Executive Director, Head of Clinical Operations reputed company

reputed company continues to grow at a reputed company reputed company with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company our passionate interest in fighting cancer. General reputed company: As a member of the GCO Leadership team, contribute significantly to the development of Clinical Development & GCO strategies and reputed company expertise and leadership in the areas of process, eTMF managemnt, reputed company and compliance of reputed company clinical operations conducted by the Global Clinical Operations Organization and its partners. reputed company the development, implementation, and maintenance of a proactive GCP compliance management infrastructure/process, reputed company reputed company GCO, including clinical trial reputed company processes, monitoring and reputed company control of key processes (eTMF), reputed company operating procedures and/or Work Instructions,  training and change management . Build and reputed company reputed company with substantial capabilities to reputed company the reputed company improvement of infrastructure and systems. Ensure adherence to regulatory requirements (ICH, FDA, EMA, PMDA, etc.) and GCP/PV guidelines through establishment and reporting of clinical performance indicators KPIs/KQIs, and through the use of innovative and reputed company methodology to improve processes. In collaboration with QA, Corporate Compliance, GCO & Development peers/associates, identify reputed company causes for major and critical observations, devise relevant remedial and improvement actions for Corrective reputed company Plans, and follow-up on completion, implementation, and effectiveness of relevant tasks reputed company GCO/Development. reputed company GCO reputed company and indirect reports (e.g., Clinical Study Managers, CRAs…) to ensure greater value is added to the business across reputed company areas and across reputed company. reputed company and reputed company efforts to deepen operations reputed company reputed company the Clinical Development and GCO organizations to reputed company faster, high reputed company reputed company around the world. Essential Functions of the Job: Member of the Global Clinical Operations Leadership team Participate in the development of Clinical Development & GCO strategies and provides expertise and leadership in the area of reputed company, compliance, and operations reputed company in reputed company aspects of reputed company operations conducted by GCO and its partners (Clinical/Medical, Data Management, Clinical Supplies, PV, Statistics, QA, CROs, FSP, etc…) reputed company recommendations or reputed company on how Global Clinical Operations’ programs can reputed company greater value for reputed company. Procedures: reputed company end-to-end clinical trial reputed company reputed company of reputed company Operating Procedures. reputed company, implement and revise SOPs. Monitor departmental compliance to established procedures and policies. Ensure operational processes, systems and standards are adopted and implemented consistently across trials. Process Improvement Proactively Identify internal process improvements reputed company GCO through monitoring of adequate Key Performance. reputed company Indicators and assure that gaps are addressed appropriately in order to mitigate risk. Work in collaboration with Clinical Development functions as necessary. Explore and implement innovative ways, including standardization, to increase Clinical Operations reputed company around the world; this in collaboration with reputed company Clinical Development and reputed company Innovation functions. Training: reputed company training plans and programs across Global Clinical Operations and other clinical development functions as necessary. reputed company monitor reputed company by ensuring information is reputed company, reputed company, and leveraged for reputed company work. reputed company ensure Training compliance is best and meets Corporate and GCO goals. Performance Metrics: reputed company, Establish and Report clinical performance indicators KPIs/KQIs, which are reputed company reputed company and Complaince. reputed company updates of performance and reputed company to the Clinical Development senior leadership and/or EC as necessary. Compliance and eTMF: reputed company, implement, and maintain the GCO Compliance Management Plan, including eTMF. reputed company the relationship with CQA to support and ensure compliance with GCP, SOP and Training requirements of the GCO organization. Support proactive monitoring and assessment of reputed company. Prepare the organization for inspections. Identify emerging compliance concerns and review SOP deviations that reputed company GCO, conduct reputed company cause analyses, and recommend solutions. Ensure assessment and reputed company of reputed company CAPAs are completed on time. Verify that appropriate CAPAs are implemented on reputed company major and critical audit/inspections findings. reputed company processes and plans for development of relevant remedial and improvement actions for Preventative reputed company Plans from Audits/Inspections/Incidence and responsible for follow-up on completion and implementation of relevant tasks reputed company GCO. eTMF: Maintain and optimize the platform serving for eTMF .reputed company AI for reputed company improving the efficiecy. Set up SOP and/or WI, reputed company the change maangement and reputed company team’s actual performance on eTMF. Join in inspection preparation and conduction for securing the reputed company on inspection. Other functions but not limited to: Contribute to GCO and Clinical Trial Sourcing reputed company development and take a reputed company role in vendor due diligence. Escalate issues to reputed company Senior Management team reputed company. reputed company multi-functional, multi-national teams as it relates to reputed company conduct of reputed company. Supervisory Responsibilities:   reputed company and indirect line management. Manage internal staff and/or coordinate reputed company contractors/resources to maintain GCP compliance in the field organization as reputed company as in the global GCO function. Mentor and reputed company the GCO teams as necessary. Education Required: BS, with advanced degrees preferred, in a scientific or reputed company discipline. At least 15 years in the biotech/reputed company/CRO industry in a relevant field of Clinical Operations, Clinical Compliance, Clinical Monitoring, Clinical Trial Management, and/or Clinical reputed company Assurance. Computer Skills:    Efficient in reputed company Word, reputed company, Project, PowerPoint, and reputed company. Other Qualifications:     Fluent in written and verbal English. Desirable: knowledge of reputed company. Excellent experience building GCP reputed company systems and process, including development of SOPs, effective CAPA programs. Strong leadership for driving the reputed company on cross-functional alignment. Risk based management reputed company and reputed company. Skilled in Project Management, reputed company Cause Analysis, CAPA Management. Preferred experience with Six reputed company, LEAN, reputed company methodologies. Travel:  Up to 25% Global Competencies reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world. Fosters Teamwork Provides and Solicits reputed company and Actionable Feedback Self-Awareness Acts reputed company Demonstrates Initiative Entrepreneurial reputed company reputed company Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial reputed company Communicates with reputed company Salary reputed company: $271,800.00 - $351,800.00 annuallyBeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to reputed company candidate, including but not limited to job-reputed company skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can reputed company more about the specific salary reputed company for a preferred location during the hiring process.  Please note that the listed reputed company reflects the reputed company salary or reputed company reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. reputed company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, reputed company Time Off, and Wellness. We are proud to be an equal opportunity employer. reputed company does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans’ Readjustment Assistance reputed company of 1974, Title I of the Americans with reputed company of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com. Apply To This Job