Country Study Specialist - Senior CRA

Main Responsibilities and Accountabilities:

· Coordinates/supports operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring quality and safety standards, regulations, timelines and budget commitments are met.

· Performs/coordinates protocol and site level feasibility activities, including evaluation of patient population and final site selection (if applicable).

· Provides input into and/or develops study related materials such as Monitoring Plans, Recruitment Plans and Study Newsletters.

· Supports/coordinates the negotiation of site budgets within Fair Market Value (FMV) guidelines, budget plans and provides oversight for site payments per contract, as required.

· Maintains effective and ongoing communication with CSM; supports communication with local study teams and to sites as required.

· Works with the global study team and CSM to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of non-productive sites and tracking of safety procedures.

· Supports management of country-level Trial Master File (TMF) and reviews for quality (including translations, as applicable).

· Is responsible for the co-ordination and oversight of hub/country level audit/inspection action plan activities.

· Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.

· Executes all start-up activities prior to site activation on assigned studies, according to company standards and aligned with study/project requirements and timelines.

· Prepares country and/or site Informed Consent Form (ICF) and clinical study documents which need translation from English into local language.

· Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.

· Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies/ laws, via innovative approaches

· Submits, where applicable and according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SUSARs), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs) in collaboration with LSR.

· Participates in study budget process and is responsible for contracts negotiation in collaboration with Business Support Leader and Country Study Manager, as required and ensures compliance with Fair Market Value (FMV) in the country.

Job Type: Full-time