Project Clinical Research

Angela Iheanacho

**** ****** **** ******, ** ****6

240-***-**** ******.**@*****.***

Experience Summary

Clinical Research Manager with 7 years of experience managing dynamic clinical research projects, with extensive focus on clinical trial establishment and management. Adept at procuring and allocating necessary resources for each clinical project. Focused on tracking project results, implementing data collection procedures, and verifying project data to ensure timely delivery of accurate results.

Core Competencies

Clinical Trial Management

SOP Implementation

ICH guidelines/ GCP Expertise

Phase I-IV Clinical Studies

Study Design/ Literature Review

Protocol/ Study Procedures Manuals

DIA TMF Reference Model

CDISC/ CDASH/ SDTM Standards

Title 21 Code of Federal Regulations

Regulatory Documentation Management

TMF Auditing/ Management

Monitoring Reports/ Clinical Study Forms

Quality Assurance Audits

FDA Audit Issues/ Guidelines

CTCAE/ RECIST Criteria

Technical Competencies

Operating Systems: Mac OXX, Windows 9x/NT/200/XP/Vista

Applications: Adobe Acrobat, AtTask, Cerner, CTMS Systems, EDC Systems (Inform, Oracle, Rave Medidata), GE Centricity Business IDX, Lotus Notes, Microsoft Office Suite (Access, Excel, Outlook, PowerPoint, Project, SharePoint, Visio and Word), SAS, Tableau, WebEx, SQLs

Therapeutic Experience

Oncology/Hematology, Respiratory, Autoimmune, Inflammatory, Cardiology, and General Medicine

Professional Experience

MedImmune Gaithersburg, MD

Clinical Trial Feasibility Manager May 2017- Present

Essential document collection and management through eTMF/ TMF systems

Work with clinical development, clinical operations and external CRO teams to perform advanced trial and site feasibility assessment according to study protocol and pipeline development requirements

Assess, incorporate, and curate data and information from available internal and external trial data resources, including Ta-scan, Citeline, KMR, IMPACT and other trial sources

Assess and review other products and data sources as appropriate

Assess historical recruitment rates, forecast future rates

Perform analyses to understand competitive landscape of product at global, country/region and site levels internally and externally

Build and maintain key site profile information, model site performance, and identify overused or underused sites

Keep up-to-date with literature regarding current and emerging therapeutic drug approaches and trial feasibility research

Inform/advise clinical project teams of new findings in supporting trial feasibility analysis

Contribute to clinical data review excellence practices among clinical teams

Assess various analytics and reporting tools and methods for analysis and visualization to address clinical data management and excellence business needs

Contribute to informatics initiatives with IS professional in trial feasibility and clinical data review excellence capability building

Leidos Health- CDMRP Frederick, MD

Clinical Trial Project Manager (1 Year Contract) May 2016- May 2017

Responsible for overall execution of clinical trials within designated study budgets, timelines and quality standards

Oversees set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance

Assists with implementation and supporting of eTMF/ TMF

Provides overall operational and strategic input prior to commencement of clinical trials that include, but are not limited to: clinical planning tools, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, Investigator selection, systems (e.g., CTMS, IXRS etc.), clinical trial related operational manuals, training materials, and various clinical trial plans (e.g., monitoring, risk mitigation, communication etc. plans) site selection and budget planning

Directs Clinical Operations team members on daily tasks and activities

Oversee and directs other team members on clinical monitoring and site activities to ensure compliance with Good Clinical Practices (GCP) and applicable regulations

Oversee clinical monitoring (site qualification, site initiation, interim monitoring, clinical trial closeout visits) to ensure integrity, accuracy and accountability of clinical data

Informs Clinical Operations Director and other leadership (as appropriate) on overall clinical trial status and of potential issues/mitigation

Participate on site visits as needed or accompany junior team members for training purposes.

Develops communication pathways and study specific processes to allow team members to communicate with clinical trial sites regarding all logistics including contract agreements, support materials and training and IRB/EC application process, including review of informed consent / HIPAA forms for conformance to pertinent government regulations

Develops study training for study team, investigational sites, and vendors

Develops and oversees clinical site budgets, investigator payment processes and invoices related to projects assigned

Key decision maker in the selection of clinical service provider personnel including contractors, and clinical research organizations, and with specification development, and management/oversight of third party personnel

Serves as the primary project contact for communication and coordination for the third-party vendors

Oversees the monitoring trip reports process and ensures resolution of all action items related to CROs

Ensures that vendors comply with all required standards and raises any issues and/or concerns

Oversee contract and budget preparation, negotiations and management throughout the trial life cycle

Facilitates Clinical Study Team meetings that comprise of cross functional representation and ensures that study information is disseminated to the appropriate parties

Oversees and manages other meetings to include: internal team meetings, investigator meetings, and other trial- specific meetings as required

Oversees in-house review of clinical data listings (protocol deviations, focused study data review, etc.) for completeness and accuracy and escalate issues as needed.

