Global Study Associate Director - Sponsor Dedicated at IQVIA

Barcelona, Catalonia, Spain

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Clinical Research, OncologyIndustries

Requirements

The Global Study Associate Director (GSAD) should have a minimum of 8 years of experience in a similar role, preferably in a pharmaceutical or biotechnology company
The GSAD should have a strong understanding of clinical trials regulations, including ICH GCP and Sponsor Standard Operating Procedures (SOPs)
The GSAD should be familiar with the Study Delivery Operating Model (SOLID) and the Study Team Operating model for Internal Delivery (SOLID)
The GSAD should have excellent leadership and communication skills, with the ability to lead and coordinate a cross-functional study team
The GSAD should be able to facilitate communication across all functions and provide guidance and support to study team members as needed
The GSAD should have experience with outsourced studies and be the primary sponsor point of contact for the Clinical Research Organization (CRO) Project Manager
The GSAD should be able to develop and maintain relevant study plans, including quality and risk management planning
The GSAD should have excellent project management skills, with the ability to use company tracking systems and project timelines to oversee study level performance
The GSAD should be able to identify and report quality issues that have occurred within the study and collaborate with all functions to overcome barriers and achieve milestones
The GSAD should be able to ensure timely compliance with company-wide governance controls, including Delegation of Authority, Sunshine Act, budget attestations, and CRO SOPs

Responsibilities

Lead and coordinate a cross-functional study team of experts in accordance with SOLID and its roles, accountabilities and responsibilities framework (RACI) to ensure clinical study progress as planned
Lead and facilitate communication across all functions and provide guidance and support to core and extended study team members as needed and in accordance with study-specific communication plan
Be the primary sponsor point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget, and quality standards
Provide input into and hold accountability for the development of essential study level documents, including Clinical Study Protocol (CSP) and Clinical Study Report (CSR)
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
Develop and maintain relevant study plans, including global study management plan and its relevant components such as study project plan SPP
Oversee study level performance against agreed upon plans, milestones, and key performance indicators (KPIs, quality, and operational) using company tracking systems and project timelines
Identify and report quality issues that have occurred within the study in accordance with relevant Sponsor 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.)
Ensure timely compliance with company-wide governance controls, including Delegation of Authority, Sunshine Act, budget attestations, CRO SOPs, and ICH GCP

Skills

Key technologies and capabilities for this role

ICH GCPSOLIDStudy Delivery Operating ModelSponsor Project ManagementClinical Trial RegulationsSOPsCRO OversightCross-functional Team LeadershipRACIStudy Team Management

Questions & Answers

Common questions about this position

What is the employment type for this role?

This is a full-time position.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What are the key responsibilities of the Global Study Associate Director?

The role involves leading a cross-functional study team, ensuring study delivery per timelines, budget, and quality standards, acting as liaison with the Clinical Program Team, and overseeing external service providers in accordance with SOLID and relevant SOPs.

What is the team structure for this position?

The role leads a cross-functional study team (core and extended) and may oversee a study oversight team, following the SOLID Study Team Operating model and RACI framework.

What experience or skills make a strong candidate for this role?

Strong candidates should have expertise in leading cross-functional clinical study teams, knowledge of clinical trial regulations like ICH GCP, experience with study delivery models such as SOLID, and skills in managing outsourced studies and external vendors.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

Land your dream remote job 3x faster with AI

Try Jobo Free