Miranda Haith has over 14 years of experience as a clinical research project manager, primarily in oncology trials. She has a proven track record of leading clinical research teams, developing study plans and protocols, managing study timelines and budgets, and ensuring regulatory compliance. Her expertise includes all phases of oncology clinical trials using RECIST v1.1 for tumor response and electronic data capture systems. She is proficient in Microsoft Office, clinical trial management systems, and has worked with pharmaceutical companies and contract research organizations.

1. M IRANDA HAITH, B S , C C R A
336-383-7694
mirandahaith@gmail.com
CLINIC AL RE S E ARC H PROJE C T MANAG E R
Detailed, organized clinical research professional for 14 years with seven years of experience leading clinical
research field teams, primarily in oncology, and a Master of Public Health degree. Strong expertise in phase I-III
oncology trials (using RECIST v. 1.1) and electronic data capture (EDC) trials. Proven ability in site selection, study
plan and protocol development, and diverse team member training. Highly accomplished project management,
including study timelines, patient recruitment and retention, and data cleaning and reporting. Successful
independent supervision/monitoring of clinical research associates and overseeing study documentation
according to standard operating procedures (SOPs), ICH/GCP guidelines, and regulatory requirements. Excellent
written and verbal communication skills. Strong computer skills. Experience with pharmaceutical companies and
contract research organizations (CROs). Proficiency in Microsoft Office, RAVE, InForm 4.6, Microsoft Project,
Oracle, and CTMS.
THERAPEUTIC AREAS OF EXPERTISE
 Endocrine/Metabolic: Diabetic Macular Edema, Diabetic Retinopathy
 Gastrointestinal: Erosive Esophagitis, Irritable Bowel Syndrome
 Infectious Disease: HIV
 Neurology: Epilepsy, Parkinson’s disease (early-stage)
 Oncology: Acute Myeloid Leukemia, Breast Cancer, HIV Related Lymphoma, Non-Small Cell Lung Cancer,
Oncology Related Pain, Ovarian Cancer
 Respiratory/Pulmonary: Asthma, Idiopathic Pulmonary Fibrosis
 Urology: Chronic Renal Insufficiency, Stress Urinary Incontinence
PLANNING & IMPLEMENTATION
 Develops study plan and protocol through review of marketing strategy, regulatory submissions, and
participation at meetings with FDA.
 Contribute to site selection and monitoring plans.
 Manages study start-up activities.
 Develops study plan and study specific tools.
 Participates in proposal development and bid defenses.
 Provides leadership and conducts training of team members and site staff on SOPs, study protocol, and
form completion. Serves as primary contact on questions.
 Tracks patient recruitment and correspondence.
 Manages vendors and orders clinical trial supplies and equipment. Resolves drug supply issues at sites.
 Monitors initiation process by tracking schedules, conducting site visits, and reviewing status reports.
CONDUCT & QUALITY CONTROL
 Implements study plans according to timelines and specific guidelines.
 Controls the study financials by reviewing invoices prior to approval and monitoring budgets.
 Follows up with site in regards to data cleaning and ensures updates are completed for eTMF and CTMS
data systems. Strong knowledge of medical terminology.
 Conducts monitoring visits to ensure compliance with ICH/GCP guidelines, site, and sponsor SOPs.
Supports site staff, mentors less experienced personnel, and facilitates teamwork.
 Reviews site visitreports and follows up on items needing clarification.
 Prepares and presents study progress and recommended improvements at team and review meetings.
 Maintains timely and effective communication among team members and site staff.

2. CLOSEOUT & REPORTING
 Contributes to writing the final clinical study report.
 Performs data analysis and interpretation of the clinical study report.
