Associate Local Start Up Manager, Ukraine - FSP

Job Overview:

At Covance, you’ll redefine what’s possible and discover your extraordinary potential. You’ll have the opportunity to personally advance scientific research and make a difference in peoples’ lives with your bold ideas and unique point of view. We are looking for a Associate Local Start Up Manager to be office based in Ukraine and working for one of our clients.

Responsibilities:Assistance with the ownership of country and site budgetsThrough continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market valueOversight and tracking of clinical research-related paymentsPayment reconciliation at study close-outResponsible for execution and oversight of clinical trial country submissions and approvals for assigned protocolsDevelopment of local language materials including local language Informed Consents and translationsWorks in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocolsResponsible for managing country deliverables, timelines and results for assigned protocols to meet country commitmentsContributes to the development of local SOPsWorks in close collaboration internally with Clinical country operations (CRD, CRM,CTC,CRA), Country Quality Manager (CQM), Finance, Medical Affairs, Regulatory Affairs, PharmacoVigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestonesCollaborates closely with Regional Operations to align country timelines for assigned protocolsProvides support and oversight to local vendors as applicableResponsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process managementEnters and updates country information in clinical, regulatory, safety and finance systems.Education/Qualifications:University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technologyIn lieu of the above requirement, candidates with proven relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be consideredThorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countriesThorough understanding of the drug development processFluent in local office language and in English, both written and verbalExperience:Good organizational and time management skillsWorking knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferredExcellent communication skills, oral and writtenSelf-motivation with the ability to work under pressure to meet deadlinesWorks well independently as well as in team environmentDetail and process orientedPositive attitude and approachInteract with internal and external customers with high degree of professionalism and discretionMulti-tasking capabilityGood computer skills with good working knowledge of a range of computer packagesAbility to lead and develop junior staffFlexible and adaptable to a developing work environmentProven clinical research experience