Clinical Research Study Leader - Oncology
You will provide leadership for global study management teams (SMT) that are accountable for strategic and tactical activities, ensuring high quality execution standards are met within agreed budgets and timelines. Responsible for the planning, coordination, communication, motivation and direction of the SMT, you will identify key milestones and track critical study activities, issues and strategic priorities. You will also conduct protocol and site feasibility assessments, tasking accountability for all aspects of study management. Through proactive management you will contribute to CRO selection and contract set-up, ensuring communication channels remains open for the entire study lifecycle. You’ll work with Pharma Development Quality Assurance as appropriate and ensure adverse events are documented, processed and reported according to current SOPs. You will review study data listings for accuracy prior to inclusion in regulatory documentation and clinical study reports. Who you are You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.We are looking for a highly motivated and committed individual with strong leadership competencies, so you should be a strategic thinker with exceptional communication skills at all levels. You will have the ability to work effectively both within a team environment and independently and you should be able to demonstrate the capability to negotiate and influence stakeholders for a successful output. You will hold a degree, or equivalent, in a biomedical or life sciences discipline with considerable study management experience in clinical or pharmaceutical development. You will be required to have extensive experience leading Phase I and Phase II oncology studies, experience you’ll have likely gained leading numerous clinical studies in pharma and/or biotech. Prior management or mentoring responsibility is preferred. You will be well versed in planning, risk mitigation, trial budgets, site selection, clinical supplies management, sample management, conduct and the monitoring of clinical studies. Your sound understanding of scientific rationale and protocol design, combined with your effective leadership skills will compliment your critical reasoning and ability to identify (and then resolve) complex problems. Prior global experience would be beneficial. In return we offer a competitive salary plus the excellent benefits you would expect from a bluechip organisation, including a genuine interest in your development. Who we are Our UK Pharmaceutical head office is situated in Welwyn garden City, Hertfordshire, with beautiful country side surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. With over 1400 people occupying our site in Welwyn, you can expect opportunities in Early Development (pRED), Product Development (PD), Commercial (Rx) and of course our corporate function.Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.