IQVIA

Job Overview

Local Clinical Project Manager(s) at country level to deliver committed components of clinical studies, according to agreed resources, budget, and timelines.

In addition, the Local Clinical Project Manager( CPM) may perform site monitoring as needed to support the flexible capacity model.

The CPM 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.
• CPM 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.
• 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, clinical studies financial system by regular checks of the system and financial report
• 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 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 sitesready to enrol, and in line with 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 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. 
• 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 meetings, in line with local codes, as required. • Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies. 
• Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at country level. 
• Ensures accurate payments related to the study are performed according to local regulations and agreements. 
• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and Procedural Documents. 
• Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline manner to maintain the eTMF “Inspection Ready”.
• 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/ies and planned study milestones/key issues. 
• Updates Line Managers about the performance of the CRAs/CSAs. 
• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. 
• Collaborates with local Medical Affairs team.
• Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

Education:

• Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification.
• Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies). 
• Good knowledge of international guidelines ICHGCP as well as relevant local regulations.
• Excellent project management skills. 
• Excellent team building and interpersonal skills. 
• Excellent verbal and written communication skills. 
• Excellent ability to prioritize and handle multiple tasks. 
• Excellent attention to details. 
• Excellent knowledge of spoken and written English and local language.
• Good negotiation skills. 
• 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 advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com