AstraZeneca 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.

The GSM supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The GSM works cross-functionally with internal and external partners to lead & deliver aspects of the clinical study in accordance with Senior Global Study Leader (SrGSL) or Global Study Leader (GSL) delegation, applicable clinical trial regulations (ex. ICH-GCP), Standard Operating Procedures (SOPs), policies & best practices and values & behaviours.

Typical Accountabilities

• Perform study management tasks as per agreed delegation/oversight by SrGSL/GSL.
• In partnership with internal experts and external service providers, provide oversight (as delegated by the SrGSL/GSL) to ensure study delivery of both internally-run and outsourced studies.
• Lead/contribute to the preparation of delegated study documents (e.g. Informed Consent Form, applicable study plans, etc.), and external service provider-related documents (e.g. specifications, study specific procedures, etc.)
• Maintain and facilitate interactions with both internal & external functions to ensure efficient study delivery to time, costs and quality objectives.
• Manage the set-up and maintenance of third-party vendors.
• Support the SrGSL/GSL with budget management. Initiate contract/budget requests for third-party vendors, facilitate generation of purchase orders, track spend against approved budget and manage the change order process.
• Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.
• Contribute to the planning and conduct of internal and external meetings.
• Ensure adequate supply of study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
• Proactively contribute to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
• Ensure that all study documents within scope of the GSM’s responsibilities are complete and verified for quality in the Trial Master File (TMF).
• Adhere to SOPs, global process, applicable Quality & Compliance manual documents and international guidelines (e.g. ICH-GCP) to ensure study is inspection ready at all times.
• Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their line manager. May act as Subject Matter Expert for a particular process or system within Study Management Early.

Essential

• University degree (or equivalent educational/work experience), preferably in medical or biological sciences or discipline associated with clinical research.
• At least 12 months relevant pharmaceutical industry and/or clinical trial experience, in a clinical project management role.
• Early Oncology experience (though transferrable early development experience from other TAs may be accepted for the right candidate)
• Experienced working as part of the global study team
• Solid knowledge of the nuances of Phase 1 & 2 and the speed of execution required
• Vendor management experience
• Strong soft skills: collaboration / partnering cross functionally; teamwork; influencing
• Experience of working in big pharma environment a plus
• Deep understanding of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development.
• Proven organizational, time management & analytical skills; excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment
• Demonstrated ability to work well both on a cross-functional team and independently
• Ability to prioritize appropriately and to be adaptable
• Demonstrated leadership skills

Desirable

• Experience in external service provider management
• Experience in all phases of a clinical study lifecycle
• Demonstrated project management skills

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.