Director Site Management & Monitoring Oncology Milano

Director Site Management & Monitoring Oncology
Milano
Lombardia, Milano

Director Site Management and Monitoring Oncology

At AstraZeneca every one of our employees makes a difference to patient lives everyday.

Each and every one of us believes that science has the ability to change lives and that to deliver this takes many people with many skill sets.

When we deliver a life-changing medicine, that success comes from the combined efforts of all of our people.

Welcome to **MIND (Milan), ** one of over 400 sites here at AstraZeneca.

The site provides a collaborative environment where everyone feels comfortable and able to be themselves, which is at the core of AstraZeneca's priorities.

The **Director Site Management & Monitoring (DSMM)** is accountable for delivering the committed part of all clinical interventional studies under their supervision according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH- GCP as well as relevant local regulations.

The DSMM is responsible for line managing dedicated group(s) of staff and responsible for planning and utilization of staff resources, assigned budget, objective setting and performance follow-up.

It is also expected that the DSMM may contribute to regional/global work tasks as delegated.

As assigned, the DSMM is accountable for ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

In some countries a DSMM may also take responsibilities as Local Study Associate Director (LSAD) or Clinical Quality Associate Director (CQAD) if required and agreed with the (Senior) Director, Country Head.

**MAIN DUTIES AND RESPONSIBILITIES

- Leadership of dedicated group, building the team spirit, developing team style and behaviour.

- Ensures adequate resources for the studies assigned and that the workload of direct reports is adequate.

- Development and performance management of direct reports; ensures that direct reports have development and training plans, according to IDP process.

- Coaches the direct reports on a regular basis, and plans/organises coaching with external providers if needed.

- Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible (Senior) Director, Country Head and local HRBP.

- Contributes to efficient SMM organisation and its functioning at country level by working closely with responsible (Senior) Director, Country Head.

- Contributes to high quality feasibility work,

- Actively contribute to global SMM indication network

- Oversees successful delivery of SMM study delivery country level targets to plan, with speed and quality.

- Understand barriers to enrollment and contribute to mitigations.

Engage with global stakeholders with solutions to optimise enrollment

- Co-Shape strategies to maximise Italian enrollment

- Contributes to the quality improvement of the study processes and other procedures.

- Ensures completeness and timeliness of the eTMF to maintain it "Inspection Ready".

- Assists (Senior) Director, Country Head or Local Study ADs/ Local Study Teams in forecasting study timelines, resources, recruitment, study materials and drugs.

- Provides direction to LSAD/ Local Study Teams on major study commitments including resolving any key issues identified.

- Supports SMM region in initiatives/activities as agreed with (Senior) Director, Country Head.

- Ensures collaboration with local Medical Affairs team.

- Ensures that study activities at country level comply with local policies and code of ethics.

- Reviews SQV reports of direct reports in line with AZ SOPs

- Reviews Accompanied site visits/co

- monitoring visits/training visits/QC visits performed to direct reports in line with the local QC plans.

- Performs accompanied site visits according to local QC Plan, supporting ongoing coaching and development.

**ESSENTIAL REQUIREMENTS

- Bachelor degree in related discipline, preferably in life science, or equivalent qualification

- Minimum 5 years of experience in Development Operations (CRA / SrCRA / LSAD) or other related fields.

- Clinical Oncology knowledge and process

- 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.

- Identifies and triages issues; bringing scenarios to resolve

**DESIRABLE REQUIREMENTS

- Line management experience.

- Very good knowledge of the Clinical Study Process 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 deliver quality according to