Christine Oswald-Tigerman, M.A., CCRP

SENIOR CLINICAL TRIAL MANAGER

**** ******** ***. ********, ********** 94044

Email: adzz2z@r.postjobfree.com BC: 484-***-**** C: 415-***-****

I have 16 years of experience in Clinical Research, I have 4 years experience as a Clinical Trial Manager, 8 years of experience as a Regional Senior Clinical Research Associate, and Regional Clinical Research Associate. I have a thorough knowledge of Clinical Research methods. I am also a dedicated Clinical Trial Manager who possesses far-reaching knowledge spanning several therapeutic areas and indications due to experience as a Senior Regional Clinical Research Associate and Operational Knowledge of Skilled Nursing Homes. Therapeutic experience includes: Autoimmune, Pediatric, Central Nervous System, GI/GU, Immunology, Infectious Diseases, Endocrine/Metabolic, Cardiovascular, and Oncology. I want to find an opportunity in Clinical Research to apply my extensive medical background, including my time as an Executive Director of a Skilled Nursing Facility (NHA), to assist an organization to conduct efficient, safe and effective research.

EDUCATION

Professional Certificate in Clinical Trials Design and Management, University of Santa Cruz, Santa Cruz, CA, UC Extended Studies Program, Spring 2008

M.A., Special Major in Business, Psychology, and Gerontology with an emphasis in Long Term Care Administration, 2005

San Francisco State University, San Francisco, CA

B.A., Liberal Studies, 1999

San Francisco State University, San Francisco, CA

Medical Research Management, Inc. an accredited through ACPE February 2007

Clinical Research Associate Education and Training Program

“Fundamentals of Clinical Research” 140-hour Training Program Comprehensive training GCP (Good Clinical Practices) 21 CFR 312 IND, 21 CFR 50, 21 CFR 56 IRB, 45 CFR 46, 21 CFR 54, International Conference on Harmonization (E6) GCP Consolidated Guideline and (E2A) Clinical Safety Data Management, HIPAA Training Program: 20 Hours Complying with the Privacy Rule in Research

THERAPEUTIC EXPERIENCE

Endocrine/Metabolic: Diabetes Mellitus Type 1, Diabetes Mellitus Type 2, Disorders of Lipoid Metabolism, Diabetic Retinopathy, Dyslipidemia, Treatment of Type II Diabetic patients with Nephropathy, Metabolic Disorders

DAIT/ITN/NIAID: Division of Allergy, Immunology, and Transplantation (DAIT), Immune Tolerance Network (ITN), Division of Allergy, Immunology, and Transplantation (NIAID)

Nervous System/Sense Organs: Alzheimer's disease: Amyotrophic Lateral Sclerosis Multiple Sclerosis, Parkinson’s disease

NIH: National Institutes of Health (NIH)

Cardiovascular/Pulmonary/Respiratory: Hyperlipidemia, Hypertension, And Acute Pulmonary Heart Disease, PPHN (Neonates) (Unblinded Pharmacy)

Autoimmune/Inflammation: AIDS/Hepatitis C, Hepatitis C

Infectious Disease: AIDS/Hepatitis C, Hepatitis C

Immunology: Diabetes Mellitus Type 1, Liver Transplant, Kidney Transplant, and Rheumatoid Arthritis

Immunology Pediatrics: Pediatric Living-donor Liver Transplant,

Pediatric Autoimmune: Oral Immunotherapy, Peanut Allergy

Oncology: Breast, Gastric, NSCLS, Small Cell lung cancer (SCLC), and (Colon, Gastric, Thyroid Carcinoma, Glioblastoma, Gastroesophageal Junction, Gastroesophageal Cancer, Head, and Neck Cancers, Renal Cancer, Papillary Hereditary Renal Cell Carcinoma, Alveolar soft part sarcoma, Cholangealcarcinoma, hepatocellular cancer gastric and colorectal ((ALK Negative, ALK Positive, Met Exon 14 deletion, C-Met Amplified, ROS Positive, Enriched Other, Hypogonadism)), HER2 Breast Cancer (BC), cancer (UC), Urothelial Carcinoma, Breast Cancer, mCRPC, NSCLC, Ovarian Cancer, GC/GEJ Cancer, Gastric Cancer Primary Myelofibrosis (PMF), Post-Polycthemia vera MF (Post-PV-MF)

