Global Study Associate Director - Single Sponsor dedicated

IQVIA LLC; Madrid; Presencial; EUR 110.000 - 150.000; Jornada completa

Descripción de la vacante

IQVIA Madrid seeks a Global Study Associate Director (GSAD) to lead cross-functional study teams across the study management lifecycle from handover through close-out. You will partner with CPT, manage timelines, budgets, and quality, ensuring inspection readiness and governance adherence.

You will mentor team members, drive risk management, oversee TMF completeness, and coordinate with CROs and external partners to deliver studies to high standards in a complex regulatory environment.

Formación

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
• 5 years of relevant clinical experience in the pharmaceutical industry, including 2 years’ project management experience, or equivalent combination of education, training and experience
• Extensive knowledge of ICH-GCP, clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development
• Demonstrated solid project management skills and knowledge of relevant tools
• 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

Responsabilidades

• Lead cross-functional study team or oversee outsourced delivery activities to ensure milestones are met on time, budget, and quality
• Lead and facilitate communication across all functions, including external partners and service providers
• Provide input into essential study documents (CSP to CSR) in line with SOPs
• Ensure external service providers (CROs, labs, IXRS, ePRO) perform to contracted goals and timelines
• Develop and maintain study plans including quality and risk management planning
• Accountable for ensuring information in systems used at study level is current and accurate
• Oversee study performance against plans and KPIs; communicate risks and mitigations to CPT and DSM
• Identify and report quality issues; coordinate CAPAs with stakeholders
• Oversee TMF completion and ensure CQAs and EDL are in place
• Ensure governance controls and audit readiness; liaison during inspections
• Provide feedback on performance and mentor less experienced colleagues
• Participate in process improvements and non-drug project work as needed
• May act as Subject Matter Expert for a process or system

Conocimientos

Project management

Team leadership

ICH-GCP knowledge

Clinical study management

Stakeholder management

Communication

Strategic thinking

Educación

University degree in medical or biological sciences

Descripción del empleo

The Global Study Associate Director (GSAD) is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the delivery of clinical studies. The GSAD is responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery. The GSAD is the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. The GSAD is accountable to the CPT 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 and/or study oversight team in accordance with the study team operating model, current clinical trial regulations (e.g. ICH GCP), Standard Operating Procedures (SOPs), policies and best practices (e.g. guidelines) and in line with values and behaviours.

Essential Functions

• Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. May hold accountability and/or oversight of several studies.
• Lead and facilitate communication across all functions, including external partners and service providers. Lead and conduct investigator meetings and other study related meetings.
• Provide input into and hold accountability for the development of essential study level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant SOPs.
• Ensure all external service providers (i.e., Contract Research Organizations (CROs), central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented and any issues are escalated appropriately. May participate in vendor selection activities.
• Develop and maintain relevant study plans including required input into study level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team.
• Accountable for ensuring that information in all systems utilized at a study-level (e.g. ACCORD/ABACUS, PharmaCM, etc.) are current and accurate.
• Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines and communicate any risks to timelines and/or quality to CPT and sDSM/DSM along with proposed mitigations.
• Identify and report quality issues that have occurred within the study in accordance with relevant SOP 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 Trial Master File (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, financial system attestations, Clinical Trial Transparency).
• The GSAD is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process).
• Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines; GSAD is the primary Study Management point-of-contact in the event of an audit or inspection.
• Provide regular feedback on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues.
• Work on non-drug project work such as being a Study Management representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manage.
• May act as Subject Matter Expert for a particular process or system within Study Management.

Qualifications

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
• 5 years of relevant clinical experience in the pharmaceutical industry, including 2 years’ project management experience, or equivalent combination of education, training and experience
• Extensive knowledge of ICH-GCP, clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development
• Demonstrated solid project management skills and knowledge of relevant tools
• 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

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.