Local Study Associate Director

Standort: Wien, Österreich

Anstellungsart: Vollzeit

Arbeitsform: Home-based

Referenznummer: R1546726

Internal Job Description

To lead Local Study Teams, LSTs, at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LSTs, the Local Study Associate Director may perform site monitoring as needed to support the flexible capacity model.

The Local Study Associate Director is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

Main Responsibilities

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of CRAs and CSAs for assigned study or studies.
• Leads and optimises the performance of Local Study Teams at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.
• Ensures clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites and investigators, performing initial Site Quality Risk Assessment and conducting Site Qualification Visits.
• Ensures timely submission of applications and documents to EC or IRB and works with Regulatory Affairs for submissions to Regulatory Authority.
• Ensures timely preparation of country financial Study Management Agreement and maintains accurate study budget in Sponsor clinical studies financial system.
• Ensures timely preparation of local Master CSA, site budgets and amendments as needed.
• Ensures timely preparation of country level Master Informed Consent Form and subsequent site level ICFs, including translations where required.
• Ensures all country and site level trial essential documents required by ICH-GCP are collected and verified before sites are ready to enrol.
• Plans and coordinates applicable local drug activities.
• Sets up and maintains the study in CTMS at study country level and local websites as required.
• Oversees, manages and coordinates monitoring activities from site activation through to study closure.
• Reviews monitoring visit reports and proactively advises monitors on study-related matters.
• Performs co-monitoring and accompanied site visits or training visits with study CRAs where required.
• Proactively identifies risks and facilitates resolution of complex study problems and issues.
• Organises regular Local Study Team meetings.
• Reports study progress and updates to the Global Study Associate Director and Global Study Team.
• Contributes to patient recruitment strategy including communication with participating investigators.
• Develops, maintains and reviews risk management plan on country study level.
• Plans and leads activities associated with audits and regulatory inspections.
• Provides input to process development and improvement.
• Collaborates with local Medical Affairs team and supports SMM in local, regional or global initiatives.

Required Skills and Qualifications

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• Minimum 3 years of experience in Development Operations, CRA or Senior CRA, or other related fields such as Medical Affairs-led or Academic-led studies.
• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
• Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and required quality.
• Good medical knowledge of Oncology, Rare Diseases, Cardiology, Hematology and CVRM Therapeutic Areas.
• Good knowledge of the Drug Development Process.
• Excellent understanding of the Clinical Study Process including monitoring.
• Very good understanding of Study Drug Handling Process and Data Management Process.
• Excellent project management skills.
• Excellent ability to prioritize and handle multiple tasks, attention to detail and negotiation skills.
• Excellent knowledge of spoken and written English and German language.
• Good ability to learn and adapt to work with IT systems.
• Ability to travel nationally and internationally as required.

Salary and Application

For candidates based in Austria, IQVIA offers a market-competitive gross annual salary starting at €58,500, depending on qualifications and relevant professional experience.

Please apply with your English CV.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA creates intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

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