• Oversee the planning, implementation, and reporting of clinical trials with a focus on clinical operations deliverables.• Director and Associate Director levels manage Clinical Trial Managers, Clinical Research Associates, and other clinical team members by overseeing resource allocation, reviewing site and study team performance, providing feedback to CRAs and CTMs, resolving issue escalations from study team• Ensure clinical studies are properly resourced, managed, and executed within budget.• Participate in the design, development, and review of clinical trial protocols, amendments, informed consent forms, study guidance and manuals, case report forms, and any other clinical research study-related documents and study reports; may oversee projects from a clinical management perspective.• Motivate direct and indirect reports and deliver results for the clinical services branch. Build and maintain positive team-based culture.• Identify the need for new policies, processes, guidelines, and SOPs for Regulatory Affairs branch, and facilitate their creation• Evaluate Regulatory intelligence to assist in the development of local, regional, and global Regulatory strategies • In partnership with the Quality Affairs branch, provide Regulatory assistance before inspections and audits - as well as follow-up input after inspections and audits - to minimize potential for findings of noncompliance• In partnership with the Quality Management, keep abreast of industry developments – forthcoming regulations, guidance, best practices; provide expert and practical guidance and advise to company, regional management, and sponsors partners on the laws, regulations, and industry best practices that are applicable to the clinical trials.• Establish and lead the global Regulatory Affairs branch personnel, including manage escalations, mentor, train and evaluate performance of Regulatory professionals, if applicable

• Oversees the planning, implementation, and reporting of clinical trials with a focus on clinical operations deliverables.• Participate in the design, development, and review of clinical trial protocols, amendments, informed consent forms, study guidance and manuals, case report forms, and any other clinical research study-related documents and study reports.• Motivates direct and indirect reports and deliver results for the clinical services branch. Build and maintain positive team-based culture.• In collaboration with other group Directors, develops and maintains group capability (staff, facilities, equipment), develop guidelines/policies for process standardization and optimization to conduct a broad range of clinical trials. Participates in the creation and implementation of global SOPs, ensuring staff is trained. In conjunction with the SVP Project Operations and other branch heads, establishes policies and operational practices and assure exemplary ethical standards.• Develop innovative, advanced new concepts that improve processes across own and related disciplines, prioritizes and coordinates all efforts within the clinical operations group, and collaborates between other groups and branches, resolve issues, and accomplish organizational goals.• Collaborate with Process & Technology group for the implementation of emerging technologies and tools to enhance efficiency, productivity, and competitiveness of the clinical operations group.• Oversee quality control management of clinical operations services (including but not limited to quality oversight visits of Clinical Monitors) including quality review checks of Monitoring Reports.• Responsible for management and oversight of clinical operations team members (CTMs, CRAs, CTAs)• Lead and partake in regular team meetings/ teleconferences; participate/present at bid-defense/ client presentation meetings, as necessary; participate/present at conferences related to clinical operations.

Manage multitude of site activation, regulatory submission and clinical staff of varied skill levels ranging from entry level to management. Provide focused coaching, mentorship, and career development. Conduct regular performance appraisals. Interview, recruit, select, and train staff. Provide client operational oversight management for several large pharmaceutical companies for all studies conducted in North America. Act as a liaison between project team management and sponsor to optimize the successful operational delivery of project deliverables. Provide operational and project oversight of some of the earliest COVID 19 studies starting in February 2020. Activate approximately 150 research sites in USA and CANADA in 8 weeks with average site activation timeline of less than a week. 2020 CEO Defining Principles Award Winner for outstanding work on early COVID 19 studies. Provide financial oversight to studies within books of business. Review budgets for consistency and completeness. Address out of scope requests with project team and discussed impacts to study budget. Author of Formal CAPA (Corrective and Preventive Action) response to process deviation breaches. Submission of Non-Critical Quality Events to Quality Assurance Group. Author/reviewer of Electronic Medical Records (EMR) SOP. Content creator and presenter for the development of training programs, including but not limited to: Canadian Regulatory Document training, Heath Canada Submission Training, Regulatory Compliance Lunch and Learn Series, Communication Styles Training, multitude of Client SOP training sessions.Alliance Management of specialized site networks (Sarah Cannon Research Institute and US Oncology Research). Provide direct oversight to project teams on interactions and appropriate process within specialized networks. Author related guidance documents and coordinate applicable training sessions.Provide country level expertise as part of study bid process.

