Our Client AstraZeneca is looking for a Clinical Project Manager for its global hub in Barcelona for a temporary contract.
Your FunctionsProvides 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.
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.
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.
Prepare presentation material for meetings, newsletters, and websites.
Direct the study team in the implementation of audits and regulatory inspections.
Position RequisitesFormación: Licenciado: BiologíaIdiomas: Inglés: C1Conocimientos: Ensayos clínicosExperiencia: 2 añosUniversity 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 a minimum of 5 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-oriented.
Ability to lead, coordinate, and prioritize 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.
Your Benefits- Temporary contract of less than nine months.
- Immediate incorporation.
- Attractive compensation package.
- Smartworking policy.
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