Clinical Research Site Manager

*

HAROLD H. OLIEBERG, MBA, BSc, CRCP

**** ***** ********** **., *****, FL 33619

Email: **************@*****.***

Phone: 813-***-****

SUMMARY

• Experienced Clinical Research Site Manager/Sr. Clinical Research Associate, with a demonstrated history of Managing Clinical Research Sites. Skilled in training of site staff, facilitate clinical studies start-up and conduct, possess extended knowledge of Good Clinical Practice (ICH-GCP), Regulatory/Essential Documents review, use of Electronic Data Capture Systems (EDC), Prepare and Execute Clinical Trials Agreements (CTA), Use of Clinical Trials Management Systems (CTMS), Navigate Institutional Review Board (IRB) Portals. Poses Excellent Communication skills and experience in applying electronic and time management tools to meet project and reporting timelines. Professional Experience

Axsome Therapeutics, Inc (Dec 22 – Feb 24)

Sr. Clinical Research Site Manager (Contract)

Indications: Alzheimer’s Disease and Major Depressive Disorders (MDD) Responsibilities/Tasks:

• Conducted all activities with regards to Site Management (e.g., site selection, start-up, staff training, study Initiation, Monitoring and Study Close-Out)

• Provided training activities based on study protocol, procedures, and applicable regulatory guidelines.

• Functioned as liaison between study Sponsor/CRO and investigational sites.

• Collected Regulatory/Essential Documents for Trial Master Files

• Managed Vendors/Providers of Central-Labs services, Rating Scales, and Investigational product.

Worldwide Clinical (April 21 to Nov 23)

Sr. Clinical Research Site Manager (Contract)

Indications: Alzheimer’s Disease and Cardiovascular Responsibilities/Tasks:

• Conducted all activities with regards to Site Management (e.g., site selection and start-up, Essential Documents review and collection, Initiation, monitoring and close out)

• Provided training activities based on study protocol, procedures, and applicable regulatory guidelines.

• Functioned as liaison between study sponsor and investigation sites.

• Collected Regulatory/Essential Documents for Trial Master Files 2

Zoll, Inc., (Mar 2019 – April 21)

Sr. Clinical Research Associate (Contract)

Indications:

• Heart Failure Optimization Clinical Study.

• Benefits of Micro-Cor in Ambulatory Decompensated Heart Failure (BMAD-HF-Study)

• Benefits of Micro-Cor in Ambulatory Decompensated Heart Failure (BMAD-Treatment) study

Responsibilities/Tasks:

• Conducted all activities with regards to Site Management (e.g., site selection and start-up, Essential Documents review and collection, Initiation, monitoring and close out)

• Provided training activities based on study protocol, procedures, and applicable regulatory guidelines.

• Functioned as liaison between study sponsor and investigation site.

• Collected Regulatory/Essential Documents for Trial Master Files

.

OneBlood, Donation Center, St Petersburg, FL (Feb 2017 – Feb 2019) Sr. Clinical Research Consultant- Scientific Management and Technology (SMT) Department

Indication: Infection Disease (HIV & Hepatitis-B, C} Responsibilities/Tasks:

• Facilitated the set-up of the Clinical Research Department

• Selected Vendors (Central Laboratories and Clinical Research Organizations)

• Negotiated contracts and budgets for research studies, with vendors.

• Performed GCP/GLP audits during selection of Central Laboratories

• Created Infrastructure and implement procedures within the Clinical Research Department

• Implemented procedures and structures during the set-up of the Department.

• Conducted Quality Assurance and GCP audits and created and provided training plans.

• Initiated and managed all clinical trials within the research department.

• Maintained all Institutional Review Board submissions and maintenance. Paion, Inc. (July 2016-Feb 2017)

Oversight Monitor (Part-Time)

Indication: Lung disease diagnoses by through Bronchoscopy 3

Responsibilities/Tasks:

• Assessed performance of site monitors

• Conducted GCP audits for all thirty-five selected sites.

• Functioned as liaison between CRO and Paion

• Ensured safety and site management issues were resolved adequately.

• Ensured study conduct was following study protocol, GCP and FDA guidelines. INC, LLC. (July 2016-December 2017)

Sr. Clinical Research Associate Consultant (Part-Time) Responsibilities/Tasks:

• Performed and coordinated all aspects of the clinical monitoring process in accordance with GCPs and FDA-guidelines to assess the safety and efficacy of investigational products and/or medical devices.

• Conducted site visits to determine protocol and regulatory compliance, and prepared required documentation.

• Reviewed essential documents for compliance with ICH-GCP

• Performed the function of primary liaison between site and in house teams.

• Prepared study monitoring tools, Case Report Form completion guidelines and source documents

• Phase I, study in healthy volunteers with low Testosterone levels.