Lead site start up portion of global clinical trials. Directs the technical, operations and financial aspects of site start up deliverables on a global basis.Integrate with functional leads (project management, clinical management, regulatory and legal) to identify, evaluate, coordinate, and oversee fundamental issues pertaining to the successful site identification and activation of a clinical trial.Provide accurate projections, reports, updates, and ongoing risk assessment. Accountable for achieving projected site activation deliverables within the time period specified by the client within the contract.Oversee study level submissions to country regulatory agencies, ethics committees, institutional biosafety committees and other applicable review bodies. Work with country team to coordinate necessary responses.Support operational teams in feasibility research, site identification and selection.

Drive all aspects of study start up on global clinical trials. Includes, but not limited to the creation and negotiations of investigator budgets and investigator site contracts, coordination and completion of country regulatory and ethic committee submission, creation and negotiation of informed consent forms to client specifications.Author of study start up related project plans including the investigator package plan, statement of agreement and budget plan, regulatory and ethics submission plan.Create, monitor and update Project Schedule, allocate resources according to project scope.Review study spending against budget, implement cost containment strategies to prevent write offMaintained study trackers, clinical trial management system (CTMS) and electronic Trial Master File (eTMF).Presented weekly status updates to client

Manage and facilitate the regulatory affairs operations of all clinical studies within the SCRI Services division.Manage regulatory operations department staff. Provide direct oversight and direction for regulatory affairs associates. Hire and train all new regulatory staff. Develop career pathways and create job descriptions. Perform quarterly and annual staff competency evaluations for all direct reports.Facilitate cross functional collaboration with internal departments, such as project management, and external clients to develop compliant regulatory strategies.Author of various key departmental documents such as SOPs, best practice guidelines, templates, forms, etc.Collaboration with the medical writing department to update several company document templates (e.g., study protocol template, informed consent form template, etc.) to ensure the inclusion of 21 CFR, GCP, and ICH elements.Create training documents and lead training sessions on important regulatory affairs topics and procedures.

Used MS Word, Adobe Acrobat, Documentum, CoreDossier, XML Spy, ISI eCTD Express, ISI Toolbar, Global Submit Validate and Global Submit Review to bookmark, hyperlink, program XML backbone, validate and review submissions in eCTD format.Managed, compiled and published Investigational New Drug (IND) applications, New Drug Applications (NDA) and Biologic License Applications (BLA) in traditional paper, CTD and eCTD format.Developed pricing structure used by business development to create proposals for the submission of regulatory documents to FDA in traditional paper, CTD and eCTD format.Authored Standard Operating Procedures (SOPs) for the submission of regulatory documents to regulatory authorities in traditional paper, CTD and eCTD format.Created proposals and performed presentations for prospective clients regarding eCTD submissions to regulatory authorities.

Acted as an assistant lead to the lead data manager of a Phase 3 asthma study.Performed third-party vendor reconciliation of laboratory data. Performed critical variable audits at study closure

Worked in conjunction with the Query Management Center, Inveresk clinical research associates, and project managers to produce clean patient deliverables for clients before deadline. Performed medical coding of adverse events and concomitant medications. Used basic SQL to retrieve information from Oracle database.

Assisted in writing regulatory plans, and prepared regulatory packages for principal investigators at study start-up. Reviewed informed consent forms, institutional review board (IRB) submissions, Form FDA 1572s, curricula vitae, medical licenses, protocol signature pages, IRB rosters, IRB approval letters, and IRB-approved informed consent forms.

Lead data manager and medical coder on a Phase 2 urinary tract infection study.Generated, updated, and resolved queries in database and on CRF. Performed dictionary coding of adverse events and medications.