Project Management Clinical Operations

Jacqueline Ongwenyi

**** ***** ********** *** **** 101

Los Angeles, CA 90049

Phone 424-***-****

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

SUMMARY OF QUALIFICATIONS:

Biopharmaceutical professional with significant drug development experience in project management, operations, and strategic planning for products and resourcing. Effective line manager adept at mobilizing resources, monitoring schedules and budgets, and producing project deliverables.

Track record of leading cross-functional teams smoothly from the planning stage through clinical trials and regulatory filings to US and international product approvals. Committed to excellence in the development and implementation of standardized processes.

Project Management: Develop successful execution of clinical program operational strategy with high quality, risk mitigation planning, and meeting timeline and budget targets.

Resourcing: Develop and implement a flexible resourcing model for Clinical Operations to ensure effective project support to meet the changing needs of programs across therapeutic areas.

Line Management: Global line management leadership experience, including coaching, mentoring, motivating, training and developing high performing clinical operations staff.

Process Improvement: Utilized operational expertise to address process gaps and collaborate with relevant functional areas to create and implement robust standard operating procedures for Clinical Operations, and ensure compliance with best practices.

THERAPEUTIC AREAS:

Immunology, Kidney Transplantation/Neurology, Oncology, Diabetes, Rheumatoid Arthritis, CNS, Hepatology/Gastroenterology, Infectious Diseases & Virology, Cardiovascular, Women’s Health

PROFESSIONAL EXPERIENCE

NantKwest

03/2017- Present

Clinical Study Manager

Strategic Planning

• Contribute to strategic planning to ensure optimized clinical development plans for assigned projects

• Analyze therapeutic program to construct appropriate resources and budgets

• Analyze therapeutic program to implement strategies and management tools

(e.g., clinical trial management systems, electronic data capture) to facilitate and improve operational and financial management of therapeutic program

• Analyze and develop action plans to address issues with investigational sites, CROs, etc

• Provide direction in CRO and vendor selection and management

• Provide feasibility assessment for new clinical protocols

• Assurance of regulatory compliance of investigational sites with company SOPs, regulatory and ICH guidelines

Project Management & Execution

• Manage clinical studies and the process to identify and solve operational issues and drive delivery to plan through internal and external partners (e.g., alliance partners, CROs and vendors)

• Responsible for project management and execution, including the development, initiation, conduct and maintenance of realistic, up to date and appropriate quality, project and study plans (including timelines and budgets) in agreed systems

• Oversee clinical trial conduct and monitor work performed internally and externally to ensure delivery against contract, according to budget and in accordance with corporate timelines

• Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory Affairs to ensure operational excellence

• Prepare, review and manage clinical research budgets, timelines and performance metrics

• Prepare the design, format and content and/or provide technical expertise for the development of essential clinical documents (e.g., protocols, CRFs, ICFs, SOPs, monitoring plans, clinical trials report, investigator brochures, study plans, study manuals, patient instructions)

• Act as operational interface with external partners (e.g., alliance partners, CRO and vendors) for externally managed/outsourced activities

• Review and provide technical expertise for vendor/partner contracts

• Track items related to CDAs, contracts, budgets and completion status

• Prepare study feasibility and study specifications

• Identify, recruit and approve clinical investigators.

• Maintain frequent contact and work effectively with site investigators and coordinators

• Prioritize study monitoring needs

• Review monitoring reports for accuracy, completeness and conformance with SOPs

• When necessary, monitor clinical sites for adherence to protocol and GCP, including: conducting site pre-qualification, initiation, monitoring visits, and close- out visits or co monitoring visits conducted by CRO personnel

• Review and resolve discrepancies in clinical data with clinical sites

• Resolve patient eligibility and protocol deviation issues

• Ensure appropriateness of investigational product forecast and manage the overall accountability and reconciliation process

• Manage Investigator, CRO and Vendor meetings

Therapeutic area of concentration: Oncology Phases I &II respectively Genentech, A Member of the Roche Group

