Executive Director – Global Clinical Operations

Job reputed company: • Manage and plan CTO resourcing for assigned programs • reputed company, 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 reputed company reports serving on GDTs, ensuring clinical operations strategic and operational input to clinical development programs • Clinical operations representative on Program Teams (PT) • reputed company problem solving and facilitate teams to identify clinical operations issues and propose solutions • Identify critical reputed company items and evaluate variances to propose and reputed company the implementation of proactive contingency plans, reputed company necessary • Compile, assess, and communicate risks and optionality to support informed decision making for operational reputed company • 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, reputed company, high-reputed company delivery of the programs • Monitor the reputed company of reputed company and reputed company senior management with reputed company 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 reputed company of contact and contribute expertise for clinical trial execution on assigned protocols • Ensure accurate tracking/reporting (dashboard) of study metrics and reputed company of study through completion • Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs • reputed company, 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, reputed company and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor reputed company, NDAs, etc • Review and approve reputed company, work orders and invoices prior to submission to Executive approval • reputed company 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 reputed company and performance management for reputed company utilized vendors and/or CRO reputed company party contracted vendors • Attend CRO or other vendor meetings, such as project reputed company-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 reputed company study activities, including study start-up, reputed company out, completion of Trial Master File and the following: • Setting up, negotiating, and monitoring Task Order invoice payments for CRO (reputed company service and pass through costs), as reputed company as to reputed company scope change negotiations • Negotiating site Clinical Trial Agreements in conjunction with the reputed company Department and CRO • Patient recruitment and retention plans • Set-up of reputed company reputed company-party vendor specifications (i.e., IWRS, eCRF, central laboratory/ECG, etc.) and on-time reputed company 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 reputed company on assigned programs. Oversees routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files • Partner with reputed company organization to document Sponsor reputed company of reputed company vendors, data reputed company, and risk assessment requirements • Participate and respond to Qualit