Project Manager Senior Clinical
Resume:
ELPINIKI NIKI PROTOPSALTIS
Novi, MI 48374
********@*****.***
EDUCATION
University of California, Berkeley
BS Genetics, May 1988
EXPERIENCE
IQVIA Biotech
Durham, NC
Senior Clinical Project Manager August 2024-December 2024
• Medical Device, Schizophrenia study
Compliance Task Force Lead June 2024-August 2024
• Audit and inspection readiness lead for a nephrology program. o TMF quality management.
o SOP compliance.
o Review and resolution of findings from audits and CAPAs. Senior Clinical Project Manager March 2023-June 2024
• Global Clinical Project Manager for a phase II randomized, double blind, placebo controlled hypothalamic obesity clinical trial in 5 countries with 15 investigational sites. o Oversight and leadership of global cross functional team using strong interpersonal skills to inspire team to meet start-up goals in a dynamic landscape due to change in sponsor, introduction of a protocol amendment, and changes in country and site mix mid start-up. o Feasibility and strategic planning to identify final country and site list. o Responsible for financial health, and leading departmental finance review calls. o Prepare and present at executive project review meetings. o Mentor and lead global project management team.
o Vendor Management and contracting:
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§ electronic connected devices, IP storage, shipment, and distribution, EDC, patient concierge services, and clinical site supplies.
§ Served as mediator to obtain fully executed three-way quality trial agreement, working with internal and external stakeholders including legal, QA, Clinical, and Project Management.
o Negotiated scope of work resulting in fully executed contract with sponsor adding 14M to originally proposed budget and scope of work within five months of fully executed Authorization to Proceed contract.
o Exceeded timelines for obtaining fully executed contract as well as receiving payment for up fronts, and two milestone payments prior to transition to new sponsor. o Negotiation of change order with sponsor to include additional scope of work and increased budget for electronic connected devices and medical monitoring. o Proactively identified and mitigated potential risks to optimize project performance realization, and utilization.
o Led and oversaw global cross functional team creation of presentation slides and created agenda for Client Take Off Meetings with both outgoing and incoming sponsor. o Manage activities related to transition to new sponsor including contracts, regulatory submissions, change in IND holder, and downstream effects on timelines. o Negotiate revised timelines and advise incoming sponsor on strategic planning with least impact on critical path to site activation and enrollment.
• Senior Clinical Project Manager for a phase II very rare genetic obesity clinical trial in 3 countries with 6 investigational sites.
o Manage global cross functional team ensuring quality of deliverables according to timelines and within budget.
o North America Project Manager
o Proactively identified and mitigated potential risks to optimize project performance realization, and utilization.
o Led and oversaw global cross functional team creation of presentation slides and created agenda for Client Alignment and Client Take Off Meetings. o Vendor management and contracting
o Manage forecasting, and OOS work ensuring financial health of study by obtaining monthly input from functional leads.
PPD
Wilmington, North Carolina
Associate Director Project Management November 2018-June 2020 3
§ Global Project Manager for PPD’s largest awarded program consisting of three phase III Ulcerative Colitis and three phase III Chron’s disease clinical trials in 39 countries with 420 investigational sites. o Oversight and leadership of global cross functional team using strong interpersonal skills to inspire team to exceed timelines.
o Directed regular program financial meetings with cross functional leads to review departmental realization and utilization ensuring adherence to program budget. o Successfully negotiated change orders totaling $45 million dollars in additional revenue to original $450M Scope of Work.
o Exceeded Site and Country activation goals in all 39 countries. o Negotiated vendor contracts in accordance with program deliverables and costs. o Directed all logistics of multiple international investigator meetings each with 100+ attendees reducing total cost compared to meetings of similar scale. o Renegotiated program budget with sponsor to accommodate rising cost of conducting clinical trials in Japan.
o Directed Japanese site budget negotiations with client resulting in successful opening of investigational sites in Japan.
o Represented the PPD Chron’s Disease Program and presented at national and international investigator meetings and conferences.
o Proactively identified and mitigated potential risks to optimize program performance realization, and utilization.