MIRANDA HAITH, page 2
WORK HISTORY
Clinical Team Leader, INC Research, Jul. 2015 – Present
 Therapeutic Areas: Oncology
o Site management and site staff performance including monitoring all types of clinical trials
ensuring adherence to Good Clinical Practices, investigator integrity and compliance with all
study procedures. Data Handling, Reporting and Tracking & Administrative tasks. Performing
management of study site activities to ensure the integrity of clinical data, in adherence to all
applicable regulatory guidelines. Communication - Keeps project leadership apprised of team
issues, seeking guidance as needed. Maintains timely and effective communication among team
members and site staff. Attends Kick-Off, Quick Start, and Investigator meetings. Regulatory
Documentation - Independently resolves protocol questions with the Project Manager (PM) and
patient related issues with the Medical Monitor (MM). Maintains a record of all contacts with the
PM or MM concerning protocol deviations and clarifications. Monitoring - Develops clinical plans
and guidelines, including clinical monitoring plans. Assures compliance with monitoring
intervals according to the project requirements. Typically acts as LCRA on studies. Reviews the
study scope of work, budget, and protocol content. Provides training to project teams on
protocol, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs),
clinical plans and guidelines, and timelines for the study. Leads weekly project calls with
CRAs. Responsible for site assignments for CRAs. Ensures study specific training requirements
are completed and documented. Provides assistance and/or co-monitoring with regional team
for high enrolling or problematic sites. Collaborates with internal project team members to
assure timely site initiation process. Facilitates the site selection process utilizing Quick Start
methods and appropriate feasibility assessments, if applicable. Assists the PM with tracking site
initiation status, including Institutional Review Board (IRB) approvals and scheduling of site
initiation visits to coincide with shipment of clinical supplies. Reviews site visitreports
according to Company or Sponsor requirements. Line Manager –Responsible for the supervision
and administrative oversight of direct reports, which are most commonly CRAs. Develops
training plan and assures training compliance for all direct reports. Evaluates
strengths/developmental opportunities of staff members. Sets clear goals and objectives for all
direct reports. Completes performance reviews and implements performance plans. Ensures
CRA metrics are met. Meets regularly with direct reports to mentor them and to evaluate
workload and metric compliance. Provides data for the maintenance of resourcing tools.
Clinical Project Manager, Quintiles Transnational, Sep. 2014 – Jul. 2015
 Therapeutic Areas: Internal Medicine
o Contribute to the development of the project delivery strategy for RFPs. Participate in bid
defense preparations. Participates in bid defense presentations in partnership with Business
Development and may lead the presentation for smaller, less complex, local studies. Understand
project strategy and translate the agreed upon approach. Develops integrated study
management plans with the core project team and/or sub-team. Accountable for the execution
of clinical studies, or assigned portion of clinical studies, per Contract while optimizing speed,
quality and cost of delivery and ensuring consistent use of study tools and training materials and
compliance with standard processes, policies and procedures. Set objectives of the core project
team and/or sub-team(s) according to agreed upon contract, strategy and approach effectively
communicate and assess performance. Collaborate with other functional groups within the
company where necessary to support milestone achievement and to manage study issues and
obstacles. Monitor progress against Contract and prepare/present project and/or sub-team
information proactively to stakeholders internally and externally. Manage risk (positive and
negative) and contingencies proactively and lead problem solving and resolution efforts.
Achieve project quality by identifying quality risks and issues, responding to issues raised by
project team and/or sub-team members and planning/implementing appropriate corrective and
preventative action plans. Serve as primary project contact with Customer. Build the cross-
functional project team and/or sub-team(s) and lead their efforts; responsible for managing
cross-collaboration of the core team and for overall project delivery to support milestone

3. achievement and to manage study issues and obstacles. Responsible for ensuring the financial
success of the overall project and/or project sub-team. Forecast and identify opportunities to
accelerate activities to bring revenue forward. Identify changes in scope and manage change
control process as necessary. Identify lessons learned and implement best practices. Adopt
corporate initiatives and changes and serve as a change advocate when necessary. Provide input
to line managers of their project team members’ performance relative to project tasks.
