***Must have pharmaceutical company work experience***
Position Summary: This position will be responsible for coordinating and executing clinical trial, regulatory, and program management activities. This position is responsible for the successful execution of clinical trials from the protocol concept through the clinical study report per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements across the globe. In addition, the individual will contribute to the development of SOPs, clinical development plans, and other company initiatives as required.
Essential Duties and Responsibilities:
Manage clinical studies encompassing all aspects from start-up through close-out (reconciliation of Trial Master File)
Develops and manages comprehensive study timelines and metrics
Drives selection and management/oversight of external vendors including key performance indicators and participates, as applicable, in vendor management and governance
Assists in development of clinical study synopsis and protocols in conjunction with the clinical development plan and GCP guidelines and regulations
Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs
Ensures audit-ready conditions of clinical trial documentation including trial master file
Coordinates and assists in the planning of regulatory or ethics committee activities for the clinical study, as appropriate
Participates in the planning of quality assurance activities and coordinates resolution of audit findings
Proactively identifies and resolves issues and manages escalation and mitigation as appropriate
Coaches and provides guidance to clinical staff, may have management responsibilities for clinical trial management staff
Works cross functionally to develop internal work processes
Supervisory Responsibilities: This position may supervise employees.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education, Experience and Certifications:
Bachelor’s Degree in science or a health-related field is required; advanced degree preferred
5-10 years of experience in the biotech/pharmaceutical industry
Must have experience as a study manager
Experience in multiple therapeutic areas or disease state/indications desirable, including life cycle management
Strong management skills, and ability to effectively lead and collaborate with both internal and external stakeholders
Excellent written and oral communication skills
Demonstrated leadership, problem solving, conflict resolution, and team building skills
Excellent knowledge of GCP, ICH, and FDA regulations with direct experience with health authority inspections
Language Skills: Must have strong oral and written communication skills. The ability to write in-depth proposals and technical reports that require knowledge in the biological sciences, clinical trial and drug product life-cycle, and detail project structure, procedures, and outcomes is critical. Must be proficient in Microsoft Office software (Word, Excel, PowerPoint, Project, and Outlook). Ability to effectively present information in one-on-one and group settings.
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