the sites and setting up IRT with the Supply Chain Lead.

- Manage critical changes in financial forecast, scope adjustment, and deliverables.

- Ensures progression of Site Quality Events and resolutions.

- Volunteer to build the China HGRAC toolkit to save teams money and time for studies conducted in China.

Clinical Scientist in Oncology on Assignment with Merck 12-17-2018 - 02-21-2020

Performed Clinical Scientist tasks on four, phase 3, bladder oncology studies from mid-study to lock.

- Provides regular site status information to team and updates trial management tools.

- Leads medical monitoring meeting team in protocol deviations, radiology imaging issues, and escalating topics and trends identified to all colleagues.

- Collaborate with the medical writer in the development of protocol, amendments, and CSR.

- Lead’s the study in imaging, censoring reports, protocol milestones, primary clinical scientist contact.

- Monitors central lab reports and other external data for safety and critical values.

- Mentor new colleagues to learn the radiology process to decrease induction time.

- Volunteer to be the radiology subject matter expert and assist colleagues with overseeing their radiology clinical trial needs and questions.

- Volunteer to write the team newsletter to keep the sites informed of the study and identify trends.

Jul 2017 - Dec 2018 Celerion/ Lincoln, NE

Clinical Program Director

Successfully performed multiple roles in oncology, infectious disease, dermatology and central nervous system. Lead the department in bid defense meeting, feasibility, site budgets, study conduct, closeout, and final reports. The line manager for nine colleagues.

- Performed project lead activities; from project proposal and budget (pre-contract) to study closure within budget and quality standards for phase 1a, 1b, and phase 2.

- Managed study teams and sponsor for adherence to GCP, regulatory requirements, and timelines.

- High-end clinical project management (budget, resources, compliance, decision-making level) and managing multiple projects and studies.

Sep 2007 - May 2017 Pfizer (formerly Wyeth)/ Collegeville, PA / Durham, NC

Associate Director, Lead Clinician

Served as Lead Clinician on two pediatric opioids teams. Worked on worldwide Women’s Health, Alzheimer’s, Vaccines, and Rare Diseases in phases 2, 3, and 4 for project execution. Monitored studies for safety, trends, and timelines. Wrote narratives, protocols, clinical study report, summary of clinical safety, integrated summary of safety, integrated data review plan, consent, and assent forms.

- Oversaw the IND submission of FDA/EMEA, regulatory inspections and approval of Troxyca, Duavive, Duavee, and Conbriza.

- Launched Yellow Belt Six Sigma project with DMAIC that increased productivity of 109 colleagues resulting in saving of $183,000.

- Served as subject matter expert for SOP Global Standards for Interventional Studies and CAPA for Management of Compassionate Access Request.

- Saved $600K in drugs that were planned for destruction by dissecting supply chain spreadsheets.

- Accelerated operational delivery across projects by three months by using lessons learned.

Therapeutic Experience

Analgesia

Pain, Chronic

Cardiovascular

A Atherosclerosis

Endocrinology

R Rare Disease Acromegaly, Short Stature

In Infectious Disease

H HPV, Rare Disease Zika Virus

Immunology/Inflammatory

L Lupus Nephritis

Nephrology

R Rare Disease C3G Kidney Disease

N Neurology

Al Alzheimer’s Disease

Oncology

R Rare Disease CML, Advanced Solid Malignancies, Bladder, Hematologic H Malignancies, Hepatocellular, Metastatic Solid Tumors, Pancreatic

Skeletal Disease

O Osteoporosis, Postmenopausal

Women’s Health

U Uterine Fibroids

Professional Certifications & Licensures

- Yellow Belt

- Radiologic Technologist

Education

- Immaculata University, United States, Masters – Arts- Organizational Leadership

- Gwynedd Mercy University, United States, Bachelor –Health Science –Education

- Pennsylvania State University, United States, Associate – Science - Radiology

Professional Affiliations

- American Society of Radiologic Technologists - Radiographer and Magnetic Resonance Technologist

- The American Registry of Radiologic Technologists - Radiographer and Magnetic Resonance Technologist

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