Regional Study Lead/Sr. Project Manager, inVentiv Health (for AbbVie Pharma), Feb. 2014 – Jun. 2014
 Therapeutic Areas: Oncology
o Responsibilities: manage project study teams under various complexity to meet study timelines
with minimal oversight; primary interface for management of CRAs monitors and investigative
site personnel for study related communications; ensure alignment with program/study strategy
within a region of countries; provide regional feedback on vendor performance to the study
manager and work to resolve issues; provide study status updates/progress reports reflect
regional status and ensure key elements are clearly communicated as appropriate; Ensure all
systems reflect current study status for assigned regions; in collaboration with the study
manager, contribute to the content development and delivery of internal and external study-
related training; supported studies of more than one therapeutic area; responsible for problem
solving, risk mitigation, and contingency plans; ensure the country and ethics submissions are
completed in assigned region(s) within plan timelines; contribute to the development of protocol
and study related documents with input from other key stakeholders; identify quality
investigative sites and contribute to site selection at the study level; work to resolve issues
requiring follow-up; provide regional input to the study budget to define negotiation parameters;
liaise with affiliate office to obtain status and drive execution of contracts and site budgets;
contribute to the development of and testing of the specifications of various systems such as EDC,
IRT, ePRO, etc.; contribute to the planning and coordination of internal and external meetings
both investigator and monitor meetings; actively identify an address quality and compliance
concerns within assigned region(s); ensure audit/inspection readiness at site level within
assigned region(s), as well as assisting in the preparation of audit/inspection responses; mentor
less experienced Regional Managers; oversee both local and international study teams.
Contract Associate Project Manager/CMLa, Boehringer-Ingelheim Pharmaceuticals (for Premier Research),
Feb. 2012 – Feb. 2014
 Therapeutic Areas: Oncology, Endocrinology, Respiratory
o Responsibilities: manage project teams to meet study timelines; develop study tools and training
materials for both site personnel as well as project team; completion of study management plans
for the study team; primary contact for CRO/Vendors ensuring communication is upheld; review
and manage project budgets with primary CML; prepare and present during internal and external
meeting when needed; oversee CRA team to ensure team performance and efficiency; track site,
IRB and regulatory documentation as well as ensure adequate investigational product,
equipment and trial supplies are available; follow-up of site recruitment, correspondence, EDC
entry and data cleaning; ensure and review site documentation and training remain up-to-date;
SAE reconciliation and adjudication of serious adverse events.
Contract Clinical Study Manager, Merz Pharmaceuticals, Nov. 2011 – Apr. 2012
 Therapeutic Areas: Dermatology, Neurology
o Responsibilities: executed trials in accordance with applicable regulations and ensure quality of
clinical data generated met the clinical trial FDA requirements; initiated and managed clinical
business development needs as well as product and marketing; develop clinical aspect of
regulatory strategy as part of a multidisciplinary team; participate in FDA meetings and
submissions; contribute to site selection through site identification and review; manage product
safety; maintain and update both internal and external budgets; participate in annual budget
reviews; manage and provide ongoing project status to international and local teams; oversight
of CRO and CRO CRA/Monitors to ensure timelines are met.
Contract Lead Regional CRA-Oncology, Clinipace Worldwide, Sept. 2011 – Nov. 2011
 Therapeutic Areas: Oncology (AML Apheresis Transfer)

4. o Responsibilities: accountable for the quality of site performance for assigned sites; assist site,
internal staff and CRAs with preparation for GCP audits and FDA audits; developed essential
documents and tracking of site performance metrics; development of study tools for sites and
CRA use; finalization of the country recruitment and retention in collaboration with the Study
Project Manager; act as the primary liaison between the project team and the sponsor/customers
and service providers; train and maintain project team knowledge of project processes; provide
performance evaluation input for project team members and service providers.
Lead Regional CRA-Oncology, ICON Clinical Research, Sept. 2010 – Aug. 2011
 Therapeutic Areas: Oncology (MDS [RA with RARS, RA with RAEB, RAEB-T, CMML], AML, MM, NHL, HD,
Advanced Non-Hematologic Malignancies, Non-Small Cell Lung Cancer)
o Review of trip reports for CRAs; ensuring the escalation pathway is fully enforced prior to Project
Management involvement; development of Informed Consent Forms in accordance with
ICH/GCP guidelines; development of project training tools and materials for assigned CRAs and
sites; responsible for risk mitigation strategies, associated action plans and issue resolution;
provide direction and support to the clinical operations study team.
