Responsibilities will include, but are not limited to, the following:
1. Study Team Leadership - Lead cross-functional study team, develop, manage and maintain study timelines, minutes, budget and tracking, develop training materials and train team on study procedures, develop study management plan - study specific working practices, develop, manage, and maintain relationships with affiliate offices, develop study execution plans, provide mentoring and training
2. Study Planning - Review and comment on synopsis and protocol and CRFs, develop overall study budgets, approve number of investigative sites, train study team in protocol, develop investigational product supply forecasting / management, input on project specifications and feedback on requirements for CTMS, guide structure and oversee set up TMF
3. Selection and Evaluation of Investigative Sites - Participate in country selection, in collaboration with physician and CRS identify prospective investigative sites, review feasibility, participate in final investigative sites selection, develop and monitor investigative site budgets and negotiate financial terms of individual site budgets, manage site payments, monitor GCP/ICH site level compliance
4. Identification and Selection of Vendors - Participate in preparation of RFP, assumptions and SOW, recommend vendors, contribute and review specs for vendors (IVRS, Labs), manage study vendors, review and approve vendor invoices
5. Preparation of Study Documentation - Review essential regulatory documents, prepare detailed study timeline, develop and oversee risk management plan (e.g. for poor enrollment), prepare, review and approve Monitoring Plan, assure adherence to Monitoring Plan, review CRF design (paper), review eCRF specs (EDC) and review of CRF completion guidelines, design, review and approve study tools (for investigative site use), create study team contact roles and responsibilities, review DM documents (CRO and in-house studies), facilitate Development and Review of Data Review Plan
6. Input Clinical Database, Safety and CSR Reports - Review edit specifications (paper and EDC), participate in creation of user management tool (UMT), execute EDC User Acceptance Testing (UAT) scripts, review Summary Reports, CSR review – appendices and approval, oversight of IND safety report distribution to investigators and study team
7. Initiation and Site Start Up - Prepare and review material for investigator meeting and CRA Training, conduct CRA training, plan / organize / conduct Investigator meeting, oversight of country regulatory approvals (e.g. CTA, MoH), obtain country / site IRB / ethics committee approval, address issues from IRB discussion, prepare / review regulatory package (essential documents - blank forms and templates for 1572s, financial disclosure, etc.), prepare study binder for investigator meeting, obtain appropriate country/site insurance, authorize investigational product shipment to investigational sites, including (in association with Regulatory) the initial shipment, review and approve site-specific informed consent forms
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