Global Study Associate Director - Single Sponsor dedicated

IQVIA; Madrid; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Global Study Associate Director to lead cross-functional study teams within Clinical Operations. This role oversees timelines, budget and quality, partnering with CPT and external vendors to drive successful study delivery from handover to close-out.

The GSAD ensures regulatory compliance, quality standards and effective communication across all functions, mentors staff, and supports process improvements across study management activities.

Formación

• University degree in a medical/biological sciences field or related clinical research discipline.
• 5 years of relevant clinical experience in pharma, including 2 years in project management or an equivalent combination of education and experience.

Responsabilidades

• Lead cross-functional study teams to deliver milestones on time within budget and quality standards.
• Facilitate communication across all functions and with external partners; lead investigator meetings.
• Contribute to development of essential study documents from CSP to CSR per SOPs.
• Oversee external service providers (CROs, labs, IXRS, ePRO) to meet goals; participate in vendor selection.
• Develop and maintain study plans including quality and risk management; define risk mitigation strategies.
• Ensure information in study systems (ACCORD/ABACUS, PharmaCM) is current and accurate.
• Monitor study performance against plans and KPIs; report risks with mitigations to CPT and DSM.
• Identify and report quality issues; coordinate CAPAs with stakeholders.
• Oversee TMF completion; ensure TMF plan and EDL exist and QC is ongoing.
• Ensure governance controls (DAO, Sunshine Act, financial attestations) are complied with.
• Budget re-forecasting and management; provide budget progress reports to CPT with risks.
• Maintain inspection-readiness; act as primary contact during audits/inspections.
• Provide feedback and mentoring to team members; support professional development.
• Contribute to non-drug project work and process improvement initiatives.

Conocimientos

Cross-functional leadership

Project management

Educación

University degree (medical/biological sciences or clinical research related)

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