Project Manager Management

SUMMARY

Pharma and biotech professional with ** years of project management experience. Early Phase, Exploratory, First in Human (FIH), and Clinical Pharmacology Studies; Phases I, II, III, IV; as well as Feasibility, Observational, Unblinded studies, Investigator-Sponsored Trials (IST) and Early Access Trials. Works closely with relevant departments including medical writing, biostatistics, data management, pharmacovigilance and regulatory to ensure the successful management of clinical trials.

COMPETENCIES

CRO Management – Direct Reports – Study Start-up – Clinical Trial Agreement (CTA) –Protocol and Amendment Writing – ICF Development – Clinical Study Report (CSR) Writing – Line Listing (Data) Review – Database Lock (DBL) – Safety Data Review – eCRF Design – User Acceptance Testing (UAT) – Site Monitoring (CRA) – Training – Study Manuals – Negotiation – Adjudication – EDC – eTMF/Veeva Vault – MS Office Software (Word, Excel, Outlook, PowerPoint)

Autoimmune Cutaneous Lupus Erythematosus (CLE) – Rheumatoid Arthritis – Nephritis

Dermatology Atopic Dermatitis – Plaque Psoriasis Device – No specific TA Gastroenterology Crohn’s Disease (adult and pediatric)m– Ulcerative Colitis Hematology/Oncology Chronic Myeloid Leukemia (CML) – Chronic Lymphocytic Leukemia (CLL) – Multiple Myeloma (MM) Infectious Diseases Complicated Bacterial Skin and Soft Tissue Infections – HIV and AIDS – Sinusitis – West Nile Vaccine Metabolic Disease Diabetes Musculoskeletal Diseases Bone Growth Factor (efficacy with dental implants) – Gout Refractory Neurology Migraine – Pain (adult and pediatric) – Post-op pain (bunionectomy) – Amyotrophic Lateral Sclerosis (ALS) – Multiple Sclerosis (MS) Oncology Breast Cancer Ophthalmology – Anterior Uveitis, Posterior Uveitis, and Panuveitis – Active Chronic Non-infectious Uveitis (CNIU) – Corneal Endothelial Dystrophies (CEDs) and Low Corneal Endothelial Cell (CEC) Counts Pulmonology Pulmonary Hypertension – Mycobacterium Avium Complex (MAC) Psychiatric Disease Pediatric Bi-Polar Renal Disease IgA Nephropathy

PROFESSIONAL EXPERIENCE

EDETEK, Inc. Oct 2024 – April 2025

(Contract) Senior Project Manager

Oversaw and coordinated clinical trial projects in ophthalmology, progressing desmoid tumors, plaque psoriasis, ulcerative colitis, and Crohn’s Disease. Worked closely with cross-functional teams internationally including biostatisticians, statistical programmers, data managers, clients, and vendors to ensure delivery of high-quality output. Managed assigned projects, while leading and motivating the assigned project team, facilitating the team’s ability to fulfill their responsibilities. Trained DM personnel in project management duties. Responsibilities encompassed: Project Planning and Management; Team Coordination; Risk Management; Client and Stakeholder Management; training, as well as Resource Management.

Syneos Health Aug 2022 – Dec 2022

(Contract) Senior Project Manager

Directed start-up of two large Global Phase III studies for indication of IgA Nephropathy with studies run in North America, Europe, South America, and Japan. Planned and conducted Investigator Meetings; trained CRAs; managed vendors; wrote protocol amendments; developed ICF templates and reviewed site specific ICFs; developed all manuals pertaining to the successful start-up of the studies.

Eli Lilly and Company May 2021 – Aug 2022 (Contract) Clinical Trial Project Manager – Early Phase

Led study teams of internal and external partners in the planning and execution of Early Phase and Clinical Pharmacology studies in multiple therapeutic areas: Atopic Dermatitis; Breast Cancer; Device; Diabetes; Immunology; and Pulmonary Hypertension including study start-up and close-out. Planned and executed study management activities including timeline, risk management, and development of training materials. Interacted closely with the investigative sites. Identified and communicated the status of ongoing projects, issues, and risks that might affect the impact on supply chain of the study and project schedule. Reviewed monitoring reports and ensured resolution/follow-up of data queries and monitoring issues. Escalated unresolved quality and/or performance issues as necessary. Ensured study-level safety review was planned and performed. Answered protocol and technical questions from business partners.

