Study Start-Up Manager
Join us as a Study Start-Up Manager in our Oncology R&D department, where you will play a pivotal role in gaining approval for our novel work on unmet medical needs. You will be responsible for managing and conducting start-up activities at the country level, ensuring compliance with AZ procedures, local and international guidelines such as ICH - GCP, and relevant regulations. Your role will involve preparing, reviewing, tracking, and managing site regulatory documentation at the country and site level, maintaining, reviewing, and reporting on site performance metrics.
Accountabilities:
As a Study Start-Up Manager, you will contribute to ensuring that clinical and operational feasibility assessment of potential studies is performed to the highest quality. You will be accountable for study start-up and regulatory maintenance, being in charge of the collection, preparation, review, and tracking of documents for the application process. You will also be responsible for the submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during the start-up period.
Essential Skills/Experience:
- Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDP.
- Basic understanding of drug development process.
- Good collaboration and interpersonal skills.
- Good verbal and written communication skills.
- Excellent attention to details.
- Excellent understanding of Clinical Study Management and study start-up.
- Good negotiation skills.
- Good ability to learn and to adapt to work with IT systems.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Integrity and high ethical standards.
- Good analytical and problem-solving skills.
- Good financial management skills.
- Basic change management skills.
- Good intercultural awareness.
Desirable Skills/Experience:
- Experience in Oncology R&D.
At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe. As part of our Oncology R&D team, you will work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We are an inclusive, diverse, and bold team that thrives on smart risks and innovative problem-solving. We are all compassionate team players and driven achievers who are always ready to step up. We see change as an opportunity, embracing the possibility to learn, grow, and evolve. We believe that by asking questions and trying new things, we can drive innovation and develop modern approaches.
Are you ready to play your part in gaining approval for our novel work on unmet medical needs? Apply now to join our team!
e annual base pay for this position ranges from $101,948.00 - $152,922.00. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted
04-Oct-2024Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.