Local Clinical Project Manager (Sponsor dedicated)

The Local Clinical Project Manager (Sponsor dedicated) will lead 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, and relevant local regulations.

The Local Clinical Project Manager may perform site monitoring as needed to support the flexible capacity model. The Local Clinical Project Manager is responsible for ensuring that sites are identified, site qualifications performed, set up, initiated, monitored, closed, and documentation archived.

Main Responsibilities:

• Has overall responsibility for 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 Local Study Team at country level, ensuring compliance with Sponsor Procedural Documents, ICH-GCP, and local regulations.
• Ensures clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates 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.
• 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 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 Monitoring Plans.
• Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advises 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's degree in a related discipline, preferably in life science, or equivalent qualification.
• At least one year's experience in Clinical Project Management at Local level.
• Very good knowledge of Oncology 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.
• Excellent understanding of 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 Portuguese and English language.
• Good ability to learn and adapt to work with IT systems.
• Ability to travel nationally and internationally as required.