VA: Veteran’s Administration

PROFESSIONAL EXPERIENCE

Christine Oswald-Tigerman, LLC., (Pacifica, CA), (Contract)

Clinical Trial Manager July 2022- Current

Act as a direct contact with assigned clinical sites, use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites

Maintain a working knowledge of GCP/ICH Guidelines and ensures compliance with applicable ICH-GCP Guidelines, international and local regulations, SOPs, other training requirements and study specific procedures and training

Prepare and track of study participant enrollment projections vs. actuals and study budgets

Prepare for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites to determine protocol and regulatory compliance, and prepared required documentation

Provide recommendations regarding site-specific actions and use judgment and experience to assess ability of site staff

Ascertain and recommend appropriate follow-up response to issues at clinical sites including potential deficiencies in documentation, communication, and the need for additional training

Preform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and complete appropriate documentation (confirmation, follow-up letters, trip reports, and /or communication logs) as required

Act as Functional/Technical Subject Matter Expert (SME) as required

Manage all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity

Provide clinical trial support, mentoring, leadership, guidance, and direction to Clinical Research Associates (CRAs) assigned to clinical studies

Apply judgment and knowledge to independently resolve site issues

Manage the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial

Maintain a working knowledge of and Update all appropriate Clinical Trial Management systems (CTMS) as indicated per function on an ongoing basis

Monitor patient safety on-site and address protocol violations and immediately provide report and recommendations to the Functional Lead (FL)

Manage sites and protocols across multiple therapeutic areas independently

Kartos Therapeutics (Redwood City, CA), (Permanent)

Associate Clinical Trial Manager September 2021-July 2022

Manages vendors Independently running Phase 2 trial as a member of the study team

Manages components of Phase 2 as a member of the study team

Develops tools and processes that increase measured efficiencies of the Study Project

Manages the implementation, on-time execution and conduct of clinical studies, including the

development of study plans, key milestones, timelines, study costs, vendor selection as well as

ensuring quality and compliance

Provides effective study updates and tracking of progress to Senior Management

Ability to identify potential risks that may impact the studies, e.g., study data, ethical conduct and Adherence to ICH guidelines

Provides Risk Mitigation solutions for issues that impact the Study

Appropriately manages the various stages of study activities, e.g., start-up, treatment, Maintenance, and close-out

Ensures study is conducted on time and within budget

Understands the data requirements of clinical studies to ensure quality and integrity of data during collection, review, cleaning, and monitoring

Follows up on assigned team action items and identification, escalation, and resolution of issues as needed

Maintains a working knowledge of GCP/ICH Guidelines and ensures compliance with applicable ICH-GCP Guidelines, international and local regulations, SOPs, other training requirements and study specific procedures and training

Demonstrates expertise to support SOP development and implementation

Demonstrates through knowledge of FDA and EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies

Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports

Effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams

Anticipates obstacles and proactively develops solutions to achieve project goals

Demonstrates a general understanding of functional issues and routine project goals from an organizational perspective

Applies judgment and knowledge to independently resolve vendor issues, site issues and study issues

Manages the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial

Maintains a working knowledge of and update all appropriate Clinical Trial Management systems (CTMS) as indicated per function on an ongoing basis

Comprehends and Interprets Protocol knowledge and explains protocol requirements to others

Occasionally Trains CROs, vendors, investigators and study coordinators on study requirements

Serves as a resource for others within the company for clinical trials management expertise

Manages studies or programs of higher complexity from both a process and strategic perspective

Collaborates with vendors and in-house experts to review and negotiate site-specific study budgets

Demonstrates an ability to interact with contacts cross-functionally at senior levels within the Company

Manages Clinical Research Organizations (CRO’s), Sites and Protocols across multiple therapeutic areas independently

