Senior Manager, Study Start Up
Join us at Alexion, AstraZeneca, Rare Disease as a Senior Manager in Study Start Up. In this role, you will deliver site start-up activities for assigned studies and will work closely with various teams to ensure that site activation deliverables are achieved in a timely and efficient manner. You will also interact with Health Authorities within your respective country/region and may be responsible for submission and approval processes across multiple countries.
Accountabilities:
Coordinate and administer start-up activities of clinical studies from site identification through site activation. You will obtain and maintain essential documentation in compliance with ICH-GCP, Alexion/AstraZeneca Procedural Documents. You will also assist in negotiations of budget and contract with site resolution of issues and contract execution. You will have extensive interactions with Health Authorities in assigned countries or regions to facilitate the submission and queries to ensure successful country approval.
Essential Skills/Experience:
- Minimum 6 years of Study Startup experience
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
- Bachelor’s degree in related field, preferably in life science, or equivalent qualification
- Excellent knowledge of relevant local regulations in each of the countries responsible (as applicable)
- Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.
- Basic understanding of the drug development process.
- Excellent attention to detail, written and verbal communication skills
- Excellent collaboration and interpersonal skills.
- Excellent negotiation skills.
- Veeva Clinical Vault Experience
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Experience at CRO or Sponsor
- 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.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- 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.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!
At AstraZeneca, we are driven by our mission to bring patients closer. We are built to serve patients, and everything we do is led by their lived experience. We know our patients by name, we meet their families and their careers. We are curious, co-creative, attentive, and close to each one, razor focused on their needs so we can tackle the toughest challenges for them. Joining us means embracing an opportunity where work isn’t ordinary, in a company where 'Here it means more' is more than a statement, it’s an ethos.
Ready to make a difference? Apply today!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.