Study Start up Manager
At AstraZeneca, we unlock the power of what science can do. Empowered to explore, everyday we work towards our ultimate aim – treating, preventing, modifying and even curing complex diseases.
With an unwavering belief in following the science, we unleash our curiosity. Investing in key areas, harnessing innovative technologies and taking smart risks. Help to shape the future of healthcare as we take our pipeline from strength to strength.
Embrace an environment built on lifelong learning. Never complacent, we seek opportunities to expand our knowledge. The place to build a long-term meaningful career.
Here we get to develop and grow – whether that’s working at the leading-edge or on varied stages and molecules. Working on things that have never been done before.
In return, when great science comes alive, we have the opportunity to get published.
We stand together behind a shared ambition. United by our collective passion for having a positive impact on patients’ lives. Important work that is both meaningful and fulfilling. With the potential to reach over a billion patients across the globe who are living with these complex diseases.
Background & Qualifications
- University degree, preferably from Healthcare related areas (Pharmacy, Chemistry, Biology, Medical etc. Faculties),
- Good level of English,
- Minimum 1 years’ experience in clinical trial start up phase including prepare, review, track and manage site regulatory documentation
- Strong communication and negotiation skills,
- Ability to prioritize and handle multiple tasks,
- Basic coaching skills and good at team work,
- Effective planning and organizational skills with result-oriented approach,
- Stakeholder management experience,
- Analytical thinking, critical reasoning ability,
- Good command of MS Office applications,
- No restriction to travel,
- Driving License,
- No military obligation for male candidates.
- Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process;
- Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.
- Actively participates in Local Study Team (LST) meetings.
- Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
- Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
- Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Support QC checks performed by LSAD or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs
- Serve as the primary point of contact for the Start-up and Contract Specialist during start-up on allocated projects.
- Serve as a subject matter expert for all issues relating to contracts and grants department processes and corporate/procurement/AstraZeneca policies and procedures for contracts and grants functions.
- Assume primary responsibility for tracking, maintenance and accuracy of metrics, contract documents, and supporting documentation.
- Reviews essential document packages for site activation and also be involved in essential document collection from sites.
- Prepares and submits Central EC Applications, RA Applications as required. Prepares ongoing submissions, amendments, and periodic notifications required by central EC and RA, and other local regulatory authorities as needed within the country.
- Establish master agreements, lean process enhancements and other innovative solutions to expedite site initiation.
- Review, authorize and/or manage payments where appropriate. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
A high performing team, we work hard to not just meet but go beyond the needs of patients and the wider healthcare industry We leverage our partnerships with external experts across the industry, to create and communicate evidence that changes medical practice. As a partner for many, we effectively communicate complex ideas whilst seeking to understand ever-changing needs and requirements. Our valuable contribution and scientific expertise is responsible for advancing our pipeline and accelerating our pathway to finding a cure.
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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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.