Lead Regional CRA-Oncology, INC Research, Inc., June 2008 – Sept. 2010
 Therapeutic Areas: Oncology (sAML, Non-Small Cell Lung Cancer, Ovarian Cancer)
o Ensure monitoring visits are performed in accordance with protocol requirements as well as
institutional and company SOPs; tracking of study reports; providing report status and updates
as well as study report sign-off; make certain all databases are updated with appropriate data in
regards to monitoring visit reports; ensuring the trip report content is complete and appropriate;
accountable for all monitoring visit report sign off timelines are met in accordance with the study
monitoring plan; keep project leadership apprised of team issues, seeking guidance as needed;
attend kick-off meetings, quick start, and investigatior meetings, independently resolves protocol
questions with the PM and patient related issues with the Medical Monitor; review of the study
scope of work, budget, and protocol content; prepare and present materials for bid defense
meetings; act as line manager for supervision and administrative oversight of direct reports for
CRAs/Monitors.
Lead Regional CRA-Oncology, PPD, Inc., July 2006 – May 2008
 Therapeutic Areas: Oncology (Non-Small Cell Lung Cancer, Ovarian)
o Facilitate cross-functional team meetings to ensure site readiness; responsible for development
and ensuring the distribution of mass site communication as needed; review of protocols and
protocol amendments; perform and coordinated all aspects of the clinical monitoring and site
management process in accordance with ICH/GCP, FDA guidelines, local regulations and PPD
SOPs; conducted site visits to assess protocol and regulatory compliance; assist project manager
on assigned projects where required; supported line manager to mentor, train and contribute to
the development of junior clinical team members
Contract In-House CRA-Oncology, PRA International, Jan. 2006 – July 2006
 Therapeutic Areas: Oncology (Non-Small Cell Lung Cancer)
o Assist in study site start-up activities; ensure IRB approvals are conducted within in a timely
basis; assist with contractual agreements amongst; liaise amongst CRAs and management to
ensure cohesiveness among the study team; reports to Associate Director of Site Management
with the CTM; site selection after review of the PSSV reports for site participation.
Contract Clinical Research Coordinator-Oncology, GlaxoSmithKline, July 2005 – Jan. 2006
 Therapeutic Areas: Oncology (Breast Cancer, Non-Small Cell Lung Cancer, Ovarian Cancer)
o Revitalization of study awareness to promote site enrollment; implemented site advertisements
to include radio ads, poster ads, etc. for increased study site enrollment; conducted site visits to
review site database thus increase potential study candidates.
Associate Project Manager, Quintiles, Sept. 2000 – Mar. 2005
 Therapeutic Areas: Oncology (Endocrine/Metabolic (Diabetic Macular Edema, Diabetic Retinopathy);
Gastrointestinal (Erosive Esophagitis, IBS); Infectious Disease (HIV); Neurology (Epilepsy, Parkinson’s

5. Disease-early stage); Respiratory/Pulmonary (Asthma); Urology (Chronic Renal Insufficiency, Stress
Urinary Incontinence)
o Assist project manager in the implementation of study trial enrollment; supervise 20-75
employees providing site enrollment qualification; provide study reports, tracking enrollment
and site referrals; oversee study start-up activities to include CDAs, IRB submission, contractual
negotiations, etc.
EDUCATION & TRAINING
Master of Public Health Degree
Walden University, Baltimore, MD
Bachelor of Science Degree - Human Development and Environmental Sciences
University of North Carolina, Greensboro, NC
Certified Clinical Research Associate (CCRA)
AFFILIATIONS
American Association for Cancer Research (AACR)
AmeriCare Family Practice Advisory Group
Association of Clinical Research Professionals (ACRP)