Sub-Saharan AfricaRole SummarySub-Saharan Africa

Sub-Saharan AfricaThe Site Care Partner is the main Client point of contact for investigative sites throughout a study life cycle; accountable for site start-up activities through activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies; accountable for site-level recruitment and operational success, and accountable for safeguarding the quality and patient safety at the investigator site. The Site Care Partner contributes to country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and Client pipeline opportunities under supervision. The Site Care Partner is the “face of Client” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and Client’s reputation is upheld throughout study lifecycle. Additionally, the Site Care Partner will coordinate with other roles and functions that will interface with study sites (eg. Study Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) thereby, optimizing communications and enhancing overall visibility into and confidence of quality of site level activities. The Site Care Partner is responsible for site oversight utilizing and interpreting data from analytic tools, in conjunction with country intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.Sub-Saharan Africa

Sub-Saharan AfricaResponsibilitiesSub-Saharan Africa

Sub-Saharan AfricaAccountable for site start-up and activation:Sub-Saharan Africa

• Sub-Saharan AfricaDeploy GSSO site strategies by qualifying and activating assigned sitesSub-Saharan Africa
• Sub-Saharan AfricaSupports processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection.Sub-Saharan Africa
• Sub-Saharan AfricaCollaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable) under supervision.Sub-Saharan Africa
• Sub-Saharan AfricaMaintain a thorough knowledge of assigned protocolsSub-Saharan Africa
• Sub-Saharan AfricaConduct study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation.
• Sub-Saharan AfricaEnsure all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation. (e.g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc.)Sub-Saharan Africa
• Sub-Saharan AfricaSupport country specific ICD review and deployment when applicableSub-Saharan Africa
• Sub-Saharan AfricaEnsure follow up activities completion post PTA and SIV to ensure site readiness for FSFV
• Sub-Saharan AfricaPartners with site monitor to ensure site monitoring readiness in anticipation of first subject first visitSub-Saharan Africa
• Sub-Saharan AfricaResponsible for relationship building and operational oversight of the siteSub-Saharan Africa
• Sub-Saharan AfricaProvide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts. (e.g., vendor, site contracts and payment issues etc.)Sub-Saharan Africa
• Sub-Saharan AfricaEnsure the strategy/approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the studySub-Saharan Africa
• Sub-Saharan AfricaBe accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators.Sub-Saharan Africa
• Sub-Saharan AfricaMaintain regular communications with investigator sites to gather status updates and drive delivery to study goals (e.g. recruitment, data entry timelines etc.).Sub-Saharan Africa
• Sub-Saharan AfricaPartner with local RA/ CTRO / SAP to ensure timely completion on country / local registry when applicableSub-Saharan Africa
  
  

