• Manage and plan CTO resourcing for assigned programs • Lead, build and mentor CTO team supporting assigned program(s) • Serve as a member on Clinical Operations Leadership Team (COLT) • Create and support implementation of Clinical Operations processes, platforms and/or systems • Clinical operations representative on global development teams (GDT) and/or oversees direct reports serving on GDTs, ensuring clinical operations strategic and operational input to clinical development programs • Clinical operations representative on Program Teams (PT) • Lead problem solving and facilitate teams to identify clinical operations issues and propose solutions • Identify critical path items and evaluate variances to propose and oversee the implementation of proactive contingency plans, when necessary • Compile, assess, and communicate risks and optionality to support informed decision making for operational strategy • Strong collaboration and partnership with cross functional colleagues globally (e.g., Clinical Development, Project Management, PVE, Regulatory, Biometrics, Clinical Pharmacology, CSM, Medical Affairs, etc.) to ensure on-budget, timely, high-quality delivery of the programs • Monitor the progress of projects and provide senior management with timely updates, changes in scope and resource requirements across the assigned clinical program(s) • Work cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Serve as the central point of contact and contribute expertise for clinical trial execution on assigned protocols • Ensure accurate tracking/reporting (dashboard) of study metrics and progress of study through completion • Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs • Develop, review and/or consult on clinical trial documents, such as informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates • May be responsible for participating/presenting at Investigator Meetings, SIVs and other meetings • Accountable for program 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 Executive approval • Lead the creation/definition of the scope of work and selection process for assigned program’s vendors and Contract Research Organizations (CROs) in partnership with Clinical Business Operations • Demonstrate 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 • 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: • 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 • Negotiating site Clinical Trial Agreements in conjunction with the Legal Department and CRO • Patient recruitment and retention plans • 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 • Collaborate with Clinical Supply to assure 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 • In conjunction with CRO, accountable 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, accountable 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. Oversees 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 • Participate and respond to Quality Assurance and/or regulatory authority inspection audits • Ensure all assigned protocols are always inspection ready • Accountable for working closely with Biometrics, Pharmacovigilance and the CRO to oversee data cleaning and review, and oversee adherence to study timelines and data quality. • In conjunction with the CRO, oversee and drive the metrics on CRA source data verification