In this role at a local CRO I led a team consisting of internal employees and external consultants in implementing a project designed to overhaul and redesign processes, systems to ensure compliance with all applicable standards and regulations. It also entails reviewing the organizational structure to ensure compliance, the correct fit for further business growth, and to embed a culture that will attract and retain the best talent. The specific activities within this project included: business process and decision making process mapping in the “as is” state using BPMN and DMNmethodologies; reengineering and streamlining business processes; designing the organization’sresponsibility assignment matrix (RACI matrix); implementing a KPI-based goal setting and performance evaluation system from scratch; implementing organization-wide monitoring using Balanced Scorecard methodology; redesigning of job profiles, job descriptions, SOPs; implementation of internal compliance procedures and systems; overhaul of interview and hiring process; preparation for ISO 9001 and GDP recertification audits.

In this role I contributed to the leadership and management of the affiliate by ensuring it adheres to the highest scientific and ethical standards and fulfils all regulatory requirements, provided strategic direction and leadership to the local Medical Department, contributed to the collective Medical leadership of the Company and to the appropriate use of company products, represented Roche medical authority with key external stakeholders. I was accountable for: medical strategy and tactics for the affiliate; evidence generating activities (including phase II-IV clinical trials and Real World Data projects); scientific collaboration and medical information; medical compliance and training; drug safety/pharmacovigilance. As people leader, I was responsible for developing and managing a highly motivated and effective team with a performance-led culture, striving for excellence and strong focus on cross-functional collaboration (last team size was 31 approved FTEs, with 2 vacancies).

Job responsibilities substantially similar to most recent role.

In this role I contributed to the leadership and management of the affiliate by ensuring it adhered to the highest scientific and ethical standards and fulfilled all regulatory requirements, provided strategic direction and leadership to the local Medical Department (team of 17 at its highest), contributed to the collective Medical leadership of the company and to the appropriate use of company products, represented Roche medical authority with key external stakeholders. I was accountable for: medical strategy for the affiliate; all non-promotional activities, including budget accountability; data generating activities; knowledge-sharing, including medical information, medical education, congress activities and publications; research & educational grants; strategic partnerships, including KOL interactions; pharmacovigilance; compliance to company and regulatory guidelines, healthcare compliance; ethics/integrity; media communication on medical issues; clinical operations; regulatory affairs.

Job responsibilities included set-up of clinical trials (interventional and non-interventional) operations from scratch for F. Hoffmann-La Roche affiliate in Ukraine. This included identification of business and medical needs in cooperation with Medical Director and business units, project selection and feasibility assessment, preparation and defending of study budgets, selection of sites and vendors including laboratories and CROs, coordinating the drafting, legal review and negotiation of the contracts with sites and vendors, interaction with regulatory authorities and ethics committees in the course of obtaining the necessary approvals, managing the clinical trials projects in all operational aspects ensuring budget and timeline forecasts are met, supervising and mentoring monitors. I also acted as Compliance and Training Officer/Quality Assurance Responsible for Medical Department. During the absence of Local Safety Specialist I took on responsibilities as his back-up. From October 2012 I took on responsibilities as Acting Medical Director in coordinating the work of Roche Ukraine Medical Department (including Regulatory Affairs & GMP Certification, Healthcare Compliance, Safety, and Clinical Trials).

Job responsibilities included managing investigator sites, including selection, training and monitoring; conducting site feasibilities, and taking part in investigator selection; arrangement study logistics at country level and for investigational sites; preparation of local submission files for regulatory authorities and ethics committees; collection and preparation of TMF documents; maintenance of clinical trial databases; participation in negotiation of site budgets with investigators and other external study personnel; mentoring newly-hired monitors and providing on-the-job training via co-monitoring visits. The job required medical education at graduate level, fluent English, IT skills, punctuality, ability to manage multiple tasks simultaneously. Due to prior supply chain experience, I provided support to colleagues on supply chain/customs issues. I also served as a local subject matter expert on the remote data capture system.

Job responsibilities included coordination of day-to-day activities of a company (staff of 25) providing professional services in clinical research. This included strategic negotiation with the sponsors, management of everyday relationship with the sponsors, participation in budgeting and resource allocation, overseeing training activities of the staff and providing the training personally, mentoring newly-hired staff, review and internal approval of timesheets and expense reports, internal performance review, regulatory compliance and quality assurance activities, drafting of SOPs for the company and management of SOPs lifecycle. During company director's absences I took on the role of acting director.