10/2013- 11/2016

Consultant - Global Studies Manager

• Provide direction and leadership to one or more clinical operations teams

• Develop operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management

• Build effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables

• Create team culture and promote team spirit, Develop and maintain effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams. In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members

• Oversee the development and maintenance of study specific manuals created by the GSA

• Contribute to the development and management of the study timelines, resources, budget, risk and quality plans Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL

• Develop and manage clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans

• Communicate variances in the budget and action plan for resolution to the GSL

• Establish study milestones and ensure accurate tracking and reporting of study metrics

• Provide operational input into the development of protocol feasibility questionnaires

Therapeutic area of concentration: Immunology and Oncology Phases I II & IIIb respectively

Veloxis Pharmaceuticals, Inc.

12/2011- 08/2013

Consultant - Global Trial Manager

Manage and Lead the assigned studies on a day-to-day basis with regards to planning, organizing, communicating and implementing objectives to internal and vendor teams

• Lead the Company study team through close collaboration, team meetings and status updates. Ensure input and commitment from the various team members and stakeholders during the preparation, conduct, and in the reporting phase of the clinical study/studies

• Manage the Vendor teams participating in the assigned studies through day to day interaction and communication of study objectives, timelines and expectations. Work with Vendors to identify and solve study conduct and quality issues and sure that the study contract is complied with.

• Communicate timelines, identify milestones and report progress for the clinical studies

• Take lead/participate in vendor evaluation and selection and review of vendor cost proposals, budgets and contracts

• Participate and coordinate site and country selection through site feasibility surveys

• In collaboration with assigned Vendor, develop a subject recruitment strategy and monitor enrollment progress to assure that study milestones are met.

• In close collaboration with Company study team and Vendors, ensure development of a risk management plan for the conduct of the clinical study/studies

• Management of study budget in close collaboration with the Finance Department through careful forecasting and ongoing and consistent review of vendor invoices

• Responsible for preparing or delegating and supervising preparation of study protocol, amendments, CRFs, ICFs and various operational manuals for e.g. IVRS, EDC and other required documentation

• Participate in site visits i.e. pre-study visits, initiation visits, co-monitoring visits, and close-out visit as needed

• Review and approve reports from various study visits when submitted by the Vendor to ensure ongoing high quality of study conduct and generated data, proactively identify, analyze and report any serious compliance issues and develop an action plan for discussion and approval by Sr. Management if applicable.

• Assist with the preparation of required regulatory documents. Review and provide input to IBs, regulatory submissions/approvals, expedited/annual reports and Clinical Study Reports for given studies

• Training of monitors and Investigator/study personnel, in collaboration with other internal departments, if applicable

• Ensure appropriate compliance with GCP, SOPs, guidelines, and regulatory requirements

• Develop internal SOPs and processes for study management

• Therapeutic area of concentration: Kidney Transplantation and Neurology Phases II & IIIb respectively

Otsuka Pharmaceutical Commercial Inc,

5/2010 – 1/2011

Consultant - Associate Global Program Manager

• Responsible for project timelines and preparing routine monthly status reports

• Responsible for ensuring timely and accurate project information is available to the Project Manager

• Responsible for routine follow up of action items and team communications

• Supported quarterly forecasts, manages scope, timeline and financial changes through tracking variances at the project level

• Responsible for maintenance and follow-up of the project actions, decisions, issues (ADI) log for project team interactions

• Maintained and supported the development of mechanisms for monitoring project progress and for intervention and problem solving with team members and line managers

• Participated in CRO and ancillary service providers’ selection throughout the project

• Quantitatively assessed project issues and recommends resolutions to meet productivity, quality, and client-satisfaction goals and objectives supported in analysis of clinical development metrics

• Assisted with the Global Development Commercialization Plan (GDCP) preparations to the next action point, decision point development/analysis, and associated analytic

