IQVIA
LocalStudyAssociateDirector
Neural analysis suggests this role is
optimal for Mid candidates.
“Local Study Associate Director at IQVIA. Skills: Process management, Cross-functional coordination, Vendor/stakeholder management. Lead Local Study Teams (LSTs) at country level. Deliver committed components of clinical studies”
What You'll Achieve.
Deliver committed components of clinical studies according to agreed resources, budget and timelines; Timely delivery of data to required quality; Ensure compliance with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations
Industry & Context.
Proactively identifies risks and facilitates resolution of complex study problems and issues
Ability to travel nationally and internationally as required, Candidates based in Vienna, Austria will be considered
What They're Looking For.
Must Have
Bachelor degree in related discipline, preferably in life science, or equivalent qualification, Minimum 3 years of experience in Development Operations (CRA, Sr CRA) or other related fields (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 with required quality, Good medical knowledge of Oncology, Rare Diseases, cardiology, hematology, CVRM Therapeutic Areas, Good knowledge of the Drug Development Process, Excellent understanding of the Clinical Study Process including monitoring, Very good understanding of the Study Drug Handling Process and the Data Management Process, Excellent project management skills, Excellent ability to prioritize and handle multiple tasks, attention to details and negotiation skills, Excellent knowledge of spoken and written English and German language, Good ability to learn and to adapt to work with IT systems, Ability to travel nationally and internationally as required
What You'll Do.
Lead Local Study Teams (LSTs) at country level
Deliver committed components of clinical studies
Ensure sites are identified
Archive documentation
Perform site monitoring as needed
Ensure timely delivery of data to required quality
Lead and optimise performance of Local Study Team(s)
Ensure compliance with Sponsor Procedural Documents
ICH-GCP and local regulations
Ensure clinical and operational feasibility assessment
Coordinate site selection process
Ensure timely submission of application/documents to EC/IRB
Ensure timely delivery of application/documents to Regulatory Authority
Ensure timely preparation of country financial Study Management Agreement
Maintain accurate study budget
Ensure timely preparation of local Master CSA
Ensure timely preparation of country level Master Informed Consent Form
Collect and verify trial essential documents
Plan and coordinate local drug activities
Set up and maintain study in CTMS
manage and coordinate monitoring activities
Review monitoring visit reports
Perform co-monitoring
Accompanied Site Visits/training visits
Proactively identify risks and facilitate resolution
Organise regular Local Study Team meetings
Contribute to patient recruitment strategy
maintain and review risk management plan
Communicate and co-ordinate with National Co-ordinating Investigator
Plan and lead National Investigator meet
Ensure study documents are ready for final archiving
Complete local part of the eTMF
Plan and lead activities associated with audits and regulatory inspections
Provide input to process development and improvement
Provide regular information to Line Managers
Update Line Managers about performance of CRAs/CSAs
Ensure study activities comply with local policies
Provide feedback on research related information
Ensure compliance with Sponsor´s Code of Ethics
Collaborate with local Medical Affairs team
Support SMM in different initiatives
How You'll Work.
Team & Collaboration
Lead Local Study Teams; Work with CRA(s), CSA(s); Work with Regulatory Affairs; Work with Director, SMM/ Director, Country Head; Work with study CRAs; Work with Global Study Associate Director/ Global Study Team; Work with participating Investigators; Work with National Co-ordinating Investigator / National Lead Investigator; Work with CQAD and QA; Work with Line Managers; Work with local Medical Affairs team
Communication Scope
Excellent knowledge of spoken and written English and German language; Excellent ability to prioritize and handle multiple tasks, attention to details and negotiation skills
Process & Methodology
Excellent project management skills, Resource planning, Budget management, Timeline management, Risk management
Full Job Description
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 LST(s), 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 CRA(s), CSA(s), for assigned study/studies * Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations. * Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality. * Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks. * Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations. * Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head. * Ensures timel
Applying for this Local Study Associate Director role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about IQVIA?
Real rants from real employees. Read before you apply.