Clinical Study Manager
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Clinical Study Manager, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. North American Commercial is the 'face' of AstraZeneca and MedImmune to our many healthcare clients. They represent many of the most well recognized and respected products in the industry, and build strong relationships with healthcare professionals.
As a Medical Affairs Clinical Study Manager , you work on behalf of US Medical Affairs, accountable for the delivery of US clinical studies according to agreed timelines, budget, and resources. You will ensure compliance with relevant AZ/External Service Provider(s) SOPs, processes, and ICH/GCP guidelines and provides oversight of External Service Provider(s) outsourced deliverables.
As a Medical Affairs Clinical Study Manager your main responsibilities will involve:
•Ensure External Service Provider(s) manage their portfolio of deliverables according to agreed timelines, budget and quality
•Forecast day to day management of study timelines, budget, materials and development of detailed study level plans in collaboration with External Service Provider(s)
•Track and manage to agreed study timelines, budget and ensure update of appropriate systems (eg, IMPACT) in collaboration with External Service Provider(s)
•Monitor the progress of clinical activity and produces regular and ad hoc reports and presentations to US Medical Affairs management as required
•Oversee and manage budget for assigned studies and negotiates budgets and contracts with External Service Providers(s) and investigative sites
•Oversee management of External Service Provider(s) activities and other External Partners to ensure quality is consistent with company requirements
•Manage contract compliance, vendor/bid selection, cost/benefit tracking for External Service Provider(s)
•Responsible for establishing and maintaining External Service Provider(s) relationships, providing performance management as necessary
•Plan and lead activities associated with audits in liaison with CQA; contribute to regulatory inspection strategy teams as required
•Participate in negotiations and selection process of External Service Provider(s)
•Ensure operational and strategic input from other AZ functional areas (eg. Regulatory, Patient Safety, etc.)
•Ensure appropriate training is achieved at Investigator Meeting
•Work with other members of organization and External Service Provider(s) to share knowledge, experiences and best practices
•Lead and/or provide input into non project work, training activities and development of procedures as needed
•Act as support for External Service Provider(s) for GCP and relevant AZ processes as necessary
•Provide operational feasibility expertise and delivery of approved protocol in line with US Medical Affairs agreed strategy
•Liaise with External Service Provider(s) to identify and resolve operational issues, and facilitate start up activities
•Develop and manage contingency risks plans in collaboration with External Service Provider(s) to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate
•Provide operational study delivery expertise input into the clinical content of study design concepts and clinical study protocols
•Responsible for ensuring timely compliance by with companywide governance controls (eg, Continuous Assurance, Clinical Trial Disclosure, Corporate Integrity Agreement, etc.) in collaboration with External Service Provider(s)
•If applicable, ensure appropriate training is delivered to External Service Provider(s) on AZ processes, standards, templates and SOPs
•Provide performance feedback to External Service Provider(s) to enhance delivery of studies
•Responsible for measurement and reporting of key performance indicators that efficiently and effectively monitor key aspects of study performance
•Communicate and coordinate regularly with National Co-ordinating Investigator/ National Lead Investigator on recruitment and other study matters
Your Skills and Capabilities:
•Demonstrate operational expertise in risk management and contingency planning
•Apply industry best practice to the design and execution of clinical studies to improve time and cost efficiency
•Act as a role model in line with AZ core values and behaviors
•Demonstrate an extensive knowledge of clinical study and drug development process, GCP/ICH guidelines and SOPs
•Demonstrate conceptual, analytical and strategic thinking
•Effective problem and conflict resolution skills and proven team focus
•Demonstrate good team skills including cooperation, concern for impact, willingness to learn from others, and sharing of relevant information
•Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills
•Proven leadership experience and strong collaborative communications with External Service Provider(s)
•Project management experience (specifically leading) within the context of clinical development (including scope, budget, timeline)
•Excellent verbal and written communication skills
•Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
•Create, develop and implement more effective and efficient methods/processes of delivering clinical trials with reduced budget, less time at the same or improved level of overall quality
•High level of interactive communication to set clear direction for the External Service Provider(s) within the studies
•Proven ability to drive performance and delivery through internal and external partners
•Ability to effectively manage multiple deliverables simultaneously
As a Medical Affairs Clinical Study Manager it's essential that you have:
•University degree, preferred in biological science or healthcare-related field
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Requirements:
Minimum of 5 years experience in Clinical Operations or other related fields (Medical affairs led studies or Academic led studies)
•Excellent knowledge of spoken and written English
•Extensive knowledge of clinical and pharmaceutical drug development process at various phases of development
•Proven project management delivery and demonstrated ability to manage multiple deliverables
Next Steps – Apply Today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
