Local Study Associate Director

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 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 timely preparation of local Master CSA (including site budget) and amendments as needed.

• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs as required including any relevant translations and in line with relevant Sponsor SOPs and local regulations.

• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness prior to setting sites ready to enroll and in line with Sponsor SOPs.

• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).

• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.

• Oversees manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.

• Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advices the monitor(s) on study related matters.

• Performs any required co-monitoring Accompanied Site Visits/training visits with study CRAs.

• Proactively identifies risks and facilitates resolution of complex study problems and issues.

• Organises regular Local Study Team meetings on an agenda driven basis.

• Actively works towards achieving good personal relationships with all Local Study Team members sites staff and global stakeholders.

• Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.

• Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.

• Develops maintains and reviews risk management plan on country study level: proactively manages sites stakeholders local and global vendors and customers to ensure risks are timely identified mitigated and managed.

• Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters if applicable.

• Plans and leads National Investigator meet Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.

• Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.

• Provides input to process development and improvement.

• Provides regular information to Line Managers at country level on study and planned study milestones/key issues.

• Updates Line Managers about the performance of the CRAs/CSAs.

• Ensures that study activities at country level comply with local policies and code of ethics.

• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.

• Ensures compliance with Sponsors Code of Ethics company policies and procedures relating to people finance technology security and SHE (Safety Health and Environment).

• Collaborates with local Medical Affairs team.

• Supports SMM in different initiatives (local regional or global) as agreed with the SMM Line Management.

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 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 Italian language.

• Good ability to learn and to adapt to work with IT systems.

• Ability to travel nationally and internationally as required.

Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.

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

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.

The potential base pay range for this role when annualized is-. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge skills education and experience; location; and/or schedule (full or part-time). Dependent on the position offered incentive plans bonuses and/or other forms of compensation may be offered in addition to a range of health and welfare and/or other benefits.

Required Experience:

Director

Employment Type : Full-Time
Experience: years
Vacancy: 1