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.
Requirements: Demonstrates flexibility and resilience with the ability to evolve in an always changing and challenging (internal and external) environment, processes, and systems.
Demonstrates excellent leadership skills, promoting motivation and high-quality performance of others to accomplish individual, team, and organizational objectives.
Demonstrates an excellent understanding of clinical study, drug development, sample management, and other associated processes and quality requirements.
Has a strong project management approach and demonstrated ability to work and lead in a matrix team environment involving both internal and external partners.
Proficient in acting as the organization's spokesperson to external physician investigators and other external clinical site staff, institutional review boards, etc., including responding to intricate questions.
Capable of performing well within the local setting and, if needed, in additional regional settings while encouraging positive relationships with remote central team members. Ability to work effectively in a remote environment.
Capable of establishing and coordinating priorities and performance objectives in a nearby setting and, when necessary, in additional regional settings.
This position is open to all candidates.