Company:  Confidential

Job Title: Senior Project Manager / Clinical Scientist

Job Number: 78535

Location: Remote, US

Job Description

Join a dynamic and expanding biopharmaceutical enterprise specializing in hematology, immunology, and neurology therapies. Lead the comprehensive execution of global clinical trials, overseeing both scientific and operational aspects spanning phase I to IV trials. Ensure strict compliance with regulatory guidelines, company protocols, and timelines, prioritizing patient safety and data integrity. Actively contribute to refining operational processes for continual improvement. Responsibilities: * Manage assigned clinical trials, ensuring adherence to predefined timelines, budget constraints, and data quality benchmarks. * Drive feasibility assessments and investigator recruitment efforts, coordinating study enrollment while aligning with budget and schedule parameters. Collaborate on crafting and reviewing recruitment materials in partnership with CRO project managers. * Maintain robust communication channels with CROs and sites, addressing protocol queries, safety reports, and study documentation per company standards. * Oversee Trial Master File setup, upkeep, and archival processes. * Provide regular progress updates to internal clinical research and cross-functional project teams. * Facilitate trial execution, encompassing setup, maintenance, and closure activities. Proactively identify and resolve patient or trial-related issues to ensure trial objectives, safety, and financial targets are met. * Develop, review, and finalize study-specific plans and documentation, including case report forms and safety event reporting. * Conduct or coordinate monitoring activities at study sites to uphold company standards. * Additional responsibilities encompass investigational product management, vendor oversight, budget management, risk mitigation, quality assurance, and meeting coordination.

Responsibilities

Responsible for ensuring that all activities are completed for assigned clinical trials to agreed timelines, budgets and data quality standards.  Activities include but are not limited to the following:  * Feasibility/Recruitment – Identification and selection of investigators willing to participate in clinical trials and managing study recruitment with respect to timelines and budget. Prepare and review study recruitment and retention materials, in conjunction with any partner CRO project manager. * Ensures prompt, quality communications with CROs/sites regarding protocol clarification and procedural queries annual (safety) reports, clinical study reports and other trial documentation, to standards required by company Ongoing data review and assisting with site issue resolution * Ensure Trial Master File is correctly set up, regularly maintained and archived * Providing regular progress updates to clinical research team and cross-functional project team  * Delivery of Clinical Trial– Includes set-up, maintenance and close-out procedures.  Ensuring prompt identification and resolution upon any patient or trial related problems to satisfactory conclusion.  Overall management of clinical trial with respect to patient safety, objectives, timelines and budget.  This includes: * Development, review and finalization of study-specific plans and forms, including case report forms and statistical analysis plans * Ensure correct reporting of safety events * Monitoring/co-monitoring at study sites to standards required by company Additional responsibilities will include: Investigational Medicinal Product (IMP) and Supplies Management CRO and Vendor Management Budget Management Risk Management Strategies Quality Assurance and Audits Meeting Management

Required Skills

Required Skills: * Proficient in Good Clinical Practice and regulatory compliance requirements. * Possess a science degree or equivalent qualification. * Demonstrated experience in clinical research within the pharmaceutical or related industries, with at least 6 years in study management roles.Expected salary range: $160,000 – $180,000 annually, inclusive of bonus and comprehensive benefits package.

Application Deadline: 2024-06-03

 

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