Global Study Associate Director – Late Phase

Location: Barcelona, Spain (on-site) / 3 days working from the office and 2 days working from home

This is what you will do:  

The Global Study Associate Director (GSAD) is a business-critical role whose main accountability is the delivery of clinical studies. The GSAD is responsible to lead a cross-functional study team and provide the team with direction and guidance to enable successful study delivery. The GSAD is accountable to the GPT for the delivery of a study according to agreed upon timelines, budget, and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners. 

The GSAD leads the study team in accordance with the Rare Disease Study Team Operating Model for Internal Delivery (rSOLID) and/or clinical outsourcing model (e.g., SCOPE), current clinical trial regulations (e.g. ICH GCP), current observational and post-marketing study regulations (e.g., GVP), Standard Operating Procedures (SOPs), policies and best practices (e.g. job aides, guidelines), and in line with Alexion’s mission, values, and behaviours. 

Studies may be across various therapeutic areas and all phases (I-IV, including Late Phase, Non-Interventional, Post Authorization Safety Studies, Registries, Early Access Programs, etc.).  

You will be responsible for:  

• Lead and coordinate a cross-functional study team of experts in accordance with the internal operating model (rSOLID) and outsourced operating model (SCOPE) and its roles, accountabilities, and responsibilities framework (RACI) to ensure the clinical study progress as planned, driving achievement of milestones according to timelines, budget, and quality standards. 

• Develop and maintain relevant study documents/plans (e.g., global study management plan and its relevant components, etc.) including required input into clinical study protocol, clinical study report, and study level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans, inspection readiness plans, etc.). 

• Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed.  

• As the leader of the Clinical Trial Team (CTT), is the main point of contact for the Global Project Team (GPT)/Global Medical Affairs and relevant Project Subteams, eg the Clinical Sub-Team (CST).  

• Accountable for study performance against agreed upon plans, milestones, and key performance indicators (KPIs, quality and operational). 

• Maintain study tracking systems and project timelines (e.g., PLANIT,  CTMS, TMF dashboard, etc.) and communicate any risks to timelines and/or quality to relevant projects subteams, along with proposed mitigations. 

• Identify and report quality issues that have occurred within the study in accordance with relevant SOPs and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g., CPT, quality assurance staff, functional line management, etc.). 

• Oversee TMF completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times. 

• Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, Clinical Trial Transparency, etc.). 

• Ensure studies are inspection-ready at all times, according to ICH-GCP, GVP, SOPs, and relevant policies/guidelines.  Primary Clinical Operations point-of- contact in the event of an audit or inspection. 

• Ensure that the risk response strategies and issue escalation pathways are clear to the entire study team. 

• For outsourced studies, be the primary Alexion point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget, and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g., description of services, transfer of obligations, etc.). 

• Ensure all external service providers (e.g., central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented. 

• Accountable for planning, tracking and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals. Develops and maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals, and identifying any financial risks and mitigation plans (as a part of the ongoing study change control process). 

• Delegate and oversee team member responsibilities. 

• Conducts lessons learned exercises to provide continuous process improvement and sharing of best practices.  

• Work on non-drug project work such as Clinical Operations representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager. 

• Works with global and country teams to determine appropriate country footprint for the study, including consolidation of information from country teams to support internal governance approvals for the study. 

• Leads and coordinates Key External Expert (KEE) outreach activities to assess study design suitability and/or identify opportunities for protocol improvement. 

• Partners closely with Strategic Feasibility to develop country and site footprint proposals and patient enrolment projections for endorsement by Global Program Team (GPT)/Global Medical Affairs. 

• Maintains global oversight of study deliverables, milestones, and site monitoring throughout the study lifecycle. 

• Works with global and country-level stakeholders to mitigate risks or issues related to site management and monitoring as they arise. 

• Support other study and functional activities, as assigned. 

You will need to have: 

• >7 years of clinical research experience, 2 of which in a leading role accountable for the planning and execution of global clinical trials. 

• Bachelor’s degree or equivalent, in one of the disciplines related to clinical practice/health care, life sciences, or drug development, or commensurate work experience. 

• Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development. 

• Solid knowledge in observational and real-world evidence study management processes and post-marketing study regulatory requirements  

• Strong, demonstrated abilities/skills in team leadership. 

• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills. 

• Excellent communication and interpersonal skills. 

• Strong strategic and critical thinking abilities. 

• Strong organizational and problem-solving skills. 

• Ability to manage competing priorities. 

• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. 

We would prefer for you to have: 

• Advanced degree (Masters, Ph.D.) is desirable.  

• PMP certification desirable.