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Harmony Biosciences · 1 day ago

Manager, Clinical Trial Operations

Plymouth Meeting, PA

Full-time

Hybrid

Mid, Senior Level

4+ years exp

Harmony Biosciences is recruiting for a Manager, Clinical Trial Operations. In this role you will manage all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out.

BiopharmaBiotechnologyHealth Care

Hiring Manager

Ellen Mancino

Responsibilities

Provides support with project completion according to overall development plan, and in compliance with all regulations, guidance, and health authority expectations

Oversees clinical trial conduct including feasibility, study start-up, enrollment, study conduct and close-out

Collaborates with the department, cross-functional teams, and external service providers that directly contribute to key study activities and milestones

Prepares and reviews study-related and essential clinical study documentation. Provides oversight and guidance if some tasks are delegated to a Clinical Trial Associate

Proactively identifies potential study risks and recommends/implements solutions

Communicates and escalates issues appropriately

Ensures clinical data from sites are of quality and delivered in accordance with expectations

Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function

Ensure the Clinical Trial Management System is complete and up to date for assigned studies

Prepares metrics and updates for management, as assigned

Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings

Serves as a liaison and resource for investigational sites

Participates in the review and implementation of departmental SOPs and processes

Participates in study-level review to support data quality and integrity

Qualification

Clinical research operationsFDA regulations/ICH guidelinesProject managementMicrosoft Office SuiteCross-functional collaborationStrategic problem-solvingEffective communicationAttention to detail

Required

Bachelor's degree required; Masters degree is preferred

4+ years of experience in clinical research in the pharmaceutical/research industry leading complex clinical research deliverables in a multi-disciplinary, cross-functional environment. Experience in more than one therapeutic area is required

Working knowledge of legal, compliance, and regulatory guidelines related to conduct of late-phase trials in the US and globally

Considers quality and attention to detail as fundamental and necessary attributes of all output and patient safety as an overarching responsibility

Strategic problem-solver with ability to identify appropriate solutions

Effective written and verbal communication skills

Proficient in the use of Microsoft Office Suite