• A Phase 3 Multicenter Study of the Long-term Safety and Tolerability of ALKS5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults who have and Inadequate Response to Antidepressant Therapy (The FORWARD-2 Study)

• A Phase 3 Efficacy and safety Study of Alk5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-3 Study)

PPD, (Jan 2016 – Jul 2016)

SWAT Team – Sr. Clinical Research Associate Consultant Indication: Oncology (Leukemia and Lymphoma)

Responsibilities/Tasks

• Conducted site rescue activities for problematic clinical research sites. Protocol:

• A Phase 1/2A Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCR epsilon and 4-1BB Signaling Domain in Patients with Chemotherapy Resistant or Refractory CD19 + Leukemia and Lymphoma Quintiles-Amgen, (Oct 2014 – Dec 2016)

SWAT Team - Sr. Clinical Research Associate Consultant Indications: Oncology, Hyper Lipidemia

4

Responsibilities/Tasks:

• Conducted site rescue activities for problematic clinical research sites. Protocols monitored:

• A Phase 1, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in subjects with Advanced or Metastatic Solid tumors.

• A Phase 1b, Multi-center, Open-Label Trial to Evaluate the Safety and Efficacy of Talimogen Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects with previously Untreated, Unresected, Stage 3b-4 Melanoma.

• A Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 mcg Once-Every-3-Weeks in Anemic Subjects with Advanced Stage Non-Small Cell Lung Cancer Receiving Multi-Cycle Chemotherapy

• A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG145) is Used in Combination with Statin Therapy in Patients with Clinically Evident Cardiovascular Disease

• An Open-Label, Randomized, Phase 3 Trial of Nivolumab versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-Small Lung Cancer

(NSCLC)

• An Open-Label, Randomized, Phase 3 Trial of Nivolumab versus Investigator’s choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+Non-Small Lung Cancer

• Oncology: Thromboembolism prevention in Children with newly diagnosed Acute Lymphoblastic Leukemia

• A Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at five hundred ug Once-Every- 3-Weeks in Anemic Subjects with Advanced Stage Non-Small Cell Lung Cancer Receiving Multi-Cycle Chemotherapy

Takeda Pharmaceuticals U.S.A., Inc., (Jul 2013-Oct 2014) Regional Clinical Research Consultant

Responsibilities/Tasks:

• Conducted all site management activities (selection, continue project training, start-up, Initiation, Monitoring, and Close-Out activities for problematic clinical research sites. Protocols Monitored:

• Depression (MDD), 1-year multi-center trial, with combination therapy (Double-Blind, Fixed-dose and Open-Label) trial including 370 subjects.

• Epilepsy; Phase 2, 2-years multi-center study in patients with Acute Repetitive Seizures

• ADHD; Early phase trial investigation of the Usability of d-Amphetamine Transdermal system in Children, Adolescents and Adults with ADHD 5

Keryx Bio-Pharmaceuticals, Inc., (Aug 2012–Jun 2013) SWAT Team - Regional Clinical Research Consultant

Indication: End-Stage Renal Disease

Responsibilities/Tasks:

• Conducted site rescue activities for problematic clinical research sites. Protocols Monitored

• End-Stage Renal Disease (ESRD); Long-Term Safety Extension Trial in Patients with ESRD on Dialysis

• End-Stage Renal Disease (ESRD); A Three-Period, 58-Week Safety and Efficacy Trial in Patients with ESRD on Dialysis

Sanofi-Aventis, (Sep 2010-Mar 2012)

Regional Clinical Research Consultant

Indications: Oncology

Responsibilities/Tasks:

• Conducted all site management activities (selection, continue project training, start-up, Initiation, Monitoring, and Close-Out activities for problematic clinical research sites. Protocols Monitored

• Oncology; Extension trial in patients with node positive and high-risk node negative breast cancer

• Oncology; 2-year multi-center trial including 105 patients with node positive and high- risk node negative breast cancer.

Amgen, (Jun 2008-Aug 2010)

Regional Clinical Research Consultant

Responsibilities/Tasks:

• Conducted all site management activities (selection, continue project training, start-up, Initiation, Monitoring, and Close-Out activities for problematic clinical research sites. Protocol Monitored:

• Oncology (multiple myeloma in plasma cells of bone marrow), multi-center trial with 105 patients

AtheroMed, Inc., (Apr 2006-Mar 2008)

Regional Clinical Research Consultant

Indications: Cardiovascular

6

Responsibilities/Tasks:

• Conducted all site management activities (selection, continue project training, start-up, Initiation, Monitoring, and Close-Out activities for problematic clinical research sites. Protocols Monitored:

• Endovascular Atherectomy safety and effectiveness study, in patients undergoing Surgery.

• Device/EDC trial including 105 subjects.

