Excellent new opportunity at ICON on a global FSP program sponsor dedicated to a big global pharmaceutical. 

We are looking for an Global Study Manager/Associate Project Manager to join a growing and successful team working within Cardiovascular studies. This is a permanent and home-based role. 

Countries we can only consider: Poland, Bulgaria, Spain, Romania, Hungary and Portugal. 

You must be able to start by end of August. 

This role will suit someone who is working within a CRO or Pharma company, MUST have at least 3 years of Clinical Research experience working with studies. Ideal background would be Vendor Manager, Global Project Management Associate/Associate Project Manager. Must have strong vendor management experience, delivering studies across multiple countries and cross functional teams. This could also suit a SCRA/Lead CRA who has some local vendor experience with some regional/multi country experience. 

• In partnership with the team, other clinical experts and external service providers, the Global Study Manager provides oversight to ensure study delivery.
• 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 including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives
• Contributes to the planning and conduct of internal and external meetings (e.g. Investigators’/Monitors’ meeting)
• 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 GSM’s responsibilities are complete and verified for quality in Trial Master File
• Supports Global Study Director and/or Global Study Associate Director 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 study is inspection ready at all times
• Supports Global Study Director and/or Global Study Associate Director in project management as per agreed delegation

• University degree (or equivalent)
  Advanced degree 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.
• Knowledge of clinical development / drug development process in various phases of development and therapy area
• 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 computer skills in day-to-day tasks

CRA and CTM backgrounds are not considered. MUST come from a clinical research background and currently working in a Pharma or CRO

Job profiles that would be considered:

• Global Senior Project Specialist with Project Management tasks
• Vendor Manager within a pharma/CRO setting driving the global delivery of study management activities
• Associate Project Manager within CRO or Pharma setting driving global delivery of study management activities. 
• SCRA/Lead CRA who has some local vendor experience with some regional/multi country experience.