Site Management and Monitoring (SMM) Oncology Lead - Germany
We are seeking a strong leader excited to implement the Oncology clinical trials in-country. The growing AZ Oncology portfolio delivers global clinical trials projects recruiting many thousands of patients every year in countries across the world.
As the SMM Oncology Lead role you will be accountable for delivering all the Oncology clinical interventional studies under your supervision according to agreed resources, budget and timelines complying with AstraZeneca Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations.
You will accountable for the performance of the Oncology sites selected; ensure that Oncology study sites are identified, qualified and monitored according to AZ SOPs.
You will be also responsible for line managing of dedicated group of staff and managing the local leadership team, as well as planning and utilization of staff resources, assigned budget, objective setting and performance follow-up.
Do you have experience in Oncology Clinical Operations and strong leadership capabilities? Would you like to apply your expertise to impact the delivery of our clinical trial programs in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
This role sits within our Late Oncology Clinical Operations team, which is part of our broader Oncology Research & Development organization. Oncology Clinical Operations (Late Stage) is responsible for the program and study management of clinical projects designed to generate clinical evidence in support of a registrational strategy. Therapeutic expertise in oncology, project management capability and effective leadership of cross functional teams are critical capabilities that exist within the group to ensure strategic plans are translated into action.
What the role involves
The Site Management and Monitoring (SMM) Oncology Lead is accountable for delivering the oncology clinical interventional studies in their country. In this role, you will lead and manage the resources assigned to the clinical trials. You will oversee the budgets and timelines and support implementation using local relevant local regulations and international ICH-GCP guidelines.
As the SMM Oncology Lead, you will be part of the Oncology SMM Leadership Team and line manage a dedicated group(s) of staff. In addition, you will ensure clear communication to the Oncology SMM Global Head of any risk to study performance, feasibility assessment, enrolment and mitigation of risk to delivery of the programs. This role requires close partnership with the Country Head Site Management and Monitoring (CHSMM) who holds statutory country level responsibilities (e.g. legal, regulatory responsibilities) and ensures a "one SMM community". It is also expected that in this capacity, you may contribute to local/regional/global work tasks as delegated.
- Leadership of dedicated oncology group, building the team spirit, developing team style and behaviour.
- Ensures adequate resources for the oncology studies assigned to the country.
- Ensures that the workload of the team(s) is adequate.
- Development and performance management
- Ensures that everyone in the team has development and training plans, according to IDP process.
- Coaches the team members and all direct reports regularly, and plans/organises coaching with external providers if needed.
- Prepares salary and bonus proposals for all team members based on their performance in collaboration with the Oncology SMM Global Head and local HRBP.
- Contributes to efficient SMM organisation and its functioning at country level by working closely with CHSMM.
- Contributes to high-quality feasibility work and delivery of established country enrolment projections.
- Oversees successful delivery of oncology SMM study delivery country level targets to plan, with speed and quality (includes supporting the local implementation and optimisation of AstraZeneca's digital strategy)
- Delivers country-level oncology budget to plan with agreed RBU targets
- Contributes to the quality improvement of the study processes and other procedures.
- Ensures all systems are continuously updated.
- Ensures completeness and timeliness of the eTMF to maintain it "Inspection Ready".
- Assists Local Study Managers/teams in study feasibility, forecasting study timelines, resources, recruitment, study materials and drugs.
- Provides direction to LSM/teams on major study commitments including resolving any key issues identified.
- Supports SMM initiatives/activities as agreed with Oncology SMM Global Head.
- Ensures collaboration with local Medical Affairs team.
- Ensures that oncology study activities at country level comply with local policies and code of ethics.
Essential for the role
- Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (*).
- Minimum 7 years of experience in Development Operations (CRA / Sr. CRA / LSM/ADSMM) or other related fields.
- Strong technical and extensive oncology clinical operations experience.
- Previous line management experience.
- Proven team building and people/organizational development skills.
- Excellent interpersonal skills.
- Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
- Proven project management experience.
- Excellent organisational, analytical, influencing and negotiation skills.
- Excellent presentation and communication skills, verbal and written.
- Excellent decision-making skills.
- Excellent team building skills also in cross-functional teams.
- Excellent resource management skills.
- Good financial management skills.
- Excellent ability to have attention to details and combining with delegation and prioritisation skills.
- Excellent knowledge of spoken and written English.
- Good ability to learn and to adapt to work with IT systems.
- Ability for national and international travel.
Desirable for the role
- Very good knowledge of the Clinical Study Process, Procedural Documents and international ICH-GCP guidelines.
- Excellent knowledge of the Monitoring Process
- Excellent German and English skills
- Good understanding of the Study Drug Handling Process and the Data Management Process
- Good knowledge of relevant local and international regulations.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Ability to work in an environment of remote collaborators.
- Integrity and high ethical standards.
- Good conflict management skills and ability to handle crisis.
- Good interviewing skills - responsibility for attracting, developing and retaining personnel.
- Good intercultural awareness.
- Excellent ability to work according to global standards.
So, what's next?
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