Director, Site Management & Monitoring
Location: Luton (onsite 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 world’s most serious diseases. But we’re more than one of the world’s 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.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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.

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.

AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next:

Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you!

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.

Date Posted

20-Sept-2024

Closing Date

01-Oct-2024

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.