Sub-Saharan AfricaAccountable for study conduct and close-outSub-Saharan Africa

• Sub-Saharan AfricaAct as operational point of contact for all site-level questions, liaising with and escalating to appropriate teams to respond and resolve questions.Sub-Saharan Africa
• Sub-Saharan AfricaReview Site Monitoring ReportsSub-Saharan Africa
• Sub-Saharan AfricaSupport the site with revision and submission of ICD documents (and amendments).Sub-Saharan Africa
• Sub-Saharan AfricaWorking with other roles, maintain system management (e.g., EDC , Shared Investigator Platform, Site Profile and other systems as applicable) at site level ensuring alignment across platforms.Sub-Saharan Africa
• Sub-Saharan AfricaDuring the conduct of the study, the Site Management Organization Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed under DCSO/ Senior SCP supervision. In addition, the SMO Assessment is reviewed and updated when major staffing, contracting, or other significant site changes/issues occur to confirm that continuity and contingency plans are current.Sub-Saharan Africa
• Sub-Saharan AfricaReview and manage site practices that differ from Client practices and liaise with study management and Business Process Owners as needed.Sub-Saharan Africa
• Sub-Saharan AfricaMaintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.Sub-Saharan Africa
• Sub-Saharan AfricaOversight and management of site deliverables to study targets, i.e. data cuts/sweeps, interim analyses, database locks, helping to oversee data is up to date and any other site-facing deliverables, i.e. investigator signatures.Sub-Saharan Africa
• Sub-Saharan AfricaFollow the study oversight plan and proactively put in place mitigations for known/anticipated risks.Sub-Saharan Africa
• Sub-Saharan AfricaSupport development and delivery including issue resolution of decentralized capabilities at investigator sites e.g. home health, ePRO, DTP etc.Sub-Saharan Africa
• Sub-Saharan AfricaAssure quality and consistency in the delivery of monitoringSub-Saharan Africa
• Sub-Saharan AfricaDrive monitoring efficiencies and best practices for study/region/programSub-Saharan Africa
• Sub-Saharan AfricaSupport shaping the local clinical development environment with a goal to enhance Client reputation in scientific leadership.Sub-Saharan Africa
• Sub-Saharan AfricaMay act as a Subject Matter Expert on Client systems and processes.Sub-Saharan Africa
• Sub-Saharan AfricaActively pursue possible efficiencies and develop best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/site satisfaction and strengthen site relationshipsSub-Saharan Africa
• Sub-Saharan AfricaEnsures clear and open communication with Study Operations ManagerSub-Saharan Africa
• Sub-Saharan AfricaSupport the site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Country Trials Manager and Study Management.Sub-Saharan Africa
  
  

Sub-Saharan AfricaResponsible for proactively providing local intelligence

• Sub-Saharan AfricaProvide input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics.Sub-Saharan Africa
• Sub-Saharan AfricaProvide support to the Study Operations Manager/Global Study Manager to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies.Sub-Saharan Africa
  
  

Sub-Saharan AfricaQualificationsSub-Saharan Africa

Sub-Saharan AfricaTraining and Education

• Sub-Saharan AfricaBachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5 years experience)Sub-Saharan Africa
• Sub-Saharan AfricaProficiency in local language preferred. English is requiredSub-Saharan Africa
  
  

Sub-Saharan AfricaPrior ExperienceSub-Saharan Africa

• Sub-Saharan AfricaDemonstrated experience in site management with prior experience as a site monitorSub-Saharan Africa
• Sub-Saharan AfricaDemonstrated experience in start up activities through to site activationSub-Saharan Africa
• Sub-Saharan AfricaDemonstrated experience in conduct and close out activitiesSub-Saharan Africa
• Sub-Saharan AfricaDemonstrated knowledge of quality and regulatory requirements in applicable countriesSub-Saharan Africa
  
  

Sub-Saharan AfricaTechnical CompetenciesSub-Saharan Africa

• Sub-Saharan AfricaKnowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirementsSub-Saharan Africa
• Sub-Saharan AfricaMust demonstrate good computer skills and be able to embrace new technologiesSub-Saharan Africa
• Sub-Saharan AfricaGood communication, presentation and interpersonal skillsSub-Saharan Africa
• Sub-Saharan AfricaAbility to manage required travel of up to 75% on a regular basisSub-Saharan Africa
• Sub-Saharan AfricaDemonstrated networking and relationship building skillsSub-Saharan Africa
• Sub-Saharan AfricaDemonstrated ability to manage cross functional relationshipsSub-Saharan Africa
• Sub-Saharan AfricaAbility to communicate effectively and appropriately with internal & external stakeholdersSub-Saharan Africa
• Sub-Saharan AfricaAbility to adapt to changing technologies and processesSub-Saharan Africa
• Sub-Saharan AfricaKnowledge of country requirements for GCP that may be different to those of Client ProceduresSub-Saharan Africa
  
  

Sub-Saharan AfricaBehavioral CompetenciesSub-Saharan Africa

• Sub-Saharan AfricaEffectively overcoming barriers encountered during the implementation of new processes and systemsSub-Saharan Africa
• Sub-Saharan AfricaIdentifies and builds effective relationships with investigator site staff and other stakeholdersSub-Saharan Africa
• Sub-Saharan AfricaEffective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organizationSub-Saharan Africa
  
  

Sub-Saharan Africa