Works with Pharmaceutics and pharmaceuticals in a day-to-day compacity

Demonstrates the ability to Identify, engage, and manage the activitiesof clinical CROs and other clinical study providers

Demonstrates the ability to complete an overview of the El ectronic Data Capture (EDC)

Demonstrates the ability to complete an overview of the Data Management

Gilead Sciences (Foster City, CA), Sharp Decisions (New York, NY), (Contract)

Senior Clinical Trial Management Associate September 2020-September 2021

Manages Vendors Independently runs complex Phase 4 study

Manages components of Phase 4 trial as a member of the study team

Develops tools and processes that increase measured efficiencies of the project

Coordinates and Assists in the setting and updating of Study timelines

Coordinates and Assists with CROs or Vendors

Fully understands the science and processes behind Clinical Operations

Identifies solutions to study issues based on precedent

Leads a cross functional team to accomplish study objectives

Demonstrated ability to work independently and required less supervision

Demonstrated ability to lead a team on more complex studies

Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies

Assures site compliance with the protocol and regulatory requirements

Knowledge of FDA and or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies

Acts as a direct contact with assigned clinical sites, use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites

Assesses of adequacy/feasibility of potential clinical investigators and sites

Maintains a working knowledge of GCP/ICH Guidelines and ensures compliance with applicable ICH-GCP Guidelines, international and local regulations, SOPs, other training requirements and study specific procedures and training

Reviewing and contributing to the development of study-specific documentation including clinical trial protocols, case report forms, study guides/manuals, informed consent forms, and clinical databases

Demonstrates expertise to support SOP development and implementation

Demonstrates through knowledge of FDA and EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies

Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports

Assists with the preparation of safety, interim, and final clinical study reports, and resolution of data discrepancies

Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites to determine protocol and regulatory compliance, and prepared required documentation

Provides recommendations regarding site-specific actions and use judgment and experience to assess ability of site staff

Ascertains and recommends appropriate follow-up response to issues at clinical sites including potential deficiencies in documentation, communication, and the need for additional training

Coordinates review of data listings and preparation of interim/final clinical study reports

Preforms site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and complete appropriate documentation (confirmation, follow-up letters, trip reports, and /or communication logs) as required

Conducts site evaluation, initiation, co-monitoring, and closeout visits in addition to routine monitoring visits, as required

Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams

Acts as functional/technical Subject Matter Expert (SME) as required

Participates in abstract presentations, oral presentations, and manuscript development.

Interfaces with individuals in other functional areas to address routine study issues

Participates in departmental or interdepartmental strategic initiatives under general supervision

Assures site compliance with the protocol and regulatory requirements

Manages all aspects of a clinical trial at all assigned countries, and clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity

Applies judgment and knowledge to independently resolve site issues and study issues

Manages the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial

Maintains a working knowledge of and Update all appropriate Clinical Trial Management systems (CTMS) as indicated per function on an ongoing basis

Comprehends and Interprets Protocol knowledge and explains protocol requirements to others

Develops clinical study monitoring priorities and Monitoring Plan in conjunction with CRO

Trains CROs, vendors, investigators and study coordinators on study requirements

Serves as a resource for others within the company for clinical trials management expertise

Manages studies or programs of higher complexity from both a process and strategic perspective

Demonstrates an ability to interact with contacts cross-functionally at senior levels within the Company

Manage investigational product accountability and reconciliation process

Monitors patient safety on-site and address protocol violations and immediately provide report and recommendations to the Functional Lead (FL)

Manages CRO, Sites and Protocols across multiple therapeutic areas independently

Demonstrates an Ability to write study protocols, study reports, sections for investigator brochures and regulatory documents (e.g., IND, NDA, etc.)

