Project Management Manager

Afolabi, Omowunmi https://www.linkedin.com/in/omowunmiafolabi/

***************@*****.***

CAREER PROFILE:

A versatile leader with over 16 years of combined experience, managing large-scale projects and programs in rural and underserved communities, working with the government, academic institutions, not-for-profit organizations, and community-based organizations. Demonstrated expertise in good clinical practice, HIPAA compliance, data integrity, reporting, and good use of EPIC, eREG, Oncore, Redcap, and Medidata Rave. Adept in project management, coordination, and interrelating with a multi-center study team of physicians, research nurses, data analysts, laboratory scientists, sponsors, CROs, and regulatory agencies. I have documented success in communication management, budget negotiation, protocol preparation, and review, developing SOPs, informed consent, and SAE report. I possess strong critical thinking, problem-solving, and excellent communication skills working with multicultural teams and stakeholders with exposure to complex, global operations. Experienced in managing studies from start-up to close-out. Specialized in Phase I-IV trials, focusing on Oncology and Nephrology.

EDUCATION

2023 Divine Mercy University (MSc in Leadership Psychology in view) 2020 University of Washington (Leadership and Management in Health) 2020 University of Washington (Project Management in Global Health) 2017 Collaborative Institutional Training Initiative 2017 National Institutes of Health (NIH) Office of Extramural Research 2012 USAID Global Health E-Learning Centre

2008 Nigeria Institute of Management

2007 Yaba College of Technology, Yaba Lagos (HND Civil Engineering) CORE COMPETENCE AND RELEVANT TECHNICAL SKILLS

Value-based leader Leadership and Management Project Management Skills Others Self-starter Communication Skills Team Management Good Clinical Practice Leading others Managing Partners Risk Management Strategy and implementation Technological Awareness Negotiation Contract Management Report writing Problem-Solving skills Community Mobilization Cost control Resource planning & Allocation Creative & Innovative Report writing Monitoring and Evaluation Operations Management Emotional Intelligence Stakeholder Engagement Change Management Data Management Systems Thinking Delegating Quality assurance Facilitation / Presentation Skills EXPERIENCE

Clinical Trial Project Manager

Yale University School of Medicine.

September 2022 – Present

Provide project management, and project coordination for three (3) Disease Aligned Research Teams at the Yale Cancer Center:

Supports the growth and development of the Yale Cancer Center (YCC) Clinical Trials Office (CTO) by overseeing the implementation, advancement, and growth of Yale’s offering of high-quality trials to its faculty and patients.

Ensures studies are activated to support the core mission of the Cancer Center to enhance, strengthen, and increase the institution’s ongoing cancer research to reduce cancer incidence, mortality, and morbidity.

Responsible for assigned research infrastructure development, oversees trial activation and related projects, communicates status and improvement areas to leadership, and works with the leadership team to plan, develop, and implement new strategies to improve the timeliness and accurate execution of clinical trials. Other Responsibilities:

Sub-Committee Member

Diversity, Equity, Inclusion, and Belonging (DEIB)

- Played a pivotal role in establishing and supporting employee resource groups (ERGs) within the Clinical Trials Office (CTO)

- Collaborated with the Human Resources team to review and enhance recruitment strategies, ensuring a diverse and inclusive talent pipeline.

Co-Chair Mentoring Sub-Committee

Future Leaders of YALE

- Designed a structured mentorship program to connect experienced professionals with emerging leaders at YALE

- Implemented strategies to promote inclusive practices and create a welcoming environment for all mentors and mentees.

- Fostered networking opportunities and facilitated meaningful connections between mentors and mentees Program Manager

University of Chicago Medicine

May 2022 – August 2022

Provide on-the-ground, center-level oversight, project management, project coordination, and clinical monitoring for the section of Nephrology and the Institute of Population and Precision Medicine.

Manage multiple clinical trial projects (Phase I-IV)

Provide management and auditing services for electronic Trial Master Files (eTMFs) from study inception through study closure in collaboration with CROs and other vendors.