Senior Project Manager April 2017-November 2018
§ Regional Project Manager for North America, Latin America, and Japan for PPD’s largest international program consisting of three phase III Ulcerative Colitis and three phase III Chron’s disease clinical trials in 39 countries with 420 investigational sites.
o Credited with stabilization of Ulcerative Colitis and Chron’s Disease team by identifying and implementing solutions for critical program wide operational issues. o Directed approval process with PMDA to successfully gain PMDA approval and opening of the Ulcerative Colitis and Chron’s disease programs in Japan. o Vendor manager for 17+ program wide vendors successfully coordinating supply chain and budget constraints to activate sites ahead of timelines. o Exceeded site activation goals
Project Manager July 2015-April 2017
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§ Regional Project Manager for North America, Latin America, and Japan for program consisting of three phase III Ulcerative Colitis and three phase III Chron’s disease clinical trials in 39 countries with 420 investigational sites.
o Successfully negotiated new budget with client due to significant increase in cost from initial bid for conduct of phase III Ulcerative Colitis and phase III Chron’s disease program in Japan.
o Vendor Manager for phase III Ulcerative Colitis and phase III Chron’s disease global program.
§ Global Project Manager for phase II Ulcerative Colitis rescue program exceeding goals and timelines for successful transfer of program from former CRO as well as study site startup and patient recruitment.
§ Project Manager for phase III Lupus single country 23 site study.
§ Bid defense preparation and presentation winning newly awarded study. Quintiles
Durham, North Carolina
Clinical Project Manager April 2015-July 2015
Associate Clinical Project Manager August 2010-April 2015
§ Global and regional program manager for phase II and III clinical trials spanning several therapeutic areas. Managed timelines, scope of work, and project deliverables. o Successful negotiation of change orders totaling $4 million in additional revenue o Global Project Manager for phase III Polycystic Kidney Disease clinical trial in 22 countries with 236 investigational sites.
§ Successfully managed $56 million budget with 90% realization o Project Manager for phase III Rheumatoid Arthritis program
§ Successfully managed $28 million project budget including closeout activities for single country, 82 site clinical trial with 90% realization.
§ Successfully managed $54 million project budget including closeout activities for single country, 120 site clinical trial with 97% realization. o Rescued investigator payments from third party vendor with a two-fold increase in number of investigators paid on time.
o Vendor Manager
o Project Manager for unblinded portion of phase III Alzheimer’s clinical trial. 5
o Resolved client project audit findings including issues identified with Trial Master File for global Phase III Fabry’s disease trial which had been managed by multiple project managers previously.
o Directed close-out activities for global Phase III Fabry’s disease clinical trial including successful delivery of Trial Master File to client, and reconciliation of investigator payments.
o Created site visit report annotations, monitoring tools, and project guidelines to optimize CRA team performance.
o Trained and mentored project team members
Clinical Team Leader December 2007-August 2010
§ Directed and oversaw Clinical Team Leads across multiple programs o Managed scope of work and project deliverables
o Created guidelines and clinical monitoring tools to enhance performance and efficiency to exceed study project timelines and deliverables in line with scope of work. o Supported Clinical Team Leads with study start-up, enrollment, and close-out activities by providing oversight of program deliverables.
o Reviewed Site Visit Reports and identified and mitigated performance quality issues. o Identified and mitigated program quality issues through regular review of internal clinical and site communications, site visit reports, clinical data management, and conducting internal quality assurance audits.
o Directed clinical teams to improve efficiency and quality of assigned programs by conducting co-monitoring/accompanied site visits with CRA team. o Created site visit report annotations, study guidelines and monitoring tools for clinical teams.
o Oversaw clinical teams for adherence to site visit report annotations. o Escalated CRA report writing and SOP adherence issues to clinical and line management of the clinical teams for assigned programs.
o Decreased number of corrections to site monitoring visit reports by mentoring Clinical Research Associates on site visit report writing with adherence to site visit report annotations.
Associate Clinical Team Lead October 2007-December 2007
§ Clinical Team Lead for a phase II Cardiovascular clinical trial 6
o Managed Clinical Research associates in all aspects of study conduct including adherence to timelines and scope of work.
o Led weekly meetings with Clinical Research Associates o Responsible for creation and maintenance of the Trial Master File as well as management of Risk Issue Escalation Log.
o Developed and presented training materials to Clinical Research Associates Senior Clinical Research Associate 2006-2007
§ Senior Clinical Research Associate for clinical trials across multiple therapeutic areas that were complex and required advanced knowledge of therapeutic indications including a phase II Breast Cancer study. o Conducted regular investigational site visits and documented findings in site visit reports from study start-up to close-out to ensure investigational site adherence to protocol, Good Clinical Practices and FDA regulations.
o Mentored Clinical Research Associates
o Assisted Clinical Team Lead taking on additional tasks o Managed progress of assigned studies by
§ tracking regulatory submissions and approvals
§ mentoring site staff to enhance patient recruitment and enrollment and assisting with creation of patient recruitment advertising and tools.