Coaches and Assists in the training of CTMAs and CPAs

Coaches members of a work team and ensures adherence to established guidelines

Prioritizes multiple tasks, plan proactively, and accomplishes goals using well-defined instructions and procedures

Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams

Anticipates obstacles and proactively develops solutions to achieve project goals

Demonstrates a general understanding of functional issues and routine project goals from an organizational perspective

Christine Oswald-Tigerman, LLC., (Pacifica, CA), (Contract)

Clinical Trial Manager April 2020-September2020

Act as a direct contact with assigned clinical sites, use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites

Maintain a working knowledge of GCP/ICH Guidelines and ensures compliance with applicable ICH-GCP Guidelines, international and local regulations, SOPs, other training requirements and study specific procedures and training

Prepare and track of study participant enrollment projections vs. actuals and study budgets

Prepare for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites to determine protocol and regulatory compliance, and prepared required documentation

Provide recommendations regarding site-specific actions and use judgment and experience to assess ability of site staff

Ascertain and recommend appropriate follow-up response to issues at clinical sites including potential deficiencies in documentation, communication, and the need for additional training

Preform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and complete appropriate documentation (confirmation, follow-up letters, trip reports, and /or communication logs) as required

Act as Functional/Technical Subject Matter Expert (SME) as required

Manage all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity

Provide clinical trial support, mentoring, leadership, guidance, and direction to Clinical Research Associates (CRAs) assigned to clinical studies

Apply judgment and knowledge to independently resolve site issues

Manage the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial

Maintain a working knowledge of and Update all appropriate Clinical Trial Management systems (CTMS) as indicated per function on an ongoing basis

Monitor patient safety on-site and address protocol violations and immediately provide report and recommendations to the Functional Lead (FL)

Manage sites and protocols across multiple therapeutic areas independently

PAREXEL (Boston, MA), (Dedicated to PFIZER) Home Based in Pacifica, CA, (Permanent)

Clinical Site Manager II January 2018-April 2020

Regional Clinical Research Associate II August 2016-January 2018

Act as PAREXEL’s direct contact with assigned clinical sites, use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites

Manage sites and protocols across multiple therapeutic areas independently

Participate in Investigator and other external or internal meetings as required

Arrange on-site visits and logistics (e.g. travel arrangements)

Maintain a working knowledge of GCP/ICH Guidelines and ensures compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL training requirements and study specific procedures and training

Participate in the identification and selection of investigators and clinical sites

Prepare for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites to determine protocol and regulatory compliance, and prepared required documentation

Provide recommendations regarding site-specific actions and use judgment and experience to assess ability of site staff

Ascertain and recommend appropriate follow-up response to issues at clinical sites including potential deficiencies in documentation, communication, and the need for additional training

Preform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and complete appropriate documentation (confirmation, follow-up letters, trip reports, and /or communication logs) as required

Proactively keep manager informed about work progress and any issues (including conflicting priorities and free capacities)

Recognize out of scope activities and communicate to Functional Lead (FL)

Inform manager about work progress and any issues to avoid unforeseen situations and recommend solutions

Recognize impact of issues/delays/changes on study timelines and communicate to FL

Respond to company, client and federal regulatory requirements/audits

Act as functional/technical Subject Matter Expert (SME) as required

Manage all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity

Apply judgment and knowledge to independently resolve site issues.

Maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner

Interact with representatives of Client affiliates both within and outside clinical areas

Manage the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial

Maintain a working knowledge of and Update all appropriate Clinical Trial Management systems (CTMS) as indicated per function on an ongoing basis

Attend sponsor calls to stay informed of current study issues

Interpret data to identify protocol deviations or risk to date integrity

Monitor patient safety on-site and address protocol violations and immediately provide report and recommendations to the Functional Lead (FL)

Collaborate with and communicate with the CMA on-site issues/actions prior to planned visits and during the course of the trial

Delegate administrative and other tasks to ROAs as needed

Guide and mentor ROA, review work, and provide feedback to manager regarding performance

Manage sites and protocols across multiple therapeutic areas independently

AbbVie (North Chicago, IL), InVentiv (South San Francisco, CA) Home Based in Pacifica, CA, (Permanent)

Regional Clinical Research Associate II June 2015- August 2016

Perform site visits and monitor activities in accordance with the protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and complete appropriate documentation (confirmation, follow-up letters, trip reports, and /or communication logs) as required