Insmed Incorporated Jan 2021 – Apr 2021 (Contract) Associate Director, Clinical Operations

Provided operational oversight for a clinical pharmacology program for Phase I studies of a compound being developed to treat various lung diseases with a focus on study start-up. Compressed timeline for study start-up from 6 months to 4 months. Led selection of vendors and later managed vendors (CROs, central, biomarker, and specialty laboratories) including review of contracts/work orders. Developed CTAs. Mentored junior team members. Reviewed metrics and Key Performance Indicators. Managed clinical program budgets and execution of program timelines. Took part in kick-off meetings, monitoring training, and various CRO and other vendor meetings. Contributed to the development of protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials. Presented trial status and clinical operations strategy to project team and management. Reviewed and approved specific study documents (ICFs, study guides, operations manuals, training materials). Approved action plans to address protocol compliance, safety, data, and administrative issues with investigational sites and CROs. Main responsibility was for. Assisted with other studies as needed including a Phase IV Mycobacterium Avium Complex trial.

Medical Research Network Ltd Aug 2020 – Nov 2020

(Contract) Project Manager

Directed all start-up activities for Phase III Gout Refractory Disease and Phase III pediatric Crohn’s Disease studies. Developed study plans for both projects to include assessment of potential risks to the project delivery including contingency plan. Planned nurse training and execution of support documents to assist the Clinical Team and Nurse Manager. Created and produced site support documents and Communication Plan. Ran sponsor client meetings including agenda development and minutes. Tracked issues on study log and ensured appropriate dissemination of information to relevant departments.

Trial Runners, Inc. Jan 2020 – June 2020

Project Manager

Collaborated with sponsor to oversee Phase I/II, Phase 2B/III, and Observational ophthalmology clinical studies to ensure studies remained within scope and that any out-of-scope activities were identified and managed as appropriate. Oversaw all aspects of study start-up including feasibility. Performed risk management and contingency planning activities to ensure that all potential study risks were managed in a proactive manner. Developed and monitored project timelines and resources allocated. Communicated up-to-date information regarding project progress to all relevant parties including presentations to upper management. Provided strategic input on enrollment and contingency planning. Vendor management to include procurement and negotiation of contracts. Led internal project team meetings and sponsor meetings. Assisted in protocol development and CRF design. Managed clinical study budget and contracts. Oversight of direct reports (Project Assistant and Clinical Research Assistant).

Multiple Myeloma Research Foundation Aug 2018 – Aug 2019

Clinical Trial Project Manager

Provided direct oversight of start-up activities for a Phase I/II study of novel treatment combinations for relapsed refractory Multiple Myeloma including: protocol writing; ICF template writing; completion of relevant documents for IND submission; CRO selection; development of pharma partner budget, site budgets, and CTAs. The protocol received FDA approval as the second study for which MMRF holds the IND. Provided support for start-up on the first study for which MMRF holds the IND including: ICF template writing; protocol editing; development of registration documents; development of ophthalmologic source documents; review/approval of plans drafted by CRO; review/approval of eCRFs; and UAT testing. Accountable for oversight of a dozen Investigator Sponsored Trials (ISTs) for varying subcategories of Multiple Myeloma. Accountable for: site payments and invoice approval; milestone invoicing to pharma partners; site budget negotiations; communication between study centers and pharma partners.

Lotus Clinical Research, LLC. Jul 2017 – Mar 2018

Senior Project Manager

Provided oversight for a Phase II post-op pain study (bunionectomy) as well as support in the form of Unblinded Project Management for two Phase III post-op pain studies (bunionectomy). As unblinded PM, I had responsibility for the unblinded CRAs which included: assurance with compliance to unblinded monitoring responsibilities; review of Pharmacy Monitoring Reports and providing feedback; and ensuring that pharmacy monitoring visits were scheduled appropriately. Oversaw all aspects regarding investigational product (packaging, inventory, consulting with IVRS vendor). As PM for the Phase II study, I oversaw all aspects of the trial including CRA activities, vendor management, protocol amendment writing, ICF development, and development of all study manuals. Additionally, after the start of the study it was deemed necessary to implement an Unblinded Data Monitoring Committee for which I drafted the associated charter document. Primary contact for Sponsor companies and secondary contact for investigational sites.

