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  • 1 month ago

jobs description

Your role
• 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 CDPC 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

As a member of the Clinical Trial Team:
• Represent the CSL group at the Clinical Operations Team (COT)/Clinical Trial Team (CTT) via:
• Regular review meetings of study/site performance and quality metrics and the associated strategic action planning
• Ad hoc interactions to address immediate issues
• Other COT/CTT meetings as appropriate e.g. kick-off meeting
• 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 objectives:
• * Lead identification and implementation of optimal solutions, considering program and study characteristics, with clearly delineated key performance indicators to deliver tangible impact and drive study execution e.g. utilising digital channels, biomarker-driven recruitment services and Decentralised Clinical Trial (DCT) capabilities such as telemedicine, mobile health applications, wearable sensors, direct to patient medication, etc.
• Oversee service providers to ensure successful implementation within agreed timelines, budget, and quality
• 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
• * Develop, implement and follow up on robust Site Oversight Plans, in collaboration with the CTL(s) and working closely with the respective CSLs
• * Identify and encourage use of data-driven oversight tools and methods at the site and study level
• Identify trends and issues within/across assigned study(ies) which may impact key study deliverables (e.g. timelines/quality/costs) and work with CSLs, CTLs, Data Managers, Clinical Lead(s) and other relevant business partners to implement action plans to resolve and/or mitigate
• Participate in Investigator/Study Coordinator Meetings and promote information sharing with the CSLs as needed

Who you are
• 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

Job specific Compentencies and Skills
• 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

This position can be filled in Europe or the US.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team
Greater London UK


Apply - Associate Director, Trial Clinical Delivery Lead 1 Greater London