Document observations in reports and letters in a timely manner using approved business-writing standards

Assess and ensures overall integrity of study and adherence to guidelines, protocols, and regulations and Conducts monitoring tasks in accordance with the approved monitoring plan

Apply judgment and knowledge to independently resolve site issues

Interpret data to identify protocol deviations or risk to date integrity

Provide recommendations regarding site-specific actions and use judgment and experience to assess the ability of site staff

Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites

Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines

Prepare for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites to determine the protocol and regulatory compliance, and prepare required documentation

Review and verifies case report forms and other clinical data for completeness and accuracy

Monitor patient safety, identify and address any protocol deviations

Manage all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity

Maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner

Evaluate overall performance of site and site staff

Ensure compliance and understanding of study requirements by site contacts

Generate queries and manage resolutions with site personnel

Participate in the identification and selection of investigators and clinical sites

Obtain, review and process regulatory and administrative documents from investigator sites

Work with junior staff on training, guidelines, and processes

Interact with representatives of client affiliates both within and outside clinical areas

Maintain a working knowledge of GCP/ICH Guidelines as well as all applicable regulations

Manage the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial

Respond to company, client and federal regulatory requirements/audits

Assess investigational product through physical inventory and records review

Participate in investigator meetings as necessary

Attend sponsor calls to stay informed of current study issues

Maintain & complete administrative tasks such as expense reports and timesheets in a timely manner

PRA, Health Sciences (Raleigh, NC) Home Based in Pacifica, CA, (Permanent)

Senior Regional Clinical Research Associate II June 2014- March 2015

Scientifically monitored clinical studies, which includes the review of case report forms (CRFs) and source documentation to ensure adherence to the protocol and consistency and scientific validity of the data

Identified potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites

Initiated clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted

Prepared for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites to determine the protocol and regulatory compliance, and prepared required documentation

Documented observations in reports and letters in a timely manner using approved business-writing standards

Escalated observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution

Assessed Investigational product through physical inventory and records review

Managed all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity

Conducted monitoring tasks in accordance with the approved monitoring plan

Provided full support including technical and scientific guidance to study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trials

Ensured adherence to study timeline and budget

Provided trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required

Ensured study systems are updated per agreed study conventions (e.g. Clinical Trial Management System)

Facilitated effective communication between investigative sites; the client company and the PRA project team through written, oral and/or electronic contacts

Assisted the project team in the tracking of enrollment rates and receipt and review of completed CRFs

Managed the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial

Responded to company, client and federal regulatory requirements/audits

Maintained regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner

Participated in investigator meetings as necessary

Attended sponsor calls to stay informed of current study issues

Served as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines

Maintained & completed administrative tasks such as expense reports and timesheets in a timely manner

Mentored junior level CRAs and serves as a resource for new employees

Performed assigned additional Clinical Operations tasks

Performed as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines

Performed assigned clinical tasks where advanced negotiating skills are required

Performed responsible for supervising other CRAs: Schedules and reviews trial tasks, provides leadership in the delivery of services to clients, ensures that staff fulfill their responsibilities in accordance with PRA’s policies, procedures, and SOPs, and ensures HR processes are properly implemented

Functioned independently with minimal oversight required

Served subject matter expert for CTM on monitoring related activities

Assigned to complex studies and/or sites

Provided leadership skills to assigned projects and within the Clinical Operations department

PPD, (San Diego, CA/Wilmington, NC) Home Based in Pacifica, CA, (Permanent)

Regional Clinical Research Associate Apr 2012- June 2014

Monitored investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification)

Assessed investigational product through physical inventory and records review

Documented observations in reports and letters in a timely manner using approved business-writing standards

Escalated observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution

Maintained regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner

Conducted monitoring tasks in accordance with the approved monitoring plan

Conducted site visits to determine the protocol and regulatory compliance and prepared required documentation

Managed Investigator payments

Participated in investigator meetings as necessary

Identified potential investigators in collaboration with the client company to ensure

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