Cardiva Medical, Inc., (Apr 2006-Mar 2008)

Regional Clinical Research Consultant

Indications: Cardiovascular

Responsibilities/Tasks:

• Conducted all site management activities (selection, continue project training, start-up, Initiation, Monitoring, and Close-Out activities for problematic clinical research sites. Protocols Monitored:

• Cardiovascular; Phase 1 (Pharmacokinetics & Pharmacodynamics) trial including 105 subjects.

• Cardiovascular: Rapid Extra vascular sealing via percutaneous collagen implant in patients undergoing Catheterization. Multicenter Device/EDC trial including ninety-six subjects.

Inset/Flowonix-Medical, Inc., (Nov 2007-Jun 2012)

Regional Clinical Site Manager

Indication: Pain Management

Responsibilities/Tasks:

• Conducted all site management activities (selection, continue project training, start-up, Initiation, Monitoring, and Close-Out activities for problematic clinical research sites. Protocols Monitored:

• PUMP (Prometra’s Utilization in Mitigating Pain), 2-years Multicenter device study including two hundred subjects.

Taisho Pharmaceuticals, Inc., (2005)

Regional Clinical Research Consultant

Indication: Dermatology

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Responsibilities/Tasks:

• Conducted all site management activities (selection, continue project training, start-up, Initiation, Monitoring, and Close-Out activities for problematic clinical research sites. Protocol Monitored:

• Phase 1, 6 months’ multi-center trial in patients with A-Topic Dermatitis (Feb 2005-Aug 2005)

• Phase 2, 24-months multi-center trial in patients with A-Topic Dermatitis (Oct 2005- Aug 2006)

AAI-Development, Inc., (2002)

Regional Lead Clinical Research Consultant

Indications: Psychosis/Schizophrenia & Oncology

Responsibilities/Tasks:

• Conducted all site management activities (selection, continue project training, start-up, Initiation, Monitoring, and Close-Out activities for problematic clinical research sites. Protocols Monitored:

• Schizophrenia Study: 1-year Multi-center EDC trial in patients with mental illness

(symptoms include delusions, hallucinations, disorganized speech)

• Oncology Study (multiple myeloma); 1-year multi-center trial with 105 patients

(Amgen)

Scirex, Inc., (2000-2002)

Senior Lead Clinical Research Associate/Core Team Member Responsibilities/Tasks:

• Designed Clinical Trial Protocols, Informed Consent documents and Case Report Forms. Performed clinical research site qualification visits.

• Performed qualifying site visits, interim monitoring visits, and site close out visits.

• Represented the company during sponsor meetings.

• Managed a group of six field monitors.

• Function as facilitator for field monitors

• Conducted training on study protocols for study coordinators and investigators.

• Created CRF completion guidelines and provided monitoring training.

• Assigned field monitors to Clinical Research Sites

• Organized and participated in clinical investigator meetings.

• Schizophrenia Study: 18 months’ trial, with 150 patients diagnosed with Schizophrenia

(symptoms include lack of expressed emotion, lack of speech etc.)

• Epilepsy/Seizure Study, Phase II/III, 12 months’ trial, with one hundred patients

• Oncology Study (multiple myeloma) 1-year trial with 150 patients

• Depression Study with psychotic features, 18 months’ trial with one hundred patients 8

Suriname Government, (1997-2000)

Director Drug Regulatory Affairs for the Ministry of Health

• Responsibilities included day to day management of the department, review Investigational New Drug Applications and New Drug Applications, submitted by pharmaceutical companies to receive marketing approval. Solvay Pharmaceuticals, Inc., Netherlands, (1988-1990) Senior Clinical Research Associate

• Phase 1-4 studies

• Studies performed in several therapeutical areas such as: Dermatology, CNS, Vaccines, Cardiovascular, Oncology, OB-GYN, Infectious disease. Solvay Pharmaceuticals, Inc., Netherlands, (1988-1990) Clinical Research Associate

• Phase 1-4 studies

• Studies performed, Dermatology, CNS, Vaccines, Cardiovascular, Oncology, OB-GYN, Infectious disease, Medical Devices

EDUCATION, CERTIFICATIONS, TRAINING

• Master of Business Administration (MBA), Strategic Management, Florida Metropolitan University, Tampa, FL, 2002

• BSc in Biochemistry, December 1987

• PMP-Certificate

OTHER PROFESSIONAL ACTIVITIES

• GCP training completed Sept 2013

• Society of Clinical Research Associates (SoCRA)

• MAGI member since 2009

• CITI GCP ongoing training

• CCRA through ACRP 2000-present

SOFTWARE PROFICIENCY

• Microsoft Office applications: Word, Excel, and PowerPoint

• IMednet, InForm, Medidata Rave, Octagon FUSE, Medrio

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