Clinical Affairs Program Manager

Clinical Affairs Program Manager #clinicalresearch #clinicaltrials #clinicaldataanalyst #REGULATORYaffairs #medicalcoding #medicalbilling #research #healthcare #medicalresearch #clinicaltrial #science #clinical #health #clinicalstudies #pharma #medical #pharmacy #biotech #clinicareers #pharmacovigilance #pharmaceuticals #clinicalstudy #pharmacovigilance #medicalaffairs #clinicalresearchassociate #pharmaindustry #doctor #phd #oncology #drugdevelopment #cra #biotechnology # Nothing in this job description restricts managements right to assign reassign duties and responsibilities to this job at any time. Responsible fcomprehensive global clinical study(ies) management, consisting of, not limited to: Conducting clinical research programs in accordance with approved project plan, compliance to company standard operating procedures and applicable regulations. Clinical project planning and management in keeping with the global corporate directive and strategic goals. Overall project budget and timeline Developerpment and execute accordingly. Accountable fachieving enrollment targets and patient follow-up commitments. Able to adapt and execute should strategic goals shift during the life of the project. Experience in detecting project risks and capable of addressing with mitigation plan and alternative solutions. Provide Quality Assurance support and management level representation during audits and inspections. Analyze and Developerp action plans finvestigational sites, vendand administrative issues. Developerp project-tracking systems and provide accurate progress reports on assigned studies and sites. Continually assess study site issues, implement corrective action, and document results. Oversee and contribute to Developerpment of key study documents including, but not limited to study protocols and protocol synopses, protocol amendments, study plans and procedure manuals, project tools, informed consent forms and clinical study reports. Accountable fCRF and database Developerpment process, accurate and timely quality data collection and monitoring. Lead and mentCRAs in activities and functions as necessary to support assigned projects. Ensure PI and site personnel engagement are adequately maintained. Screen and recruit clinical research investigators (and laboratories, as applicable). Screen, recruit, qualify, train, and monitinvestigators and their staff fstudy participation and protocol compliance. Developerp appropriate budgets, negotiate contracts and prepare agreements fthe conduct of clinical trials at investigative centers. Interact with site and central IRBs and ECs to ensure study document approval in a timely manner, leading to site activation. Plan, prepare and present at Investigatand Research CoordinatMeetings. Organize and assist with the implementation of investigatmeetings (as applicable). Work with investigative sites to ensure subject safety in all areas of clinical research, following procedures to report SAEs and UADEs to clinical and regulatory management. Prepare data outputs fwritten and verbal presentations of study data fsymposia, scientific presentations and exhibits, and FDA submissions, as appropriate. Manage the handling of clinical study-related questions from doctors, patients, and sales force, as appropriate. Promote good communication within clinical department, as well as with other Orthofix department members. Collaborate with R&D, marketing, and other departments to ensure alignment with project goals, as appropriate. Contribute to the compilation of FDA submissions as well as the compilation of documents needed fCE-marking. What skills and experience will you need Bachelors Degree in a medical scientific discipline equivalent experience, advanced degree preferred (MS, Ph.D). Significant industry experience in clinical research, 10 + years as a CRA Clinical Project Manager, performing field-based monitoring as required. Demonstrated knowledge of FDA regulations, ICH GCP guidelines and ISO 14155. Subject matter expertise with principles of research design. Excellent decision-making skills. Ability to effectively manage a study from start to finish. Ability to handle challenges and solve unexpected problems. Demonstrated understanding of anatomy, physiology, and medical terminology required. Excellent communication skills required to work effectively with all individuals including the staff at study sites, as well as sales force and professional education. Must work both independently and in a team environment. Proficient computer skills using Microsoft Office products. What skills would be helpful Certification through a professional organization such as ACRP, SOCRA, RAPS. Medical terminology in Orthopedics. Experience with medical device trials including Regulated, Post-Approval and post-market surveillance. What supervisory responsibilities will you have Clinical Research Associates