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Edgewise Therapeutics · 2 weeks ago

Senior Manager/Associate Director, Clinical Operations (EDG-2026002)

United States

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$140K/yr - $195K/yr

8+ years exp

Edgewise Therapeutics is dedicated to discovering new medicines for patients with serious muscle diseases. The Senior Manager/Associate Director of Clinical Operations will provide operational expertise and strategic input for clinical trials, overseeing budgets, timelines, and vendor management to ensure successful study execution.

BiopharmaBiotechnologyHealth Care

Responsibilities

Provide operational expertise and strategic input for assigned clinical trials

Provide expertise and operational input into protocol synopsis, final protocol, Informed Consent and other study related documents

Independently creates and manages budgets, forecasting, and monitoring for assigned studies

Oversee country and site feasibility/selection process, with a focus on providing country insights, corporate agreement, and therapeutic expertise to ensure understanding between study execution plan and program strategy

Provide strategic input and management of site activation activities and recruitment strategies

Oversight of study timelines to ensure the needs of the clinical development plan are met

Oversee strategic partners/CRO/vendor selection, budget and contract negotiation, and proper guidance of performance for all activities assigned to a strategic partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted

Approval of essential monitoring documents/plans, periodic review of outputs and actions related to monitoring

Study team meeting management and attendance; regular review of meeting agendas and minutes

Review outcomes/actions related to protocol deviations review; primary purpose of review is to help identify trends across sites or the study

Identify, monitor and review operational risks and decisions at the study level and implementation of mitigation strategies. Oversee site KPIs, protocol deviations and metrics to identify trends and maintain data quality. Escalate site level risks or non-compliance, and in collaboration with Quality Assurance, review Site Corrective and Action Plans (SCAPAs), Corrective and Action Plans (CAPAs) and Site Audits

Maintains cross-functional partnership to test all database timelines and plans; ensure linkage between the strategy (i.e., filing/registration, data generation) with the tactical plan for database lock and CSR

Contributes to drafting Standard Operating Procedures (SOPs) and adheres to Clinical Operations processes and SOPs to ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and attending the inspections

Support onboarding, mentor and manage direct reports within the department

May collaborate with other functional leads to manage project related efforts. Participates in departmental quality or process improvement initiatives

Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures

Perform other duties as assigned by supervisor

Qualification

Clinical trial designClinical operations experienceProject managementGCP knowledgeFDA regulationsEMEA regulationsICH guidelinesCommunication skillsMentoringCross-functional collaboration

Required

Bachelor's Degree (Life Sciences)

At least 8+ years of relevant clinical operations experience in clinical trial design and conduct, with minimum of 6 years at a biotech or pharmaceutical company

Experience must include Phase 2 and 3 studies (globally recruited)

In-depth knowledge of clinical research operations, including GCP, FDA and/or EMEA regulations, and ICH guidelines

Excellence in project management and communication