• Accountable for overall management of multiple clinical trials • Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols • Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion • Leads the Clinical Study Team (CST) and may participate in other cross functional program team meetings • Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs • Responsible for preparing and/or presenting to executive management as delegated • Develops, reviews and/or consults on clinical trial documents, such as study specific plans, informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates • May be responsible for participating and presenting at Investigator Meetings, SIVs and other program meetings • Responsible for study level clinical operations budget forecasting, accrual management and quarterly review ensuring tight control between study forecasts and actuals • In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc • Review and approve contracts, work orders and invoices prior to submission to senior management for approval • Lead the creation/definition of the scope of work and selection process for assigned program’s vendors and Contract Research Organizations (CROs) • Demonstrates consistent and regular Sponsor Oversight and performance management for all utilized vendors and/or CRO third party contracted vendors • Attend CRO or other vendor meetings, such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals • Draft and/or manage Governance charters/meetings/reports with CRO • Co-lead Sponsor/CRO operational meetings with CRO to ensure deliverables are on track • Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close out, completion of Trial Master File and the following: • Responsible for setting up, negotiating, and monitoring Task Order invoice payments for CRO (direct service and pass through costs), as well as to oversee scope change negotiations • Responsible for negotiating site Clinical Trial Agreements in conjunction with the Legal Department and CRO • Responsible for patient recruitment and retention plans • Responsible for the set-up of all third-party vendor specifications (i.e. IWRS, eCRF, central laboratory/ECG, etc.) and on-time third party deliverables • In conjunction with CRO/Regulatory, participate in the collection, preparation, and review of regulatory documentation for IRB/Ethics submission prior to study start-up • In conjunction with Clinical Supply, responsible for assuring sufficient clinical drug supply (including comparator) is forecasted, packaged, available and imported/shipped to depots/sites for study start up, and that sufficient supplies are maintained during the study • Responsible for assuring accurate drug accountability/reconciliation for investigational product (IP) issued during the study to the site and at the end of the study • In conjunction with CRO, responsible for assuring sufficient ancillary supplies are available and shipped for the study (i.e., templates, binders, forms, supplies, etc.) • Accountable for eTMF – completeness, timeliness, and quality on assigned programs. Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files • Partner with Quality organization to document Sponsor Oversight of all vendors, Data Integrity, and Risk Assessment requirements • Participates and responds to Quality Assurance and/or regulatory authority inspection audits • Ensures all assigned studies are always Inspection Ready • Accountable for working closely with Biometrics, Pharmacovigilance, Medical, and the CRO to participate in data review, and oversee adherence to study timelines and data quality. Oversight includes the following activities: expedited query resolution, support creation of logic edit checks, data line listing review, QA/QC of adverse events, and serious adverse event processing. Oversight of protocol deviations/variations • In conjunction with the CRO, oversee and drive the metrics on CRA source data verification.