לוח משרות דרושים CRA למחקרים קליניים

As a Country Approval Specialist, you will participate in the management and preparation, review and coordination of Country Submissions in line with global submission strategy in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.

Supporting the facilitation of site start up and communication with internal and external team mem-

bers to ensure prompt site approval and study timelines are achieved.

Support sites and study teams to achieve rapid site start up

Essential Functions:
Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
Provides project specific local SIA services and coordination of these projects.
May have contact with investigators for submission related activities.
Key-contact at country level for either Ethical or Regulatory submission-related activities.
Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
Achieves PPDs target cycle times for site.
May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
May develop country specific Patient Information Sheet/Informed Consent form documents.
May assist with grant budgets(s) and payment schedules negotiations with sites.
Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff, and external clinical site staff involved in study preparation and delivery providing both matrix leadership and project management of study activities within the country(ies).
Serves as the operational point-of-contact between the central study team and within-country(ies) study team. The LDL collaborates closely with local medical and regulatory affairs staff to align local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within country(ies). Leads selection of sites within country(ies) and is accountable for local study performance.
Accountable for within-country delivery of assigned studies to time, budget, and quality expectations as defined in the clinical development plan and study protocol as well as in local/regional regulations, IND/GCP/ICH-guidelines, and procedures. Ensures quality and integrity of clinical studies by taking on appropriate business management monitoring activities.
Ensures development and maintenance of country study plan and that critical study timelines related to study activities within-country(ies) are accurately forecasted and achieved, including budgets, resource estimates, milestones, timelines, quality and risk planning, and that recruitment targets, patient recruitment cycle times, data, and audit/inspection quality are met. Provides troubleshooting and problem resolution support for within-country study team to ensure productive, efficient study delivery. Ensures necessary supplies are available at sites and manages local supply inventory.
Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders and to specify and review in-country study monitoring tracking tools, monitors key risk and performance indicators, and other reports. Review all study databases to ensure 100% accuracy.
Ensures development of country/site-level risk assessment to proactively identify risks, develop a mitigation plan, and escalate issues and risks that may impact study delivery.
Will review and approve monitoring visit reports and ensure appropriate site monitoring activities have been completed per the study monitoring plan.
May provide feedback on performance, capabilities, and competencies of local study members to line management.