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RWE Medical Lead is the key Medical Affairs role that focuses on the responsibilities to ensure either leadership and execution of a combination of managed primary data collection non-interventional studies, Investigator Initiated Studies (IIS), and managed secondary data use Real World Evidence activities (RWE), and/or the country management of global studies ensuring the effective and efficient delivery of all operational aspects in accordance with the appropriate quality standards including ICH/GCP and GVPs/GPPs.
Evidence generation studies transform the data into meaningful insights, creating outputs that may be used for publication, regulatory submissions, internal decision-making, market tracking, or other uses.
This role plays a strategic importance in collaboration with the local/global Clinical Operation Cluster, Disease Area Medical Enablers, Disease Area Teams, Healthcare Professionals (HCPs) & Organizations (HCOs), Clinical Operations team, external vendors and other functions in order to achieve the outcomes of the evidence generation studies/projects and medical affairs programs; and is encouraged to use new and emerging data sources and technologies to drive innovation and to conduct analyses at scale.
This role reports directly to the Medical Excellence Lead.
Key Responsibilities
You ensure study adherence to appropriate guidelines (ICH GCP/GVP/GPP), relevant regulations and Roche procedural documents and ensure the completion and finalization of any corrective and preventive action plans resulting from site audits and inspections.
You provide operational input and insights into the development of study protocols, Clinical Study Reports, informed consent form and protocol feasibility questionnaires.
You promote operational excellence and oversee the delivery and maintenance of essential study plans and systems (e.g. site & country selection and monitoring plan; study tracking systems, clinical supply; vendor oversight plan; RBQM or equivalent risk management activities).
You chair Study Management Team meetings and organize the investigator meetings and study kick-off meetings.
You establish and maintain study budgets and approves invoices, identify and communicate any issues/variances with study budgets and action plans for resolution
You are accountable for all vendor related operational study deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. You lead vendor selections by reviewing proposals and providing recommendations, review and negotiate clinical work orders.
You ensure proper handling of all study close out activities including but not limited to the site close out, final drug accountability, final safety reconciliation and Inspection readiness of Trial Master File documentation.
Who You Are
You have a Bachelor's degree in a discipline related to health or science.
You have previous experience with Clinical Trials and/or Real World Evidence Studies/Medical Affairs Programs in the pharmaceutical and/or CRO industry, preferably previous experience as a Project Manager or Study Lead.
You have fluency in Turkish and English.
You have strong leadership skills developed through leading successful multi-functional matrix study teams through all stages of clinical studies.
Proven strategic capabilities, organizational awareness, and proactive planning with embedded contingencies and a risk management mindset.
You have clear understanding and experience applying ICH/GCP and/or GVP/GPPs and applicable regulations including awareness of quality requirements.
You are able to work closely with other countries/communities/teams, embrace the loop of ‘sharing and learning together’ to co-create Solutions.
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.