Edward Sobe

• Providing oversight for clinical operations in West Africa Region
• Oversee CRA performance and deliveries on projects
• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development, rewarding and disciplining employees, and addressing employee relations issues and resolving problems.
• Provide leadership and delivery of clinical studies within the West Africa region.
• Manage quality of assigned staff’s clinical work through regular review and evaluation of work product.
• Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
• Collaborates with other clinical teams and other functional leadership to manage project related challenges and to achieve exemplary customer service.
• Participates in corporate or organizational departmental quality or process improvement initiatives.
• Established and maintained operational standards.
• Develops strong relationships with current clients to generate new and/or add-on business for the future. Participate in bid defense meetings.

• Providing oversight for clinical operations in West Africa sub-region
• Perform Accompanied Site and Focus visit to assess CRA performance and deliveries on projects
• Participant in bid for project by providing local insight on capabilities of our company
• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include
  planning, assigning, and directing work, assessing performance and guiding professional development,
  rewarding and disciplining employees and addressing employee relations issues and resolving problems.
• Participate in selection for hiring new employees by conducting candidate review and participating in interviewing process. Onboarding and training of new employees.
• Ensure that staff has proper materials, systems access and training to complete job responsibilities.
• Provide oversight for execution of training plan, SOP review and training experiences, as applicable.
• Perform allocation of resources to clinical research projects by assigning staff to clinical studies based on
  their experience and training.
• Manage quality of assigned staff’s clinical work through regular review and evaluation of work product.
• Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct
  deficiencies in performance of staff.
• Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of
  findings as outlined by clinical operations management.
• Collaborates with other clinical teams and other functional leadership to manage project related challenges
  and to achieve exemplary customer service.
• Participates in corporate or organizational departmental quality or process improvement initiatives.
• Leading engagement with sub-regional regulatory authorities and providing insights on regulatory landscape
  to ensure predictability of study timelines.

• Conducted Site Initiation, monitoring, and close-out visits in accordance with contracted scope of work and good clinical practice for the below studies meeting sponsor database lock timeline.
  - Phase III, randomized, double-blind, active, controlled, multinational, multicenter, non-inferiority trial using carbetocin room temperature stable (rts) for the prevention of postpartum hemorrhage during the third stage of labour in women delivering vaginally
  - Phase IIb Study to Investigate the Efficacy of OZ439 & PQP Co-administered to Adults & Children with Uncomplicated P. Falciparum Malaria.
  - A Randomized, Observer-blind, Placebo-controlled, Two-part, Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Prime-boost Regimens of the Candidate Prophylactic Vaccines
  for Ebola Ad26.ZEBOV and MVA-BN-Filo
  - A Phase 2, multi-center, randomized, open-label, dose escalation study to determine safety of single (QD) and multiple (3 QD) doses of KAE609, given to adults with uncomplicated Plasmodium falciparum
  malaria
  - A Phase IIIb/IV comparative, randomized, multi-center, clinical study to assess the safety and efficacy of repetitive administration of Pyronaridine-artesunate, and Dihydroartemisinic-piperaquine versus Artemether
  lumefantrine or Artesunate-amodiaquine over a two-year period in children and adult patients with acute uncomplicated Plasmodium sp.
  • Conducted Site assessment and selection visits of investigator sites for the below studies for identification and qualification of investigator sites to participant in clinical trial.
  - A Multi-center, Phase I, Open-label, Single-dose Study to Investigate Pharmacokinetics (PK) of Ticagrelor
  in Infants and Toddlers, Aged 0 to less than 24 Months, with Sickle Cell Disease (HESTIA4)
  - A Phase 1 Randomized, Blinded, Placebo Controlled, Dose-Escalation and Dosing Regimen Selection Study
  to Evaluate the Safety and Immunogenicity of VSV-Vectored Lassa Virus Vaccine in Healthy Adults at Multiple Sites in West Africa (EBSILV-074-001)
  - A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of GBT440 administered Orally to Patients with Sickle Cell Disease
  - A Phase 3, Double-blind, Randomized, Placebo-controlled study of voxelotor (GBT440) in pediatric participants with sickle cell Anemia disease (Hope Kids 2).
  • Managing, monitoring quality, and ensuring overall protocol and process compliance for the following studies and achieved no direct finding for six (6) regulatory inspection conducted for the studies
  - Phase 2 interventional, multicentre, randomized open-label study to determine the effective and tolerable dose of KAF156 and Lumefantrine Solid Dispersion Formulation in combination, given once daily for 1, 2
  and 3-days to adults and children with uncomplicated malaria.
  - An epidemiology study to assess Plasmodium falciparum parasite prevalence and malaria control measures in catchment areas of two studies pre- and post RTS, S/AS01E introduction (EPI-MAL-002 and EPI-MAL003) to assess, in field conditions, vaccine benefit: risk in children in sub-Saharan Africa.
  - A Phase 2, multi-center, randomized, open-label, dose escalation study to determine safety of single (QD) and multiple (3 QD) doses of KAE609, given to adults with uncomplicated Plasmodium falciparum malaria
  - A cohort event monitoring study to define the incidence of diseases specified as protocol-defined potential adverse events of specific interest (AESI) and serious adverse events (SAE) in infants and children in Africa
  prior to implementation of the RTS’S/AS01E candidate vaccine.

• Overall management and coordination of all trial related activities including financial and study personnel.
• Created source documentation, developed site specific addendums for study protocols, and customized site-specific informed consent forms and other patient facing material.
• Training of field supervisor, field workers, study nurses on study protocol specific procedures, site
established standard operating procedures and data collection techniques.
• Creation of clinical quality Management system; drafted new standard operation procedures for IP
management, data management and clinical implementation process.
• Processing of ethic and regulatory submission as well as sponsor reports
• Generation progress quarterly and annual reports for EC and RA submission
• Coordinated and managed successful conduct of below clinical trials and epidemiological studies that has informed health policy in Ghana:
- Evaluation of impact of seasonal malaria chemoprevention on morbidity and mortality in young children in Northern Ghana.
- Immunogenicity of Human Rotavirus vaccine (Rotarix) at varying schedule, doses, and Ages in Rural Northern Ghana.
- A randomized double-blinded placebo-controlled trial to evaluate efficacy, safety, and immunogenicity
of two single doses of RRV-TV among neonates in rural northern Ghana.
- A randomized Double blinded placebo control trial to evaluate efficacy, safety, and immunogenicity of
3 doses of RotaTeq among Infants in Africa and Asia.
- Effectiveness of the monovalent rotavirus vaccine (Rotarix TM) against severe rotavirus diarrhea in Ghana.
- Longitudinal carriage survey on meningitis in the Kassena Nankana district.
- An integrated Maternal Neonatal and Child Health and Buruli Ulcer Control project in Upper Denkyira East Health Directorate which promotes the right to health of women, children under 5 and people affected by Buruli Ulcer
- Validation of report cards to measure the severity of gastroenteritis among infants in Africa and Asia.
- Communication for development (C4D project)-evaluation of a communication intervention aimed at improving maternal and child health in the three northern regions of Ghana.

• Performed site selection, investigator qualification, site initiation training and routine monitoring visit
including:
- Manage progress of study by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, data review, query generation and resolution: Study Title: Observational Study to Evaluate Clinical Safety After Introduction of Fixed Dose Artemisinin-Based Combination Therapy Eurartesim® (Dihydroartemisinin/Piperaquine [Dha/Pqp]) In Public Health Districts in Burkina Faso, Mozambique, Ghana and Tanzania.