Global Study Associate Director, Early 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 EPT/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 Early Phase clinical outsourcing model (EPA), current clinical trial regulations (e.g. ICH GCP), Standard Operating Procedures (SOPs), policies and best practices (e.g. job aides, guidelines), and in line with Alexion’s mission, values, and behaviours. Studies are focused on Early Phase Healthy Volunteers and Patients and may be placed across various therapeutic areas.
You will be responsible for:
Lead and coordinate a cross-functional study team of experts in accordance with the EPA outsourcing model 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 or oversee development/maintenance of 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., riskbased 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) the GSAD is the main point of contact for the external vendor (CRO), Global/Early PT (GPT/EPT) and the clinical sub-team (CST).
Accountable for study performance against agreed upon plans, milestones, and key performance indicators (KPIs, quality and operational).
o Maintain study tracking systems and project timelines (e.g., PLANIT, CTMS, TMF dashboard, etc.) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations.
o 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.).
o 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.
o Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, Clinical Trial Transparency, etc.).
o Ensure studies are inspection-ready at all times, according to ICH-GCP, SOPs, and relevant policies/guidelines. Primary Clinical Operations point[1]of-contact in the event of an audit or inspection.
o 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 contracted under the EPA outsourcing model (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. Oversees development of study(s) budget by the external vendor. 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.
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.
Stong, 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.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.