We currently have an exciting new opportunity for an Associate Project Manager to join our growing team, sponsor dedicated. The Associate PM is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management. This is a permanent role with ICON and fully home-based. You must be located in the following countries to be considered: Hungary, Poland, Czech Republic, Spain.
Responsibilities:
Leads/contributes to the preparation of delegated study documents (e.g., Informed Consent Form, master Clinical Study Agreement, etc.), and external service provider related documents (specifications, study specific procedures, descriptions, presentations, etc.).
Maintains and facilitates interactions with internal functions and external functions including the CROs and other external service providers to ensure efficient study delivery to time, costs, and quality objectives.
Contributes to the planning and conduct of internal and external meetings (e.g., Investigators'/Monitors' meetings).
Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
Ensures that all study documents in scope of global associate project manager responsibilities are complete and verified for quality in the Trial Master File.
Supports Global Study Directors and/or GSAD with budget management, such as external service provider invoice reconciliation.
Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and international guidelines such as ICH/GCP to ensure the study is inspection ready at all times.
For outsourced studies, supports Global Study Directors and/or GSAD in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget, and quality standards.
Qualifications:
University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
Vendor management experience.
Knowledge of clinical development/drug development process in various phases of development and therapy areas.
Excellent knowledge of international guidelines ICH/GCP.
Excellent communication and relationship building skills, including external service provider management skills.
Good project management skills.
Demonstrated ability to collaborate as well as work independently.
Demonstrated leadership skills.
Computer proficiency, advanced.
You MUST be located in the following countries to be considered: Poland, Czech Republic, Spain, Hungary, Bulgaria. You MUST come from a Clinical Research background and have experience in roles such as Global Clinical Trial Administrator, Project Specialist supporting the global clinical study team, CRA, or In-House CRA.
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