SBC Consulting Feb 2015 – Feb 2017

(Ce3 Inc. and Avillion LLP)

Ce3:

Senior Project Manager

Provided oversight and guidance in support of two Phase II Oncology studies. Primary contact for Sponsor companies and secondary contact for investigational sites. Provided project/trial level input and coordination, including feasibility analysis, recruitment projections, data collection status, data cleaning progress and strategy, data lock tracking and overall reporting of deliverable timelines. Teamed with the Sponsor Study Manager and Data Management partner in the development and review of the data management plan, edit specifications, CRF development and completion instructions, diaries, questionnaires, and data screens (if EDC). Developed Site Initiation presentations. Also, assisted other PMs with Profile Reviews and TMF QC in preparation of a sponsor audit.

Avillion:

(Contract) Clinical Project Manager

Reported directly into the Head of Clinical Operations in support of a Global Phase III Oncology study. Provided oversight and guidance to the CRO and other vendors. Reengaged the CRO team that had become disengaged due to strained relations with my predecessor. This is turn resulted in the North America region going from grossly behind to the first region to meet enrolment goals. Additionally, repaired relationship resulted in my regions achieving interim data cleaning and data base lock ahead of all other regions. Main responsibilities were successful planning, implementation, and delivery of the trial with project teams located in North America and Latin America. Engaged clinical research sites to optimise both quality and recruitment by utilizing face-to-face meetings with individual Principal Investigators and associated study staff. Additional responsibilities included: prepare and present at site meetings, investigator/monitor meetings and governance boards.

PPD, Inc. Oct 2012 – Jan 2015

Senior Project Manager, Global Project Management

Oversaw start-up through final project products of multi-centre global outpatient studies, Phases I-IV primarily in HIV infection indication, with project teams located in North America, Eastern and Western Europe, Latin America, and Asia Pacific regions. Primary Sponsor contact. Analysed and oversaw cost, personnel hours and project needs to complete projects within budget while adhering to the contract. Facilitated vendor and site agreements; oversaw rollout of the vendor’s web-based system; accountable for metrics maintenance. Additionally, oversaw various data deliverables and vendor management as part of a blinded team and oversaw IP and ancillary supplies as an un-blinded team member for a global phase III comparative trial in complicated bacterial skin and soft tissue infections.

Purdue Pharma L.P. Jul 2011 – Jan 2012

(Contract) Clinical Study Manager

Safeguarded clinical study quality and consistency of team performance for assigned studies of Phase I and Phase III pediatric and adult pain. Ensured overall timeline adherence and performance against the clinical study plan; organized and facilitated the overall planning, coordination, tracking and general performance of clinical studies in support of the Clinical Development Plan; peer management; coordination of CROs, contractors and other Purdue colleagues to ensure adequate resource volume and quality was maintained on assigned studies; protocol review including advising team regarding logistics involved in the conduct of the protocol(s); ICF development and review; study start up; assisted with Drug Safety Process set up and follow-through for assigned studies; oversaw investigational product/comparator supply requirements (Schedules II and III) plus accountability for assigned projects; generated Bulk Supply Orders and Clinical Supply Orders.

Boehringer-Ingelheim Pharmaceuticals, Inc. Aug 2009 – June 2011

(Contract) Local Clinical Monitor (Project Manager)

Oversaw planning, conduct, and completion of operational activities for several global clinical trials in a Phase III program for Type 2 Diabetes Mellitus. Included study start up activities and CRO/vendor oversight. Developed the interim and final Clinical Trial Reports for a pivotal study of Investigational Product [authoring of appendices; coordination of the medical writing process, authoring / editing patient narratives]; prepared, reviewed and transmitted required adjudication materials for a pivotal trial including: direct communication with Clinical Event Committee (CEC) members and members of the DM team to ensure that adjudication cases were completed, queries were addressed by the CEC and data was entered into the database in a timely fashion, negotiation / finalization of consultants’ agreements for Data Monitoring Committee Oversight Board members and coordinated Clinical Event Committee with DM team for adjudication; review / approval of patient and site Newsletters; maintained an active liaison with members of other internal departments involved in the drug development process (Data Management, Regulatory Affairs, Drug Safety, Medical Controlling, Clinical Trial Supply Unit and Clinical Field Operations). Reviewed ~400 patient narratives in preparation for submission to FDA of a registrational trial.

