Key Responsibilities:<\/p>\n
Clinical Operations:<\/p>\n
Manage clinical vendors (including on-site monitors \/ CRO) and oversee relevant sections of the Protocol Management Plan. Responsibilities include, but are not limited to the following activities:<\/p>\n
\t\tLead point of contact for clinical vendors
\n\t\tSupport vendor selection and contracting
\n\t\tTrain vendors
\n\t\tMonitor vendor performance against contract, ICH GCP, relevant SOPs, local Regulatory and ethical standards and protocol; includes site visit report review and quality oversight visits.
\n\t\tTrack vendor invoices for accuracy and against contract and send invoices for processing and payment.<\/p>\n
\tProvide initial and ongoing training to other departments and site staff to support the conduct of clinical trial activities.
\n\tConduct risk planning and mitigation for vendors and clinical activities working with CTMs (Clinical Trial Managers) to mitigate risks and solve issues.
\n\tReview, provide input, and draft assigned sections of key study documents.
\n\tEnsure approved monitoring plan is in place.
\n\tDevelop quality oversight plan for monitoring activities.
\n\tAssist CTM in establishing study timelines and budgets for clinical aspects of trials and ensure clinical activities are conducted within timelines and budget.
\n\tManage and oversee the completeness and accuracy of the Trial Master File (TMF) through appropriate reviews of all study related information, while ensuring TMF is inspection ready.
\n\tWork with CTM and other departments to oversee data quality through various means including data listings reviews. \u00a0
\n\tPrepare for and conduct site visits as needed, including site qualification, study initiation and Quality Oversite visits.
\n\tProvide study status updates to project team and management as needed.
\n\tAct as clinical operational lead on observational studies as assigned.
\n\tOversee studies that IAVI monitors for other sponsors.<\/p>\n
\u00a0<\/p>\n
Departmental and knowledge development activities:<\/p>\n
\tParticipate in\/initiate Clinical Development departmental activities as assigned (e.g., drafting\/reviewing operational procedures, participating in departmental meetings, etc.)
\n\tProvide support and back-up to senior departmental personnel as needed, such as attending meetings, assuming lead in study team meetings or ad-hoc meetings, generating and\/or reviewing minutes, and following up on action items.
\n\tRemain up to date on knowledge of clinical trial methodology, ICH GCP, FDA regulations, EMA Regulations, and other local\/international regulatory and ethical guidelines and requirements.
\n\tRemain abreast of scientific knowledge of targeted disease and population and investigational product(s).
\n\tParticipate in training activities for new staff, as needed.
\n\tPerform other duties as assigned.<\/p>\n
Education and Work Experience:<\/p>\n
\tBachelor\u2019s degree in a scientific or related field is required.
\n\tMinimum 4 years of clinical trials experience including clinical monitoring experience is required; Minimum of 6 years\u2019 clinical trial experience required for Senior COS.
\n\tClinical team lead experience is preferred for COS; Clinical Team Lead experience is required for Senior COS.<\/p>\n
Qualifications and Skills:<\/p>\n
\tExperience conducting presentations of technical information concerning specific projects is required.\u00a0
\n\tInterpersonal skills and ability to work effectively in a cooperative and collaborative manner with all levels, and across functional teams both internally and externally is required.
\n\tAbility to work on problems of moderate complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action is required.
\n\tProject planning and implementation skills in a cross-disciplinary and multi-cultural team are required.
\n\tExcellent knowledge of ICH GCP and FDA CFR guidelines as well as the Declaration of Helsinki and relevant country specific regulations are required.
\n\tExcellent oral and written communication skills are required.
\n\tProven ability to coordinate and lead multi-disciplinary project teams is required.
\n\tA professional demeanor, as well as a pleasant manner and positive \u201ccan-do\u201d attitude.
\n\tFlexible and adaptable to accommodate changing deadlines to meet organizational needs is required.
\n\tExcellent computer skills and proficiency in Microsoft Word and Excel is required.
\n\tAbility to travel up to a maximum of 50% of the time occasionally is required.
\n\tHigh level of independence in performing responsibilities is highly desirable.
\n\tAbility to mentor other staff including Clinical Trial Associates and Clinical Research Associates is highly desirable.
\n\tFamiliarity with emerging infectious diseases and managing trials in West Africa.<\/p>\n
Apply Through:<\/p>\n
recruiting.ultipro.com<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"http:\/\/recruiting.ultipro.com","_company_name":"International AIDS Vaccine Initiative (IAVI)","_company_website":"http:\/\/www.iavi.org","_company_tagline":"The International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS.","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[692],"job-categories":[773,693,714],"job-types":[687],"class_list":{"0":"post-92540","1":"job_listing","2":"type-job_listing","3":"status-publish","4":"hentry","5":"job_listing_region-nairobi","7":"job-type-full-time"},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/job-listings\/92540","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/users\/2"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/media?parent=92540"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/job_listing_region?post=92540"},{"taxonomy":"job_listing_category","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/job-categories?post=92540"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/job-types?post=92540"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}