Director clinical affairs infectious disease job in scarborough, me at alere, 577172068 _ americasjobexchange. com

The Director of Clinical Affairs, Infectious Disease is responsible for the design, management and oversight of clinical studies from the strategic planning stage through the execution and reporting of study results, for a large portfolio of clinical trials conducted in support of the Infectious Disease (ID) Global Business Unit (GBU). O o data recovery The Director will be located at Alere Scarborough in Scarborough, ME but will be responsible for studies conducted in support of ID products developed and manufactured at all Alere entities globally. Data recovery illustrator The Director is responsible for leading and managing the performance of all clinical trials in all regions of the world, and for assuring the safety and welfare of study subjects, quality of study data, timeliness of deliverables, compliance with regulatory requirements, and adherence to budgets. Database management software The Director will supervise a team of clinical scientists, trial managers, research associates, and other support staff, and manage investigational sites, investigators, external consultants and vendors.

Database normalization example The Director is responsible for reporting clinical study results in support of FDA pre-market approvals (PMA), pre-submissions, 510k submissions, OUS product registrations, reimbursement strategies, post-market studies, internal studies, and feasibility studies as required. Database virtualization The Director must collaborate successfully with GBU and department leaders to ensure program goals and objectives are clearly defined and achieved. Data recovery machine The Director is responsible for preparing and managing department budgets and will report to the Vice President Clinical Affairs located at Alere San Diego in San Diego, CA.

Collaborate with GBU leaders and cross-functional stakeholders from R&D, regulatory affairs, biostatistics, and marketing, and with external investigators to develop clinical strategies, objectives and study designs for validation of new ID products in support of regulatory submissions globally. Data recovery cell phone Direct and manage a clinical team to execute study designs that deliver definitive results on time, on budget and in full compliance with all applicable quality and regulatory requirements. Data recovery wizard free Communicate status, timeline, budget and issues for all studies conducted by the department to relevant GBU leaders and department stakeholders, prepare status dashboards as needed. Pokemon x database Prepare department budgets, manage expenses and revise budget forecasts on regular basis in conjunction with finance partners. Data recovery chicago Work with clinical study managers to negotiate study budgets with investigational sites that are fair to all parties and ensure study objectives will be met. R studio data recovery full version Collaborate with the legal department to develop clinical study agreements with investigational sites that are compliant and protect the interests of the business. Database wiki Work effectively in a culture that emphasizes quality first, a culture that is fast-paced and dynamic, and a culture in which cost containment, management of expenses and operational efficiencies are a strategic imperative. Data recovery freeware Provide comprehensive support of all operational aspects of clinical studies including the review and approval of protocols and study-related documents such as regulatory binders, work instructions, CRF development and completion guidelines, monitoring reports, and clinical study reports, etc. Database clustering Provide leadership and direction to the clinical team and effectively delegate appropriate tasks, assignments, and responsibilities. Icare data recovery Develop goals and objectives for department members consistent with over-arching corporate goals and strategic imperatives. Data recovery jacksonville fl Provide feedback and evaluate performance on regular basis. 510 k database search Prepare and manage department merit budget. Database engineer Provide appropriate training for team members to ensure consistent execution of all study related activities and opportunities for professional growth. Data recovery california Have good knowledge of and experience with Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) guidelines for Good Clinical Practices (GCPs). Moto x data recovery Ensure clinical standard operating procedures (SOPs) are in full compliance with GCPs and all related quality and regulatory requirements. Database administrator Ensure all studies are conducted in full compliance with GCPs and company SOPs. Database acid Have good knowledge of and experience with the requirements of FDA and regulatory bodies outside the US for clinical validation of in vitro diagnostic (IVD) products. Database 10g Participate in Clinical Research Organization (CRO) selection process for outsourced activities as applicable. Database news Direct and oversee CRO activities including study management, site monitoring, data management and study master files as applicable. Database key value Work with clinical data management group to ensure CRF design, CRF completion, resolution of queries, and database lock activities are completed in accordance with all applicable quality standards and timelines. Data recovery pro review Travel is expected to be 10-20%. Data recovery windows 8 Travel to sites for study initiation, training and assessment of research study team activities may be necessary at times. Data recovery devices Travel to Alere San Diego or other Alere companies will be necessary at times. Moto g data recovery software Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companys policies and practices. Data recovery windows 10 Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Database youtube Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

Preferred educational background: BS/BA degree in biomedical science or related area with at least 8-10 year experience in clinical research or related area, preferably in IVD industry. H2 database console MS or PhD degree preferred.

Preferred experiential background: Clinical trial management experience with demonstrated ability to manage and deliver results for a large portfolio of complex clinical studies. Database browser Knowledge and experience working with assays and platforms designed for detection of infectious disease agents in various samples types. Database help Knowledge and experience with assays and platforms that detect antigens (viral and bacterial) and antibodies using immunoassay and molecular diagnostic technologies. Database vendors Knowledge and experience with FDA requirements for clinical validation of infectious disease assays using point-of-care systems for 510k clearance and CLIA waiver. Database key Experience with and in-depth knowledge of FDA, ICH and GCP requirements for conducting clinical studies. Data recovery live cd Knowledge and experience in developing and maintaining department SOPs. Data recovery clean room Strong management skills with proven leadership and team building skills. Database view Excellent oral and written communication skills. Data recovery fort lauderdale Good working knowledge of clinical data management and statistics, and strong computer skills using Microsoft Excel, Word, and Outlook. Data recovery equipment tools Ability to work within established timelines, in a fast paced environment. Data recovery lab Excellent organizational and priority management skills. Data recovery online Good interpersonal skills and ability to interact with people at all levels and within all departments of the company.