PRA International, Inc. Oct 2006 – Aug 2009

Senior Clinical Project Manager

Communicated project status to Sponsor and internal departments for Phases I-III in multiple therapeutic areas including Ophthalmology, Migraine, Paediatric Bi-Polar Disease, and Vaccine (West Nile). Primary contact for communication between PRA project team and Sponsors as well as associated vendors. Developed and implemented the program plan, protocol, project plan, and determined resource requirements. Coordinated and managed all aspects of clinical trials across relevant departments (study start up, safety, data management, statistics, finance). Ensured on time delivery of projects, within budget, and according to requirements and expectations.

ICON Clinical Research, Inc. Sep 2002 – May 2006

Clinical Project Manager

Coordinated and managed all aspects of clinical trials (Feasibility, Phase I in Amyotrophic Lateral Sclerosis, Phase II in Cutaneous Lupus Erythematosus, and Early Access Program for indication of HIV) across relevant departments (safety, data management, statistics, and finance). Primary contact between contracted departments and Sponsor. Provided performance evaluation feedback to assigned staff. Developed and generated study tracking reports. Interpreted the findings of these reports and recommended and implemented appropriate follow up actions. Conducted oversight of start-up activities.

Alexion Pharmaceuticals, Inc. Oct 2000 – Aug 2002

Clinical Project Leader

Managed all aspects of domestic and international clinical trials for assigned studies of Phase IIb-III Nephritis and Rheumatoid Arthritis. Wrote protocols and protocol amendments; and coordinated approvals with medical experts, statisticians, and regulatory consultants. Selected contract services including central laboratory, central radiology, interactive voice-response (IVRS) randomization and drug distribution services. Conducted study start-up activities including ICF review; designed and formatted eCRFs and developed eCRF completion guidelines. Developed Company SOPs in coordination with the regulatory group.

Bayer Corporation Apr 2000 – Sep 2000

(Contract) Clinical Safety Specialist

Reported Drug Safety information on investigational and marketed drugs from both domestic and international sources. Managed the collection, review, and distribution of information on alert term and serious adverse events (SAEs) for an 18,000 patient post-marketing study for the indication of sinusitis. Readied Med Watch reports for FDA submission.

Abt Associates Clinical Trials Mar 1999 – Nov 1999

Manager, Regional Clinical Research Associates

Provided support and professional development to 17 regional CRAs including training. Managed activities of CRAs in all areas of clinical trials conduct including: maintenance of regulatory documentation; adverse event reporting; adherence to GCPs and SOPs; and writing of monitoring reports and site correspondence. Provided interim Project Management support for several key studies.

Clinimetrics Research Associates, Inc. Sep 1996 – Dec 1998

Clinical Research Associate

Conducted qualification, initiation, interim and close-out monitoring visits for Phase I-IV clinical trials in Type 2 Diabetes, Bone Growth Factor (efficacy with Dental Implants), Erectile Dysfunction, and Multiple Sclerosis. Interacted with Sponsors, sites, and internal colleagues to ensure effective project management; protocol and protocol amendment writing/development. Performed study start up activities.

Bristol-Myers Squibb Company July 1990 – Sep 1996

Clinical Scientist and Associate Clinical Scientist

Project coordination; site management/assurance by conduct of qualification, initiation, interim and close-out monitoring visits for Phase I-III and post-approval clinical trials in AIDS indication. Oversight of CRO monitors for pivotal NDA study. Developed CRFs, CRF completion guidelines, and annotated CRFs. Performed all aspects of study start up activities including budget negotiations and grant payments. Wrote/developed protocols and amendments plus report writing (including IND Safety Reports). Assisted with NDA submission for stavudine / Zerit® (first drug to garner fast-track approval from FDA).

EDUCATION

Master of Public Health (MPH), Epidemiology

Graduate School of Health Sciences, New York Medical College, Valhalla, NY

Bachelor of Science (BS), Psychology

State University College, Oneonta, NY

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