At AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

The Study Start-Up Team Manager is responsible for overseeing the implementation of the start-up component of the clinical interventional and non-interventional studies as well as maintenance activities on projects according to established resources and schedules in accordance with the AZ procedures, documents, local and international guidelines and relevant regulations.

SSU Team Manager will also oversee the collection of core, site documents, the adaptation and approval of the ICF, submissions to the EC, updating in the systems and other activities relevant for start-up period.

The SSU Team Manager as part of the Site Management & Monitoring team (SM&M) will function operationally as a member of a Project Team, ensuring the start-up and maintenance deliverables and timelines are achieved.

The Study submission lead will plan and pro-actively coordinate, together with the study Local Study Managers (LSMs), the study start-up and transition to the Ongoing phase of the studies. Additionally, will oversee submission activities for studies already activated, to ensure key milestones are achieved within budget, on schedule and in compliance with the appropriate - quality standards.

The SSU Team Manager can be a point of contact for early landscaping of new indications and feasibilities conducted by SM&M Poland. Oversight of local feasibility process through to country selection including ensuring robust processes are in place for conducting feasibilities through early insight into Biopharma & Oncology studies planned to come to PL and/or studies that are a good fit for PL.

The SSU Team Manager will ensure continuous SSU process improvement and establish high quality standards across all AZ internally managed studies. Optimising and standardising AZ way of working in PL environment, establishing innovative approaches, managing stakeholders & building the reputation of AstraZeneca to be the sponsor of choice in the PL.

Typical accountabilities:

• Ensuring adequate resource planning for new work across TAs allocated to PL SMM to enable timely allocation of staff to support Local Study Teams during start-up and later on when studies are being activated.
• Contribute to PL SMM organisation and its functioning at country level as a member of the PLSMM Management Team
• Ensuring performance development of the SSU team
• Ensuring ongoing mentoring and development of SSU team and supporting more junior LSMs during start-up/ active phase of the study.
• Assist LSMs in forecasting study timelines.
• Supports SMM region in initiatives/activities as appropriate
• Ensure that study activities undertaken by the SSU team at country level comply with local policies, regulations & code of ethics
• Project oversight of all studies through to site activation for purposes of SSU team resourcing.
• Provide direction to LSM/SSU team members on ways of working during start up and active phase including resolving SSU process issues as identified.
• A point of escalation to support resolution for any complex issues with study start up, including ethics, regulatory, contract, budgets etc.
• Local process owner for study start up – ensuring maintenance of guidelines, templates etc and process improvement
• Ensure excellent understanding of the PL clinical trial environment, working externally to influence and improve the PL clinical trial environment (URPL, ECs etc).

Requirements:

• University degree in biological science or healthcare-related field, or equivalent.
• Minimum 3 years’ experience in Clinical Operations (CRA / Sr. CRA / LSM) or other related fields.
• Minimum 2 years’ Study start-up experience in PL environment
• Proven team building and people/organizational development skills.
• Strong desire for proven project management experience.
• Excellent knowledge of spoken and written English.
• Good ability to learn and to adapt to work with IT systems.
• Excellent knowledge of relevant local regulations.
• Ability to deliver quality according to the requested standards.
• Excellent interpersonal skills.
• Excellent organisational, analytical, influencing, negotiation skills.

Desirable:

• Line manager/ Team Lead experience
• Excellent knowledge of the Clinical Study Process, AZ Procedural Documents and international ICH/GCP guidelines.
• Excellent medical knowledge in relevant AZ Therapeutic Areas.
• Excellent knowledge of the Drug Development Process.
• Good understanding of the Study Drug Handling Process.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and reduced cycle times.
• Ability to work in an environment with remote collaborators.
• Ability to manage change with a positive approach for self, team and business and able to see change as an opportunity to improve performance and add value to business.
• Integrity and high ethical standards.
• Excellent resource management skills.
• Excellent decision-making skills.
• Excellent presentation and communication skills, verbal and written.
• Excellent ability to have attention to details and combining with delegation and prioritisation skills.
• Excellent ability in working according to global standards.
• Good financial management skills.

Next step - Apply today!

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 only employs individuals with the right to work in the country/ies where the role is advertised.

Date Posted

Closing Date

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.