- 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 optimizes 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 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 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 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 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 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.
Education, Qualifications, Skills and Experience
- Bachelor 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 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.
- Excellent project management skills.
- Excellent team building and interpersonal skills.
- Excellent organizational 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.
- Good negotiation skills.
- Good ability to learn and to adapt to work with IT systems.
- Ability to travel nationally and internationally as required.
- Good medical knowledge and ability to learn relevant 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.
- Good medical knowledge and ability to learn relevant Therapeutic Areas.
- Integrity and high ethical standards.
- Good analytical skills.
- Good resource management skills.
- Good decision making and delegation skills.
- Good financial management skills.
- Basic change management skills.
- Basic coaching skills.
- Basic ability in handling crisis situations.
- Good intercultural awareness.
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