Natasha Bullett-Afriyie ,MSL
Senior Clinical Trial Associate @ ICON plc
About
Clinical research and project management professional with 10+ years of leadership experience and 5+ years supporting global clinical trials across Phase I-IV studies. Experienced in clinical operations, site start-up, TMF management, regulatory compliance, vendor oversight, and cross-functional project execution. Passionate about improving trial efficiency, developing teams, and creating operational excellence within clinical research. In addition to my work in healthcare, I serve as Executive Director of Nurturing Futures Honoring Heritage Academy, where I lead initiatives focused on education, mentorship, scholarships, and community impact. Areas of expertise include: • Clinical Operations • Project Management • Regulatory Compliance • Site Start-Up & Activation • Veeva Vault • TMF/eTMF Oversight • Vendor Management • Team Leadership • Process Improvement
United States
Greater Philadelphia
Pharmaceuticals
Clinical Research, Regulatory Affairs, Team Leadership, ICH, Attention to Detail, Site Identification, Operational Strategy, Binders, Informed Consent, Data Entry, Electronic Data Capture (EDC), Presentations, Organization Skills, Trial Master File (TMF), Contract Research Organization (CRO), Remote Monitoring, Vendor Management, Clinical Trial Management System (CTMS), Clinical Development, CTM
Experience

Lead Clinical Trial Associate
PM Scope: 2–5 concurrent global Phase II–III studies | 30–60 sites | 10–20 cross-functional team members • Directed trial operations for 2–5 global Phase II–III studies, leading eTMF strategy and sustaining 95% inspection readiness in support of sponsor and regulatory audits. • Owned study timelines and deliverables in partnership with sponsors and cross-functional teams, resolving operational barriers and improving milestone adherence by 15–20%. • Oversaw site management activities for 30–60 global sites, strengthening feasibility outcomes and accelerating site activation timelines by up to 25%. • Reviewed and approved vendor invoices; partnered with Finance and Legal to ensure contract alignment and cost control, maintaining budget variance within 3–5%. • Led cross-functional project teams (10–20 members), facilitating governance, communication, and compliance across Clinical Operations, Data Management, Regulatory, and Biometrics. • Developed and maintained detailed project plans and trackers to improve operational predictability across 3+ concurrent studies; escalated risks and issues to drive timely resolution. • Supported site selection, initiation, and readiness for 20–40 sites by streamlining document collection and improving communication pathways.

Lead Clinical Trial Associate
Lead eTMF and collection of regulatory documents and development of assigned study-related documents Participate in all phases of clinical trial site management from start-up, through maintenance and close out activities Responsible for collection of essential documents and maintenance of both paper and electronic Trial Master File Works with cross-functional team to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, project plans, ICH/GCP guidelines and government regulations Assist with feasibility and startup activities Onboarded new temps by entering employee information into systems

Associate Project Manager
Strongbridge Biopharma plc
Coordinate vendor/consultant/supplier contracts (NDAs, SOWs, and Agreements) in collaboration with subject matter experts and legal. Track spending against budget via contracts and invoices in close coordination with finance. Oversee Action, Decision, and Issues log of select R&D clinical programs and follow up with internal stake holders on progress. Creates and monitors project timelines and/or budgets as needed.

Project Coordinator
MedAvante-ProPhase
New Jersey
▪ Act as initial point of contact for investigative site inquiries regarding MA-PP study specific projects ▪ Independently investigates, resolves or escalates issues to the appropriate internal team members. ▪ Collaborates with internal departments, such as Project Management, IT and Clinical Trial Services to create internal Site Management working documents (i.e. project specific addendums) and external site/client facing documents ▪ Update, track, and maintain study-specific trial management tools / systems. Set-up and maintain study files (study specific, investigator, etc.) ▪ Conducts MA-PP site management activities, including site activation, site training and issue resolution, ensuring highest customer satisfaction- Work in conjunction with CRA to complete site activation and start up, maintenance, and study close out ▪ Guides site raters through MA-PP training process from initial rater qualification to training completion. ▪ Serves as subject matter expert on internal systems and works with MA-PP clinicians on rater training and qualification for investigative sites and project activities (this may include but is not limited to managing site rater training or assessment activities.) ▪ Provides exceptional and timely external customer service by determining requirements, answering inquiries, researching and exploring issues to resolution, escalating the issues as needed, and maintaining internal issue management application. ▪ Train investigative sites on MedAvante study procedures. ▪ Provide timely status reports to internal and external key stakeholders

Senior Project Coordinator
Develop and maintain an in depth knowledge of Client’s product line, pricing structures, and various channel strategies -supply chain operations • Perform wholesaler and distributer relationship management • Coordinate with Product Strategy and Marketing Teams to ensure project completion • Manage diverse channel customers while remaining focused on quality and compliance • Educate clients and field in areas such as registration, policies, and e-commerce

Project coordinator
Trenton, New Jersey
Healthcare Enrollment /Case management/ training / developing training material for the department of health care and treatment STD program RESPONSIBILITIES: 1. Provide enrollment assistance (including but not limited to completing coverage applications, gathering required documentation and troubleshooting the enrollment process) for uninsured children and adults to access subsidized, low-cost and free health insurance programs through the health insurance marketplace, Medicaid and the Children’s Health Insurance Program (CHIP). 2. Provide structured patient education on health coverage, engage in follow-up conversations and offer renewal assistance for enrolled individuals. 3. Distribute outreach materials to patients, community members, partner organizations and businesses to build coverage option awareness. 4. Develop, discover and attend community events in order to promote coverage options and the mission and services of the organization. 6. Collaborate with various local organizations to build awareness of coverage options, spur enrollment, and build referral linkages. 7. Attend and successfully complete all required training programs and participate in ongoing conference calls, webinars, and other professional development opportunities. 8. Accurately provide required reporting to track goal achievement and client satisfaction. 9. Recruit and utilize volunteers to increase program capacity. 10. Assist in the development and implementation of organizational outreach and enrollment initiatives. 11. Other duties as assigned.

Employee Benefits Specialist
Greater Philadelphia Area
-Perform, track and log all transactions performed related to Human Resources and/or Benefits Administration -Understand, apply and communicate conceptual elements of Benefits and/or Human Resources rules, regulations and help other team members as requested. -Handle confidential information with sensitivity and discretion in accordance with Data Privacy requirements & HIPPA -Track and manage cases for user resolution - Provide extensive knowledge on medical, dental, and vison plans

Supervisor
• Reviews and analyzes new claims for accuracy and eligibility • Initiate authorizations for various medical procedures • Liaison between nurses and facilities; for updates concerning members and hospitalizations • Review medical claim policy to determine if pre-certification is required • Proficient with standards involving Medicaid, Medicare A&B, HIPPA, URAQ, HEDIS and NCQA • Medical Coding and billing • Train and supervise between 10-15 new hires • Monitor Call center and individual KPIs • Monitor calls for to ensure division performance and company standards are being upheld • Assisted management in identifying areas of improvements for team members • Collaborated on a Yearly HEDIS Audits ; Chart review and abstractions • Maintained Updates with team via Share Point

Senior Managed Care Coordinator
Greater Philadelphia Area
• Reviews and analyzes new claims for accuracy and eligibility • Initiate authorizations for various medical procedures • Liaison between nurses and facilities; for updates concerning members and hospitalizations • Review medical claim policy to determine if pre-certification is required • Proficient with standards involving Medicaid, Medicare A&B, HIPPA, URAQ, HEDIS and NCQA • Medical Coding and billing • Prior authorizations for LTC
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