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Site Management and Monitoring (SMM) Oncology Lead – Germany (m/f/x)

Location Hamburg, Hamburg, Germany Job ID R-148952 Date posted 26/09/2022

The Site Management and Monitoring (SMM) Oncology Lead (m/f/x) 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 Site Management and Monitoring (SMM) Oncology Lead – Germany (m/f/x), 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.

Typical Accountabilities:

  • 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.

Qualifications

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.

  • 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.

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.

10000930 G CDSM

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