The LSMS will be responsible 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 RWE
In addition LSMS may perform site monitoring as needed to support the flexible capacity model. LSMS is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
Implementation of clinical studies :
Has the overall accountability for the study commitments within the country and for timely delivery of data to required quality.
Coordinates and optimizes the performance 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.
Discusses and assist the Evidence Generation Manager on the selection of potential sites to participate in studies, collecting and providing all relevant information to support this definition.
Responsible for timely submission of application / documents to EC at start up and for the duration of the study.
Responsible for timely preparation of CSA (including amendments as needed) and follow-up of agreed milestones.
Ensures timely elaboration 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.
Guarantees the appropriate input and revision of all applicable stakeholders (Evidence Generation Manager and Study Scientific Leader).
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 enrol, and in line with Sponsor SOPs.
Sets up and maintains the study in CTMS and other applicable platforms at study country level as required by local laws and regulations, as well as all applicable study Plans and documents.
Study conduct and closure
Oversees and coordinates monitoring activities from site activation through 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.
Plans and leads National Investigator meetings, in line with local codes, as required.
Proactively identifies risks and facilitates resolution of complex study problems and issues. Escalates issues to the Evidence Generation Manager as applicable.
Organises regular Local Study Team meetings on an agenda driven basis.
Reports study progress / update to the Evidence Generation Manager on a weekly basis, concerning study / ies KPIs, milestones and key issues
Define in collaboration with Evidence Generation Manager patient recruitment goals and strategy and oversees and coordinates goals and strategy implementation, including regular communication with CROs / participating Investigators as needed
Develops, based on Sponsor templates, for Evidence Generation Manager Validation study plans and ensure updates : Sponsor Oversight Plan, Study Communication Plan, Study Collaboration Plan, Risk management Plan, TMF Plan, Monitoring Plan, Corrective / Preventive Plans.
Ensure the elaboration and updates of other study plans ( eg. Safety Handling Plan, Data Management Plan, Statystical Analysis Plan)
Works together with stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
Assists in forecasting study timelines, resources, recruitment, study materials and drug supplies.
Ensures accurate payments related to the study are performed according to local regulations and agreements.
Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline manner to maintain the eTMF Inspection Ready .
Provides feedback on any research related information including sites / investigators / competing studies that might be useful for the local market.
Ensure service providers oversight (eg .CROs) - confirm service delivery is in line with the agreed timelines and quality.
Collaborates with local Medical Affairs team.Ensures compliance with Sponsor Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment)
Bachelor’s degree in relevant discipline
3 to 5 years of experience of Study Management within a pharmaceutical or clinical background
Previous experience with start-up activities in Portugal (from initial contracts with responsible CROs until Site’s initiation).
Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management