When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!
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. You will lead a cross-functional study team and provide them with direction and guidance to enable successful study delivery. You are also accountable to the Global Project Team (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, 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 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 rSOLID 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), be the main point of contact for GPT and 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 CPT, 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, SOPs, and relevant policies/guidelines. Be the 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 supervise team member responsibilities.
Conduct 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.
Work 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.
Lead and coordinate Key External Expert (KEE) outreach activities to assess study design suitability and/or identify opportunities for protocol improvement.
Partner closely with Strategic Feasibility to develop country and site footprint proposals and patient enrolment projections for endorsement by Global Program Team (GPT).
Maintain global oversight of study deliverables, milestones, and site monitoring throughout the study lifecycle.
Work 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.
Strong team leadership skills.
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.)
PMP certification
At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.
Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.
#J-18808-Ljbffr
