AstraZeneca Senior Global Study Manager (Early Development)

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Here in the ICON FSP team, we've entered into a partnership to supply a full-time, permanent home-based UK-based Senior Global Clinical Study Manager to manage the team of Global Study Managers. You will be working with a top-10 multinational pharmaceutical and biopharmaceutical company. This is a new role for the partnership, though you will be joining an existing team of dynamic and experienced ICON staff, working on a portfolio of engaging clinical studies.

The successful applicant should have >2 years’ experience in Commercial Global Study Management, and will be looking forward to providing support (in a coaching and mentoring capacity) to the GSM working on the clinical study to ensure the same goal is achieved. Whilst your focus will be overseeing operational activities and delivery, your responsibilities may also include hands-on Global Study Management.

 The Senior Global Study Manager is responsible for leading the operational activities to support and enable the delivery of clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the exact nature of the clinical program, so a high degree of flexibility is required.

Typical Accountabilities:

• Provides operational expertise to the study team.

• Lead the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.

• Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.

• Create team culture and promotes team spirit within the GSMs and GSAs assigned to the study team.

• Provide mentoring and guidance to the operations team ensuring effective collaboration and communication with the study team.

• Manage the set-up of third-party vendors, assessing initial statement of work and budget, as well as the change order process.

• Provide input to data management documents (e.g. Case Report Form, Data Validation Specification), and interface with data management representatives and sites to facilitate the delivery of study data.

• Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.

• Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.

• Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.

• Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.

• Oversee the clinical trial insurance process; track approvals, revisions and renewals of certificates.

• Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.

• Drive risk management and quality efforts to ensure study compliance.

• Manage set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.

• Prepare presentation material for meetings, newsletters and websites.

• Direct the study team in the implementation of audits and regulatory inspections.

• Identify areas of best practice / process improvements and knowledge share across the group.

• Contribute to review of new/amended/unique SOPs and guidance documents.

• University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience

• Deep understanding of the drug development process with minimum of 5 years clinical trial experience, of which at least 2 years are in commercial global study management

• Experience of working with and delivering through strategic partners and 3rd party vendors

• Excellent knowledge of ICH-GCP principles

• Team orientated

• Ability to lead, coordinate and prioritise multiple tasks and deliverables

• Proactive approach

• High degree of flexibility

• Demonstrated verbal and written communication skills

• Good negotiation and collaboration skills

• Demonstrated interpersonal and problem-solving skills

• Ability to manage change and actively seek and champion more efficient and effective ways of working

• Ability to coach & act as a buddy for more junior colleagues

• Some travel may be required

Desirable

• Early phase oncology clinical trial experience

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.