Associate Director Clinical Research, SMM US
Do you have expertise in, and passion for, Clinical Research? Would you like to apply your expertise to impact the lives of patients in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca ,we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
We are looking for an Associate Director for Clinical Research. This position is a direct functional line management of a group of Clinical Research Associates within US Site Management and Monitoring. You'll be accountable for the successful execution of clinical trials including resource allocation, adherence to timelines and compliance with all SOPs, policies and regulatory requirements. This position oversees project assignments, workload distribution and problem resolution with direct reports. You will also Interact with other team management and functions as needed.
Additional Responsibilities May Include:
- Responsible for performance management and development including talent development, coaching, mentoring and providing routine feedback.
- Interviews, hires, develops and trains staff on AZ SOPs, policies and procedures.
- Communicates regularly with contract staff managers to provide feedback on contract staff performance.
- Evaluates and projects resource needs on an on-going basis based on portfolio.
- Ensures the implementation of clinical studies through efficient allocation of CRAs.
- Ensures close working relationship within US SMM including other CRA managers and Clinical Research Managers as well as other key internal/external stakeholders.
- Responsible for ensuring adequate, timely and compliant monitoring, site management and oversight for assigned CRAs.
- Conduct regular (twice annually) quality visits with each employee CRA.
- Communicate with staff on program changes, policy changes, and priority shifts on a regular basis.
- Be aware of issues affecting staff's workload and efficiency. Collaborate with colleagues and US leadership team as needed for escalation and support for resolution.
- Review and approve expenses; assure expense reports are being submitted on a timely basis and are in compliance with the company's policies.
- Conduct regular staff meetings and participate in Management staff meetings.
- Leads special initiatives as needed.
Education, Qualification, Experience, and Skills-Required:
- Partner with key operational sites to develop/enhance AZ relationship.
- Participate in training and mentoring of new members of the local Study Delivery Team ensuring compliance with ICH/GCP and AZ Procedural documents.
- Contribute to process improvements, knowledge transfer and best practice sharing.
- University degree in related discipline, preferably in life science, or equivalent qualification.
- 8 years of clinical trial experience with at least 4 years of site monitoring. Study leadership and/or line management preferred.
- Fluent knowledge of spoken and written English.
- Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations.
- Good medical knowledge in relevant AZ Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Ability to travel required, approximately 15%.
- Ability to deliver quality according to the requested standards.
- Ability to work in an environment of remote collaborators.
- Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.
- Good analytical and problem-solving skills.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Good cultural awareness.
- Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey. Are you already imagining yourself joining our team? Good, because we can't wait to hear from you!Where can I find out more?
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