AstraZeneca is looking for a Global Study Manager for its global hub in Barcelona for a temporary contract.
Typical Accountabilities:
* Contribute the development of study documents as appropriate as well as any pdates/amendments, ensuring template and version compliance.
* Manage the set-up of third-party vendors, assessing initial statement of work and budget, as well as the change order process.
* 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.
* Assist in 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.
* Support risk management and quality efforts to ensure study compliance.
* Prepare presentation material for meetings, newsletters and websites.
Requirements:
* 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 3 years clinical trial experience, of which at least 2 years are in 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
Offered:
- Temporary contract of at less than nine months
- Immediate incorporation
- Attractive compensation package
- Smartworking policy
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