§ Authored site action plans to mitigate investigational site quality issues
§ Generated queries and ensured timely resolution.
§ Conducted protocol training for site staff
Parke Davis (Pfizer)
Ann Arbor, Michigan
Senior Clinical Research Associate 1993-1997
§ Senior Clinical Research Associate for clinical trials across multiple therapeutic areas that were complex and required advanced knowledge of therapeutic indications including a phase III Hormone Replacement clinical trial, a phase II contraceptive clinical trial, and phase III Cardiovascular (Lipitor) clinical trial. o Conducted regular investigational site visits and documented findings in site visit reports from study start-up to close-out to ensure investigational site adherence to protocol, Good Clinical Practices and FDA regulations.
o Identified and assessed qualifications of clinical trial investigators o Authored and presented poster of study results for a phase III epilepsy study to investigators at medical meeting.
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o Prepared and presented clinical monitoring tools and case report forms at investigator meetings.
o Trained Clinical Research Associates and investigational site staff o Presented phase II contraceptive protocol and case report forms at investigator’s meeting. Clinical Research Associate 1991-1993
§ Clinical Team Lead for phase II contraceptive clinical trial. o Wrote protocol and worked with in-house team to design case report forms for a phase II contraceptive clinical trial.
§ Clinical Research Associate for phase II contraceptive and phase III Osteoporosis multicenter randomized clinical trials.
o Conducted regular investigational site visits and documented findings in site visit reports from study start-up to close-out to ensure investigational site adherence to protocol, Good Clinical Practices and FDA regulations.
o Identified and assessed qualifications of clinical trial investigators o Managed progress of assigned studies by
§ tracking regulatory submissions and approvals
§ mentoring site staff to enhance patient recruitment and enrollment and assisting with creation of patient recruitment advertising and tools.
§ Authored site action plans to mitigate investigational site quality issues
§ Generated queries and ensured timely resolution.
§ Conducted protocol training for site staff
Xoma
Berkeley, California
Clinical Research Associate 1989-1991
§ Clinical Research Associate for phase II and III bone marrow transplant and phase II colorectal cancer clinical trials.
o Conducted regular investigational site visits and documented findings in site visit reports from study start-up to close-out to ensure investigational site adherence to protocol, Good Clinical Practices and FDA regulations.
o Collaborated with principal investigator on research paper for phase III bone marrow transplant clinical trial.
o Identified and assessed qualifications of clinical trial investigators o Managed and disbursed investigator payments
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o Created Case Report Forms for assigned studies
o Managed progress of assigned studies by
§ tracking regulatory submissions and approvals
§ Generated queries and ensured timely resolution.
§ Conducted protocol training for site staff
§ Study Manager for phase II colorectal cancer study o Wrote protocol and worked with in-house team to design case report forms. o Presented protocol and case report forms at investigator’s meeting. AWARDS AND ACKNOWLEDGEMENTS
§ Received two additional bonuses and awards from the CEO of PPD for exceptional performance and dynamic leadership as Global Project Manager on Phase III Chron’s Disease program.
§ Received an off-cycle promotion to Global Project Manager due to exceptional performance.
§ Received acknowledgment from PPD and Sponsor for activation of countries and sites ahead of timelines on a Phase III Chron’s Disease program.
THERAPEUTIC AREA EXPERIENCE
Cardiovascular: Atherosclerosis, Aortic Thromboembolism Gastroenterology: Chron’s Disease, Ulcerative Colitis Hematology: Graft vs Host Disease, Bone Marrow Transplant Immunology: Lupus
Infectious Disease: Hep C, MRSA
Musculoskeletal: Rheumatoid Arthritis
Nervous System: Alzheimer’s Disease, Parkinson’s Disease, Epilepsy, Alcohol Dependence Nephrology: Polycystic Kidney Disease
Oncology: Breast, Colorectal, Hematologic Cancers
Rare Disease: Fabry’s Disease
Respiratory: COPD
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Miscellaneous: Hormone Replacement Therapy, Contraceptive CLINICAL TRIAL EXPERIENCE
Oncology: A Phase III Randomized, Placebo-Controlled Multi-Center Trial of Investigative Study Medication in the treatment of Graft vs Host Disease in patients with allogenic bone marrow transplant. A Phase II Randomized, Placebo-Controlled Multi-Center Trial of Investigative Study Medication in patients with colorectal cancer.