Implements corrective actions to avoid or mitigate problems while considering the appropriate trade-offs of balancing risks with study deliverables and costs

Ensures that the study regulatory files are collected and inventoried and filed as per regulatory guidelines and SOPs

Ensures study materials and supplies are appropriately managed in regards to ordering, tracking and within budgetary considerations

Ensures that study teams and clinical sites have the appropriate study management tools to execute the study

Act as a key contributor to the Clinical Operations department to include: clinical operations initiatives to streamline and improve processes, SOP development, Clinical Project Managers Forum, mentoring and developing Clinical Research Associates

AstraZeneca Pharmaceuticals Gaithersburg, MD

Clinical Project Manager (1 Year Contract) May 2015-May 2016

Develops clear and measurable project management plan in conjunction with Clinical Operations, Project Management, and Sponsor representative(s)

Management (within the country or regional geography) of clinical projects including deliverables from all functional areas and vendors in accordance with contractual timelines, sponsor specifications, quality and GCP

Defines timelines, milestones and scope of work limitations to project staff

Establishes project metrics and project report schedules with client representatives

Act as the primary liaison between the project team and the sponsor/customers and service providers

Identifies critical project success factors for tracking, analysis and reporting including probability and impact of potential project risks

Maintain eTMF/TMF, study site records and files, and ensure compliance with applicable regulatory guidelines and SOPs

Manages adherence to project budget and contracts and assists in the identification and development of scope change documents

Monitors project status, budget expenditures, and identifies problems and recommends solutions

Coordinates assignment of needed resources for project conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget

Develops budget and expense review strategy; creates scope definition documents and creates proactive cost containment strategies and communicates with project team; regularly reviews budget/expenses with project team

Identifies out of scope work and initiates the scope change process with sponsor representatives

Ensures the site contract and budget negotiation process is completed in accordance with project timelines and coast parameters

Responsible for review and approval of project grants, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members

Responsible for reviewing contracts/budgets with sites, providing support to legal department according to local/institutional requirements; negotiation of contracts and budgets with sites

Management and follow up of payments to investigators/sites, local vendors (when applicable)

Coordinates and interacts with vendors providing logistic support (depots, couriers, brokers), to ensure all processes required for the import/export, storage, distribution and tracking for investigational drugs, kits and/or related goods, are properly accomplished

Accountable for development, oversight and delivery of project team training

Determines needed project processes, trains and maintains project team knowledge/application of project processes

Establishes and communicates team performance expectations and guidelines

Manages performance of all service providers, delegating appropriate and challenging assignments to encourage growth, development and responsibility

Provides performance evaluation input for company's project team members and service providers

Participates in development and review of departmental Standard Operating Procedures (SOPs), guidelines, and intradepartmental procedures and other continuous process improvements programs, as assigned

Collaborates with Director, Clinical Operations, Project Management and Directors, Business Development in the development/presentation of capabilities/proposal defenses

Supports the development of project proposals by participating as requested; represents company's Project Management at professional, marketing and new business meetings

MedStar Washington Cancer Institute Washington, DC

Clinical Data Manager (6 Month Contract) February 2015- June 2015

Monitored work productivity and quality to ensure compliance with SOPs

Performed quality control audits to ensure accuracy, completeness, and proper usage of clinical systems and data

Managed clinical trials through review, computerization, cleaning and auditing of clinical data and databases in compliance with SOPs, client guidelines, regulatory agency guidelines, ICH-GCP, and FDA guidelines

Validated clinical trial data to ensure consistency, integrity, and accuracy, based on project specific guidelines

Queried data, resolved inconsistencies, and revised case report forms in compliance with standard operating procedures

Participated in the review of Clinical Research Documents (eg. Protocols, CRFs, Reports and Statistical analysis)

Abstracted medical information from source documentation (EMR's and other patient charts) in order to perform data entry into case report forms and EDC’s

Used RECIST criteria to evaluate effectiveness of tumor studies

National Cancer Institute (NIH) Gaithersburg, MD

Clinical Research Protocol Specialist September 2013-February 2015

Abstracted protocols and/or contact information into the appropriate clinical databases for use by the client and their collaborators in support of clinical trials

Edited and submitted clinical trial protocols/ regulatory documents to the FDA

Assisted in the preparation of contract required reports

Participate in the revision of SOPs and work instructions

Handled special client requests as assigned

Scheduled and coordinated weekly protocol review meetings

PAREXEL International Baltimore, MD

Clinical Research Associate November 2010- September 2013

Assisted coordinators, project managers and nursing/medical staff with study-related tasks

Performed monitoring visits (site qualification, initiation, interim, and close-out)

Performed study-related tasks, as directed, in accordance with protocol (clinical and bioanalytical), and project requirements

Supported of research projects by following protocol specifications, ICH and GCP guidelines, SOPs, unit specific competency training, and all work processes, to ensure efficient and compliant clinical operation of the Early Phase Clinical Unit (Phases I & II)

Performed Quality Checks (QC) on all data sources,as well as queried and resolved clinical data

Completed Case Report Forms (CRFs) in addition to monitoring visit reports and other necessary study reports

Responsible for managing data with Electronic Database Captures (EDCs), Electronic Medical Records (EMRs) and Trial Master Files (TMF)

Professional Affiliations

The National Association of Professional Women (NAPW)

Education

University of Maryland

Masters in Biotechnology and Bioinformatics (Honors) May 2013

Pennsylvania State University

Bachelors in Biology (Honors) May 2010

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