Engage faculty members, sponsors, and CROs in close communication to ensure clinical trial success

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

Incorporate GCP compliance into each trial by assisting clinical staff with site query resolution, reducing protocol deviations, writing/following SOPs, and auditing study procedures.

Collaborate with CROs and other vendors to manage study electronic Trial Master Files (eTMFs) from study inception to study closure, including audits as needed.

Coordinate the activation and maintenance of clinical protocols, including review and completion of submissions, amendments, and adverse event reports as required by the UChicago Institutional Review Board (IRB).

Act as a liaison with medical staff, university departments, ancillary departments, and satellite facilities.

Facilitate regular communication with Principal Investigators, Sub-investigators, Director of Operations, Database Manager, Research Administration personnel, and personnel across all collaborative institutions.

Accountable for high standards of good clinical research practice

Implements Good Clinical Practices (GCP) and all relevant current local, state, and federal laws, regulations, policies, and procedures.

Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.

Train research Study teams on study protocols

International Project Manager

University of Kansas Medical Center (H3Africa Clinical Research Network Case-Control and Cohort Projects) June 2020 – February 2021

Responsible for project management, project coordination, and clinical monitoring for the NIH-funded multi-center cohort and case-control studies in 24 Clinical centers in 8 countries across sub-Saharan Africa

Responsible for providing technical and managerial support to clinical centers at the State, National, and international levels

Effectively communicate with the Ethics Board for clinical study approvals, amendments, and continuations.

Maintain study logs and documentation for reporting and review purposes.

Conduct ongoing site monitoring visits and prepare detailed monitoring visit reports.

Served as a member of the Steering committee for manuscript publication. National Project manager

University of Arizona (H3Africa Clinical Research Network Case-Control and Cohort Projects) May 2017 – May 2020

Responsible for project management, project coordination, and clinical monitoring for the NIH-funded multi-center cohort and case-control studies in 18 Clinical centers in sub-Saharan Africa

Managed a cross-functional team of 185 in eight countries (Nigeria, Ghana, Ethiopia, Uganda, Cameroun, Kenya, Tanzania, and Cape Town,) ranging from Principal Investigators, Research Nurses, and Laboratory scientists, and collaborated with researchers from NIH, Harvard University, Duke University, University of Toronto, University of Michigan, Loyola University.

Set up 13 clinical centers in 3 months and trained over 90 research nurses and admin staff.

Enrolled 90% of target study participants in 3 years against the 5-year mark.

Organized annual investigators’ meetings with over 150 participants from 10 different countries over the space of 3 years.

Ensures study compliance with regulatory requirements, including amendments, continuing reviews, and IRB submissions.

Monitor clinical sites for compliance with GCP and ICH guidelines, including completion of regulatory documents and proper completion of case report forms

Effectively communicate with the Ethics Board for clinical study approvals, amendments, and continuations.

Coordinate the acquisition, shipping, and distribution of research equipment, supplies, and services to H3Africa Clinical Sites.

Maintain study logs and documentation for reporting and review purposes.

Conduct ongoing site monitoring visits, and prepare detailed monitoring visit reports

Screen all adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reported to the study sponsor and all participating site IRB Management Consultant /Lead Project Manager

BudgIT

September 2016 – February 2017

Provided leadership to a team of over 30 people in the fight for transparency in the Nigerian budget.

Coordinated the change management process, reviewed staff policies, financial and administrative management, and standardization of policies.

Co-hosted seminars created content for animated videos and curated tweets on the cost of corruption under the Access Nigeria project. This project focuses on the accountability and transparency of the Nigerian Justice and security sector.

Played an instrumental role in the Nigerian government joining the Open Government Partnership (OGP) and working through the Open Alliance.

Coordinated all external communications, press releases, and all other communication channels of the organization.

Monitoring, tracking, and supervision of 16 project field officers who track constituency projects across different states in Nigeria.

Reviewed and analyzed community development and Health and Education related projects.