A Phase III Randomized, Comparative, Multi-Center study of Investigative Study Medication in patients with estrogen receptor positive breast cancer.
Women’s Health Studies: A Phase III Randomized, Placebo-Controlled Multi-Center Trial of Investigative Study Medication in patients with Osteoporosis.
A Phase III Randomized, Placebo-Controlled Multi-Center Trial of Investigative Transvaginal drug delivery system for Investigative Study Contraceptive.
Cardiovascular: A Phase II Randomized, Double-Blind, Multi-Center, Placebo-Controlled study to evaluate safety and efficacy of Investigative Study Medication in lowering cholesterol levels. A Phase III Comparative, Multi-Center, Compassionate Use Trial to evaluate safety and efficacy of Investigative Blood Product in Aortic Thromboembolism. Immunology: A Phase III Randomized, Placebo-Controlled Multi-Center Trial of Investigative Study Medication in treatment of patients with moderate to severe Rheumatoid Arthritis. A Phase III Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of Investigative Study Medication on Systemic Lupus Erythematosus Disease Activity. Nervous System: A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Evaluation of the efficacy and safety of Investigative Study Medication in the treatment of Epilepsy. A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled evaluation of the safety and efficacy of Investigative Study Medication in the treatment of Parkinson’s Disease. A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Cross Over Study evaluating safety and efficacy of Investigative Study Medication in treatment of Alcohol Dependence. A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study evaluating safety and efficacy of Investigative Study Medication in treatment of patients with Alzheimer’s disease. Respiratory: A Phase III Randomized, Placebo-Controlled, Multi-Center Trial of Investigative Study Medication in patients with COPD.
Nephrology: A Phase III Randomized, Placebo-Controlled, Multi-Center Trial to evaluate safety and efficacy of Investigative Study Medication in treatment of patients with Polycystic Kidney Disease. 10
Infectious Disease: A Phase III Randomized, Placebo-Controlled, Multi-Center Trial to evaluate safety and efficacy of Investigative Study Medication in treatment of patients with MRSA. A Phase III, Randomized, Placebo-Controlled Multi-Center Trial to evaluate safety and efficacy of Investigative Study Vaccine in treatment of patients with Hep-C. Rare Disorders: A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial evaluating safety and efficacy of Investigative Study Medication in treatment of patients with Fabry’s Disease. Gastroenterology: A Phase I B Observer-Blinded, Placebo-Controlled, Multiple Ascending Dose Escalation Trial to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of repeat intravenous administration of Investigative Study Medication in healthy volunteers and patients with Ulcerative Colitis. A Phase IIb Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial to investigate the safety and efficacy of Investigative Study Medication in patients with moderately to severely active Ulcerative Colitis.
A Phase II Extension Study of Investigative Study Medication in patients with moderately to severely active Ulcerative Colitis.
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of the effect of Investigative Study Medication on Systemic Lupus Erythematosus Disease activity. A Phase III Randomized, Double-Blind, Placebo-Controlled, Parallel-Group efficacy and safety trial of Investigative Study Medication as induction therapy in subjects with moderate to severe Ulcerative Colitis
(Figaro UC 301).
A Phase III, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group efficacy and safety trial of investigative study medication as induction therapy in subjects with moderate to severe Ulcerative Colitis
(Figaro UC 302).
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group efficacy and safety trial of investigative study medication as maintenance therapy in subjects with moderate to severe Ulcerative Colitis (Figaro UC 303).
A Phase III, Long Term Safety Extension trial in subjects with moderate to severe Ulcerative Colitis (Aida 304).
A Phase III, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group efficacy and safety trial of investigative study medication as induction therapy in subjects with moderate to severe Chron’s Disease
(Carmen CD 305).
A Phase III, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group efficacy and safety trial of investigative study medication as induction therapy in subjects with moderate to severe Chron’s Disease
(Carmen CD 306).
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group efficacy and safety trial of investigative study medication as maintenance therapy in subjects with moderate to severe Chron’s Disease (Carmen CD 307).
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