AD - Clinical Trial Delivery Lead

We have a new and exciting opportunity for a Senior Global Clinical Project Manager to join a FSP program sponsor dedicated to a Global Pharma.  This is a permanent role through ICON and home-based. 

You must already be working within a Pharma or CRO setting with at least 10 years of Global Project Management expertise.

Countries considered: France, Germany, Italy, Spain, Poland, UK, Bulgaria

• Accountable for the delivery and quality of site level activities in Phase I-IIIb Clinical Development studies; act as link between CSLs, Global functions & CRO counterparts - single point of contact for site management & operational topics/escalations; support information channelling and issue resolution for the study
• Provide leadership, strategic direction and operational oversight for Clinical Site Lead (CSL) activities across assigned study(ies) in response to quality and performance oversight measures and trends
• Serve as the operational delivery expert for the study(ies) and promote data-driven, realistic planning at the site and study level. Drive delivery-focussed accountability and ownership amongst key external (CRO/vendor partners) and internal partners as appropriate
• Facilitate identification and implementation of operational excellence strategies within studies - leveraging expertise within Global Development Operations (GDO) and other partner functions
• Ensure timely and appropriate escalation of trends, issues and risks within the Clinical Operations Team/Clinical Trial Team/CRO/Vendor Team, department Leadership Team and/or Senior Management as appropriate
• Promote solution-orientated thinking and issue resolution at the country and study team level. Provide an escalation pathway to ensure study-specific major observations from CSLs are relayed to and followed up by the appropriate internal and/or external business partners
• Support product and study-specific onboarding for new team members and contribute to enhancing their site/study management capabilities/skills
• Promote product knowledge, collaboration and information channelling; contribute to best practice guidance to drive consistency in the management of sites/studies
• Lead regular calls with CSLs working on study and/or other activities within the assigned study(ies)
• Act as functional lead for process improvement initiatives
• Consolidate data-driven, CSL assessment of country and site selection proposals, ensuring quality and consistency across regions and countries to support CTT decision making; inform CSLs of resulting choices of regions/countries/sites
• Lead activities with internal and external stakeholders to proactively gather and integrate patient and physician insights into study design and conduct e.g. utilising Patient and Site advisory boards, social media campaigns, surveys, interactions with patient advocacy groups/organisations etc
• Design country start-up strategy in consultation with the Start-up Solutions Team and Country Start-up Specialists (CSS), and in alignment with the CTL(s) and CRO(s). Work closely with the CSL to oversee and ensure delivery at the site and country level
• Design patient and site centric recruitment and retention strategies, in consultation with the CTL and CRO/Vendor(s), and in alignment with the study and company diversity and inclusion
• Establish monitoring strategy, including management of identified risks, in collaboration with the CTL(s) and CRO(s) and incorporating principles of a risk-based quality management approach. Ensure monitoring strategy is updated in response to changes of external environment and/or availability of internal data
• Utilise site performance and quality data analytics to drive proactive, risk-based site oversight practices and quality risk oversight and management across all stages of study delivery

• Requires graduate background (Medical or Life Sciences degree) in a clinical research related discipline or equivalent
• Clinical operations experience – ideally across Phases (I-IIIb)
• Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g., ICH GCP and applicable regional/local regulations)
• Oncology and/or Neurology and/or Immunology TA experience desired
• Substantial (10+ years) professional and project management experience in clinical research in a CRO, pharma or biotech company including site management/oversight, clinical study planning and conduct
• Adaptability / Flexibility, Critical Thinking, Strong Communication Skills, Analytical Skills, Business Partnering, Clinical Trials Knowledge, Influencing Skills, Strategic Thinking, Therapeutic Area Knowledge
• Ability to work independently on assigned tasks or projects
• Aptitude to interpret outputs from analytical tools to enhance and improve study execution
• Ability to assess risk, solve problems and take decisions
• Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way 
• Demonstrated good interpersonal skills
• Good cultural awareness
• Comfortable working in a fast‐paced environment where speed is paramount
• Fluency in English (oral and written) plus local language
• Position may require domestic/international travel up to 20% of time