Clinical Development Manager

Description: Lead and manage a cross clinical delivery sub team to operationally deliver defined clinical studies /GMD or clinical project activities to time, cost and appropriate quality. Global Career Level-E Accountabilities/Responsibilities: Lead and manage a cross clinical delivery sub team to operationally deliver defined clinical studies /GMD or clinical project activities to time, cost and appropriate quality. Lead the operational delivery of clinical studies, via a team of contributing experts from the study specification to the final clinical study report and archived master file. Provide input into study feasibility and study specifications, and produce essential documents including the authoring of clinical study protocols across both interventional and non interventional studies. When working across studies or project work package ensures consistency across the development program. The CDM may be asked to take up a direct leadership role for a large project work package (such as project managing delivery of a national payer evidence dossier). To be the interface to partners and oversee the delivery to plan of studies performed through external partners (such as Alliance partners, CROs, vendors and Academic Research Organizations) and to monitor progress, identify and solve operational issues. Responsible for ensuring compliance by clinical delivery sub team with mandatory governance controls such as (Delegation of Authority, Sarbanes Oxley Act, Study attestations, Letter of Assurance and Clinical Trial Disclosure). Lead the development, baselining and maintenance of realistic, up to date and appropriate quality, project and study plans (including timings and total costs) in agreed systems (such as IMPACT, OPAL and ACCORD). Lead/contribute to clinical submission assembly, regulatory response and payer evidence teams and contributes to advisory board and steering committee meetings. Management of changes to project scope and costs (including CRO and other vendors change orders) and reporting project status by participating in project planning and control activities and generation of status reports as required. Accountable for agreeing with the project team and functions the most efficient procedures to support delivery by taking the project situation and compliance requirements into account. This includes ensuring sufficient appropriate training on AZ processes, SOPs, standards and templates is provided to external partners. Where appropriate, to apply lean sigma and change management techniques to work packages and in continuous improvement projects. Minimum experience–Education and Experience University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred. At least 5 years experience from within the pharmaceutical industry or similar organization or academic experience. Extensive knowledge of clinical operations, project management tools and processes Good experience of clinical development / drug development process in various phases of development and therapy areas. Project management certification is desirable but not mandatory. Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable but not mandatory. Evidence of developing partnering skills Ability to learn Exhibit AZ Leadership Capabilities at level 2 Drives Accountability, Works Collaboratively, and Strategic Leadership, Exhibits AZ core Capabilities, Influencing, Financial/Fiscal Awareness and Supplier/Partnership Management Date Posted 19-6月-2017 Closing Date AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.