• Therapeutic area of concentration: CNS and Oncology Phases I, II & III respectively

Novartis Pharmaceuticals Corporation

1/2009 – 1/2010

Consultant - Global Program Data Manager

• Provide timely and professional ongoing management of project and clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines

• Serve as Project Data Manager for large projects or multiple smaller projects providing professional Data Management input on ICT(s)

• Responsible for ensuring consistency of protocols, Validation and Analysis Plans (VAPs) & Project eCRFs for all trials within assigned projects

• Business understanding of the compound profile (CDP/TPP) to identify and assist in successful application of data management processes and respond to Health Authority requests for data management issues

• Support and assist Assistant Data Managers and other Data Managers for allocated trials within assigned project(s)

• Contribute to the development of the Data Management organization through his/her leadership role within the DM Group

• Track and report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases

• Lead and support clinical & non clinical special projects

• Deputize for Data management Group Head and assist in coaching, training and mentoring of Data Management staff

• Therapeutic area of concentration: Oncology Translational Medicine Phase I & II respectively

Alpha Scientific

3/2007 – 1/2009

Consultant - Global Sr Clinical Research Associate Managing Simultaneous Contract assignments with Novo Nordisk, Hoffmann La-Roche, Eisai

• Participated in the development and presentation of training for Project Management department

• Provided mentorship to Junior and new employees at the Senior Project Associate, Project Associate and Administrative levels within CTO

• Provided oversight for Project Associate staff in the quality overview and consistency checks on informed consent forms (ICFs)Assist with the development and management of the detailed site feasibility process

• Coordinated the logistics of the study start-up processes Tracked all trial- related documents, including but not limited to Confidentiality Agreements (CDAs), contracts, regulatory documents

• Participated with the Project Manager in the design, ordering, shipping, tracking, and return of drug, ancillary, and other clinical supplies

• Coordinated internal receipt and routing of all Serious Adverse Event

(SAE) reports to the Project Manager, Clinicians, Clinical Research Associates (CRAs), and Product Safety & Surveillance Distribute Investigational New Drug (IND) safety letters to sites and ensure approval

• Liaised with Institute Review Boards and study site staff for submissions and approvals

• Participated with the Project Manager in budget preparation for trials, Process trial related invoices, Liaise with Clinical Business Management to ensure site payment reconciliation is based on performed work

• Therapeutic area of concentration: Diabetes Phase IV (Novo Nordisk)

• Therapeutic area of concentration: Oncology Phase I, II and III (Eisai)

• Therapeutic area of concentration: Rheumatoid Arthritis Phase III

(Hoffmann La-Roche)

Schering- Plough Research Institute

5/2006 – 3/2007

Consultant - Global Clinical Research Associate

• Primary point of contact for global field monitoring personnel concerning protocol explicit issues

• Afford accountability for the timely completion of site initiation start up activities by ensuring the proper implementation of pertinent documentation in support of the protocol and program

• Attend project meetings and effectively implement Site Management enrollment strategies and determine site feasibility

• Liaise with Clinical Finance on the development and implementation of a comprehensive Group strategy, including study timeline, budget negotiations, IRB approvals and ICF review within the portfolio allocated

• Assist in the planning of Investigator Meetings and writing of Clinical Study Reports

• Develop comprehensive study reports outlining Group research and activities for appropriate Schering-Plough Medical Affairs follow-up

• Proactively identify and elevate critical study issues; (e.g., vendor issues, drug supply, enrollment and study initiation through study close out)

• Respond to protocol queries and enrollment eligibility questions

• Systematize and direct operational aspects of the study, ensuring adherence to timelines

• Address risk management issues through a contingency plan

• Assist with SAE information, collection, and review for accuracy and completeness, and conduct query resolution and routing

• Liaise with Data Management on the monitoring of study data from Clinical Personnel

