Manager, Clinical Study Lead

Responsibilities Accountable for global execution of assigned smaller/less complex clinical trials (including Phase IV/Real World Evidence) from study design through close-out; ensure timelines and budget, and study conduct per SOPs and ICH/GCP. Lead cross-functional study team for clinical study delivery; oversee execution against timelines/deliverables/budget; raise issues and implement corrective actions. Provide operational input into protocol development; lead feasibility assessments; oversee site evaluation/selection; lead investigator meeting preparation/execution. Oversee study documentation (e.g., CRFs, data management plan, monitoring plan/oversight plan, training plan, data review plan, SAP). Set up/maintain study systems (e.g., CTMS, TMF) and ensure clinical trial registry compliance. Identify outsourcing needs; lead vendor engagement, contracting, and management to ensure CRO/vendor delivery per scope. Provide input into baseline budget/timeline; manage budget and scope change control. Lead study-level risk assessment/mitigation; monitor site activation/visits and deviations; oversee recruitment/retention strategies; monitor data entry/query resolution. Manage close-out activities (database lock, reconciliation of contracts/budget/TMF, study drug accountability); contribute to clinical study report writing/review; facilitate lessons learned. Assign tasks to Clinical Study Management staff; directly supervise CTM staff; support deliverables and continuous improvement. May perform unmasked-study tasks (e.g., unmasked TMF setup/management, IVRS issue point of contact, oversight of unmasked monitoring). Qualifications Bachelor’s degree; at least 6 years relevant industry experience. Extensive budget management; experience building study teams/collaborations; demonstrated vendor management. Technical proficiency with trial management systems and Microsoft (Project, PowerPoint, Word, Excel); IVRS/IWRS and EDC. Global clinical trial operations experience (protocols and key study documents); solid ICH/GCP and regulatory knowledge; project management and cross-functional leadership. Ability to implement operational strategic direction/guidance for clinical studies. Preferred Experience with Phase IV / RWE. #J-18808-Ljbffr