(Associate) Local Study Project Manager

IQVIA LLC; Warszawa; On-site; PLN 172,000 - 419,000; Full time

Job summary

IQVIA is seeking an Associate Local Study Project Manager (Sponsor dedicated) to lead Local Study Teams at country level, delivering study commitments within budget and timelines under ICH-GCP and local regulations.

The role may include site monitoring to support flexible capacity and ensuring site setup, qualification, initiation, monitoring, and archiving of documents. Strong English and Polish language skills required, with travel as needed.

Qualifications

• Bachelor degree in related discipline (life science preferred)
• At least 1 year of clinical project management experience at local level
• Very good knowledge of Oncology or Respiratory therapeutic area
• Proven ability to lead cross-functional teams to deliver trials on time and within budget
• Clinical Trial Phase III experience
• Excellent understanding of the Clinical Study Process including monitoring
• Excellent project management skills
• Strong prioritization and multitasking abilities
• Fluency in English and Polish (spoken and written)
• Willingness to travel nationally and internationally

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 studies.
• Leads performance of the Local Study Team at country level ensuring compliance with SOPs, ICH-GCP and local regulations.
• Ensures that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates site selection by identifying potential sites/investigators and conducting Site Qualification Visits.
• Ensures timely submission of application/documents to EC/IRB at start up and throughout the study.
• Works with Regulatory Affairs for submissions to Regulatory Authority.
• Prepares country financial Study Management Agreement and maintains the study budget.
• Prepares local Master CSA and amendments as needed.
• Prepares country level Master Informed Consent Form and site ICFs, including translations.
• Ensures all trial essential documents required by ICH-GCP prior to start are collected.
• Plans and coordinates applicable local drug activities (purchase, reimbursement, destruction).
• Sets up and maintains the study in CTMS at country level and local websites as needed.
• Oversees monitoring activities from site activation to study closure per Monitoring Plans.
• Reviews monitoring visit reports and advises monitors on study matters.
• Performs co-monitoring and site visits with CRAs as required.
• Identifies risks and facilitates resolutions of complex study problems.
• Organises regular Local Study Team meetings.

Skills

Cross-functional leadership

Clinical trial management

Project management

English and Polish proficiency

Site monitoring

Regulatory knowledge

Oncology/Respiratory knowledge

Education

Bachelor degree in life science or related field

Tools

CTMS

Job description

Associate Local Study Project Manager (Sponsor dedicated)

The (Associate) Local Study Project Manager (Sponsor dedicated) will be leading Local Study Teams 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 the Local Study Teams, the (Associate) Local Study Project Manager may perform site monitoring as needed to support the flexible capacity model.

The LSAD 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 studies.
• Leads the performance of the Local Study Team at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.
• Ensures 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.
• 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, including any relevant translations.
• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected.
• 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.

Required Skills and Qualifications

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• At least a year of experience in Clinical Project Management at local level.
• Very good knowledge of Oncology or Respiratory therapeutic area.
• 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.
• Clinical Trial Phase III experience.
• Excellent understanding of the Clinical Study Process including monitoring.
• Excellent project management skills.
• Strong ability to prioritize and handle multiple tasks, attention to details and negotiation skills.
• Very good knowledge of spoken and written English and Polish language.
• Good ability to learn and to adapt to work with IT systems.
• Ability to travel nationally and internationally as required.

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.

"The potential base pay range for this role, when annualized, is 171 500,00 zł - 418 600,00 zł. 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.