Senior Study Start Up Manager
At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.
As a SeniorStudy Start Up Manger you will have local responsibility for conducting and facilitating specific start-up activities in order to obtain all necessary RA/ECs/Financial authorizations/approvals pertaining to phase I, II, III interventional clinical studies conducted in Italy, in compliance with AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations and according to study timelines
If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.
You are an experience professional with a passion for clinical trials implementation, above all sites contract development and negotiation. You are organized, but flexible and adaptable to unexpected changes. You can easily envision the bigger picture, without losing sight of the day-to-day tasks.
MAIN DUTIES AND RESPONSABILITIES
Reporting to the Director, Site Management & Monitoring, as Senior Study Start Up Manager you will act as the main point of contact with global Regulatory for Clinical Trial Application related topics in order to finalize documents for submission to local RA according to local low.
Additionally, in close collaboration with Local Study Team and Sites/Institutions, as Study Start Up Manager you will contribute to site identification and feasibility, collection and preparation of all necessary documentation that must be submitted to ECs according to EC/Institution procedures. This may include, but is not limited to, essential document collection and review, ICFs and local language label finalization, negotiation of Financial Agreement with Institutions.
As Senior Study Start Up Manager you will maintain oversight as far as concerns the RA and EC processes and you will be responsible of the management of the Clinical Trial Applications for the entire duration of the study.
The role broadly includes the following key components:
- manage all activities and account relationship according with Company Values, Code of Conduct, AZ Procedural Documents, Italian legislation and relevant Site / Institution Procedural Documents
- in cooperation with the Local Study Team, contributes to sites identification, feasibility and selection
- in cooperation with the Local Study Associate Director, contributes to define the local submission strategy to RA and ECs
- the main point of contact for the global Regulatory and Local Study Team for new CTA/SA/Notification/ general communication with local RA and ECs
- review all documents dispatched by the global Regulatory for local RA submission
- prepare all applicable documentation for submission to local RA and ECs (i.e. local language Cover Letter, local ICFs and other patients document, Insurance certificate, local language label for locally supplied drug)
- negotiate Financial Agreement (legal text and budget) with Institutions
- customize answers to RA objections and ECs requests
- perform QC on documents submitted and received by RA/ECs
- responsible for the completion and maintenance of the National Database of Clinical Trials (Osservatorio Nazionale sulla Sperimentazione Clinica dei medicinali – OsSC)
- maintains data tracking for RA and EC study oversight
- keeps Local Study Team informed on approvals timelines and regarding any potential/actual issue related to site activation. Contributes to issue resolution.
- maintains tracking of documentation submitted to/approved by RA and ECs
- maintains documents in electronic TMF
- contribute to the improvement of the study start up processes and other related procedures
- Scientific Degree equivalent degree
- Preferred 3-5 years experience in Clinical Trial Start Up and Contracting in a pharma company or CRO
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas
- Basic understanding of the drug development process
- Excellent attention to details
- Good written and verbal communication skills
- Good collaboration and interpersonal skills
- Good negotiation and problem solving skills
- University degree in biological science or healthcare-related field, or equivalent
- Good knowledge of spoken and written English
- Good ability to learn and to adapt to work with IT systems
- Good knowledge of GCP and relevant local low
- Good time management and organisation skills, ability to prioritize and multitask;
- Good oral and written communication skills
- Goal oriented attitude
- Diplomatic and interpersonal skills
- Good ability to have attention to details
- Ability to work independently as well as in team working
- Demonstrated project management skills including scope, budget, timeline, resource management and use of associated tools.
- Experience from Clinical Research/Operations (i.e. hands on work with Clinical Trial Management in the pharmaceutical industry)
- Knowledge of R&D ways of working
- Ability to effectively work with External Service Providers
- Ability to look for and champion more efficient and effective methods/processes
- ability to work in an environment of remote collaborators
- ability in working according to global standards
- good decision-making skills
You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
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 Line 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.
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 authorisation and employment eligibility verification requirements.