Providing feedback and progress reports to the senior management team Southwest Project Director / Conditional Cash Transfer Technical Assistant NATIONAL PRIMARY HEALTHCARE DEVELOPMENT AGENCY NIGERIA April 2012 – March 2015

Project: Subsidy Re-investment Empowerment Conditional Cash Transfer Programme (SURE-P Maternal and Child Health CCT program) Providing leadership for the Programme at the Federal, State, local, and ward levels and working in close collaboration with State staff, Primary health staff, and international partners:

Stakeholder engagement and advocacy visit

Served as the Secretary of the State Steering Committee

Overall coordination of the CCT Programme in the 6 geo-political States in Nigeria (1000 primary healthcare centers across the 36 states and the capital Abuja)

Developed tools and products used in the field.

Monitoring, tracking, and supervising the implementation of the CCT Programme

Facilitate the prompt resolution of any operational, bureaucratic, or logistic challenge that arises during program implementation.

Monthly report of all activities in the field /ensuring adherence to project needs and validation of data collected from various Primary Health care centers each month.

Capacity building and supervision of state staff.

Strengthening linkages for social support between women, men, families, and communities and the healthcare delivery system.

Working with banks and mobile money agents to ensure that women who qualify for cash support are dully paid.

Facilitation, monitoring, and supervision of facility and community-based program activities, and of learning activities such as interviews & focus group discussions

Research / Programme Analyst

FEDERAL MINISTRY OF HEALTH NIGERIA [Office of the Minister of State for Health] September 2011- April 2012

As a member of the delivery unit team, I co-created the National concept note for the Subsidy Re-investment Empowerment Conditional Cash Transfer Programme (SURE-P Maternal and Child Health CCT program)

Finalized project design, schedule, and budget.

Proof of concept and pilot testing of project design

Arranged recruiting of field staff/ consultants.

Developed screening questionnaire(s), fieldwork plan, and instructions for all consultants.

Monitored recruiting progress and check respondent profiles.

Developed discussion guide(s) and capacity training for consultants.

Conducted interviews, Focus group discussions, and observational sessions, across six geopolitical zones

Debrief with the team at intervals during the implementation of the project.

Analyzed results and prepare deliverables previously agreed upon. Program Officer

Educational Aid Global Initiative

November 2009 – April 2011

Designed strategic Programs used to achieve organizational goals: Restore a school, Sponsor a child, Mentor /Tutor a child, and Resources for learning.

Drafted agendas of all meetings in consultation with the general coordinator and took minutes of all such meetings.

Assisted with all aspects of administrative management, directory maintenance, logistics,

Resolved all day-to-day administrative and operational problems

Maintains a good working relationship with all categories of partners (Financial partner, resource partner and volunteer partner) Class Teacher Government Secondary School

NATIONAL YOUTH SERVICE CORPS

October 2008- September 2009

Project Manager (MDG WASH Project)

ARCHON NIGERIAN LIMITED

November 2007- September 2008

Responsible for providing strong leadership to assigned consultants across the South west political Zone in Nigeria:

Develop and implement an appropriate and effective WASH strategy, setting clear objectives and indicators, for WASH activities in consultation with other WASH staff and field managers, and, where appropriate, with the local communities.

Manage the assigned WASH project(s) to meet the project objectives within budget and allotted time frame.

Monitoring, evaluating and supervising WASH activities, overseeing the technical design, execution and evaluation of progress through outputs and impacts using both quantitative and qualitative data.

Provide input into the integration of beneficiary participation and accountability in all aspects of the project.

Ensure accurate and timely reporting of activities according to, donor and other applicable timeframes and formats.

Hygiene promotion and education in communities where projects are being implemented

Capacity building of partners

Engineer Trainee

STUDENT INDUSTRAL WORK EXPERIENCE SCHEME (SIWES)

2004

CERTIFICATION

Project Management in Global Health

Leadership and Management in Health

Good Clinical Practice (GCP)

Responsible Conduct of Research

Data and Safety Monitoring in Human Subject Research

Human Subjects Research

Health Information Privacy and Security (HIPS)

Essentials of Research Administration

Emotional Intelligence

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