Associate Asset Lead
Site Name: Canada - Ontario - Mississauga, USA - Maryland - Rockville Posted Date: May 26 2021 Would you like to be part of GSK's emerging clinical leadership, with an opportunity to accelerate quality efforts across clinical operations on national and global scale? If so, this could be an excellent opportunity to explore. The Associate Asset Lead (aAL) is the responsible role for the execution and delivery of the Clinical and Epidemiology Plans of low complex programs or sub-programs and therefore is a contributor to the program strategy development and program delivery oversight. The aAL is the point of reference for operational planning, feasibility and delivery of their assigned studies and /or (sub)programs and associated Clinical and Epidemiological Plan(s) from beginning to end. He/she will support the development of project and/or study plans and coordinate expert input from clinical and non-clinical functions. The aAL is able to manage large & multidisciplinary team (up to 30 team members) and manages (sub)program and studies with a budget that can be >10 M€ with more than 15000 human subjects for studies. He/She takes operational decisions at (sub)program and/or study level (will refer to Project Delivery Lead and or Head Project Delivery Leads as needed). The aAL builds and provides robust estimates of timelines and costs, including resources. He / she will manage execution of the approved development plans to time, budget and quality. The aAL will work in collaboration with the PDL/DPT/VDT/VCT to ensure the delivery and oversight of the studies from the Clinical and Epidemiology within the approved timelines, budget and quality. The aAL is ensuring the translation of scientific objectives in the (sub)Program and/or Study Management Plan. By using integrated processes, tools and measures the aAL ensures the program and study oversight, delivery of the (sub)program and/or study on time, according budget and with quality, using a risk-based approach methodology. The aAL, in partnership with the Clinical and Epi Project Lead (CEPL) (for a (sub)program) and with the Clinical Research Development Lead (CRDL) (for a clinical study), Epidemiologist (for an epi study), Country Medical Directors (for local studies), co-ordinates all members of the (sub)program/study network to ensure the appropriate experts (both central and local, operational and medical/scientific) are involved at appropriate stages and outputs are delivered on time. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors in General Science or Life/Health related Science Degree At least 10 years of significant experience in managing complex clinical research studies and matrix teams, clinical operations or equivalent. Has a very good understanding of the clinical research and clinical trial management, associated regulatory, processes and quality requirements. Preferred Qualifications: If you have the following characteristics, it would be a plus: Master, Post graduate degree in a life science field desirable. Strong skills and experience in project management and tools. In depth knowledge of GCPs and ICH guidelines. Excellent communication and presentation skills. Solid experience working in teams with a broad range of cultures, including team leadership. Manages change with a positive approach and flexibility to the challenges of change for the individual, team and the business. Sees change as an opportunity to improve performance and add value to the business Applies industry best practices to Development plans to improve time and cost efficiency, including resource utilization Excellent risk mitigation, problem solving and conflict resolution skills Acts as a role model in line with GSK Vaccines core values and behaviors Proven experience in effective matrix management in global and remote environment for mid-size multidisciplinary teams. 2 years of experience in regional clinical study leadership desirable (field experience). People Management experience is desirable. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness #LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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