• Assist with the writing of Clinical Protocols and CRF design

• Therapeutic area of concentration: Hepatology/Gastroenterology- Phase III

Johnson & Johnson

1/2005 – 4/2006

Consultant - Global Clinical Registry Process Associate/Global Clinical International Monitor

Ensured the data integrity of the clinical registry and associated external websites through a flawless execution of the processes

• Maintained websites and effectively collaborated with all members of the clinical registry team worldwide

• Created patient recruitment plans, tracking and reporting strategy's to ensure adherence to procedures; protocols and project plans in accordance with FDA regulations and ICH guidelines

• Identified potential gaps within J&J's current clinical trial portfolio; per disease state and indication, that were relative to Cooperative Group interest and timing

• Liaised with Finance in the establishment of the management of study contracts, budgets and budget negotiations globally, with outside vendors

• Monitored and maintained the generation, distribution and upload of weekly clinical registry notifications/forms to 80 countries worldwide

• Monitored and maintained the generation of XML files and transfer data to Veritas Medicine for disclosure for 100 – 200 disclosures per year

• Assisted in the tracking and analysis of metrics; and development of status reports, SOP revisions and document quality control

• Conducted Trial Master File Reconciliation and analysis on all essential regulatory study documents; that ensured the data integrity of the clinical trial

• Updated status reports to provide transparency across the process

• Assisted with the clinical adjudication reporting and integration of protocol amendments

• Supported new customer service for managing consumer queries related to enrollment in a clinical study that is posted to the external registry

• Provided essential information on human medicinal products to support EudraVigilance Medicinal Product Dictionary requirements

• Provided clinical trial information for EudraCT to assure consistency in reporting through the proposed EuroPharm database

• Provided benefit risk management with a directory of studies and related safety procedures that were being followed

• Reviewed Case Report Forms for accuracy and completeness and conducted query resolution

• Provided Data management with the ability to reference a consolidated view of the status of clinical studies registration and reported activities across the enterprise

• Facilitated future integration with other J&J business processes; to develop, negotiate and monitor contractual milestones and trial budgets

• Therapeutic area of concentration: Infectious Disease and Cardiovascular- Phase’s III and IV

Bristol-Myers Squibb Company

7/2000 – 12/2004

Consultant - Clinical Study Coordinator

• Interacted with investigators, project managers and sales personnel to provide controlled access to records and proprietary information as requested by authorized BMS staff worldwide

• Supported the protocol review committee and clinical action team with all relative study documents

• Assisted with the integration of minutes into protocol and informed consent draft documents

• Organized and facilitated global and domestic clinical team kickoff meetings

• Assisted in the planning sessions and study development process

• Assisted with the implementation and development of trial monitoring plans, managed enrollment strategies with CRAs and Site Study Coordinators; and facilitated cross-functional medical meetings on trial levels

• Received, indexed, archived and processed clinical trial records in accordance with BMS documented procedures

• Maintained document management database systems to ensure future efficient electronic retrieval of all records

• Performed tasks in accordance with regulatory requirements to meet quality control standards

• Maintained independent, competitive research and developmental goals; by providing the clinical and business planning including; metric reports, milestones, capacity and accountability model, resource estimation processes, tracking and forecast update reports

• Knowledge of SSRs and SOPs in accordance with worldwide regulatory affairs

• Monitored trial spending against forecast and manage clinical trials supplies forecasting, review packaging, manage supply release and shipping to clinical trial sites in compliance with BMS SOP's

• Contributed to the development, issue and maintenance of procedures and systems

• Audited study sites and performed a master file study reconciliation

• Partnered with clinical teams to draft and implement clinical trial protocols

• Worked with ClinTrace, ClinTrial and Oracle/SQL databases

• Therapeutic area of study: Diabetics Phase IV

EDUCATION:

DeVry University

Bachelor of Science Degree, Network Communication Management May 2004

Certified Clinical Research Associate

October 2005

Certified IT Project Coordinator & Tester Impetus Systems June 2005

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