Director, Site Management & Monitoring

Director, Site Management & Monitoring (12 Months FTC)Location: Luton (on-site 3 days per week)

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the worlds most serious diseases. But were more than one of the worlds leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!

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 aligning 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.

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

Key Responsibilities:

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

Ensures adequate resources for the studies assigned.

Ensures 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.

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

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 (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

Ensures collaboration with local Medical Affairs team.

Ensures that study activities at country level align 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.

Requirements:

Bachelor degree in related field, preferably in life science, or equivalent qualification (*).

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

Excellent interpersonal skills.

Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and contribute to business.

Proven project management experience.

Excellent organisational, analytical, influencing and negotiation skills.

Excellent presentation and communication skills, verbal and written.

Desirables:

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 the requested standards.

Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

In Office Requirement:

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?

Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. It's our combination of curiosity and courage that drives us, inspired by the possibility of doing things that have never been done before. Empowered to step up, we free ourselves from fear of failure to dig deep into the biology of complex diseases and make bold decisions. Celebrating our successes and failures along the way.

Competitive salary and benefits package on offer.

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.