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Sr. Regulatory Affairs Specialist

Company: Kelly Global Talent Solution
Location: Madison
Posted on: February 15, 2020

Job Description:

Senior Global Clinical Operations Manager?A Senior Global Clinical Operations Manager plays an essential role in the development and implementation of global clinical studies by providing significant tactical management for assigned projects and contributes to development and implementation of operational strategies and clinical trial designs.Responsibilities include the planning, execution, and interpretation of global clinical trials and ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registrations and commercialization of company products.?ESSENTIAL DUTIES AND KEY DELIVERABLES: Contributes substantially to strategic discussions regarding the design of global clinical programs and in reporting the progress of clinical programs by working collaboratively with the study management team (SMT) members. Negotiates and is responsible for clinical operations study timelines during project development and manages clinical operation activities to meet enrollment targets according to the projected timeline. Develop site level budget and participate in discussion for near and longer-term program level forecasting and ensures studies are managed within approved budget guidelines. Contributes to development of RFPs and participate in selection of CROs/vendors. Recommends resource requirements for assigned projects. Oversees global clinical operations activities for assigned projects, including but not limited to, the following: Preparation/procurement of all manner of documents and supplies related to the clinical trial process (e.g. Investigator?s Brochure, Protocols, Case Report Forms, Informed Consent Documents, etc.). Assist with the development of the clinical sections for submissions to regulatory bodies (e.g. FDA, EMA, etc.) and IRBs/ECs (e.g. INDs, NDAs, Annual Reports, Pre-meeting Packages, Clinical Study Reports, etc.) for assigned project(s). Clinical Operations activities to evaluate and select sites, vendors (e.g. IXRS, lab, reading centers), consultants, CROs, etc. for assigned studies. Oversees monitoring and management of clinical studies to assure they are conducted in compliance with the protocol, Standard Operating Procedures, Good Clinical Practice and appropriate regulatory requirements. Oversees and/or manages Global Clinical Operations activities collaborating with Clinical Science, Biometrics, Drug Safety and other departments to coordinate the review, evaluation, quality, validation and reporting of moderate to complex clinical data. Facilitate and Lead SMT for assigned projects as requested. Prepares and/or presents written and oral presentations regarding clinical trial progress/results to SMT. Participate in clinical development initiative such as clinical standard operating procedures committee, eTMF committee, Data Management Core Team etc.? Provides training and Mentor clinical study managers and more junior level clinical operations colleagues. Maintains up to date extensive knowledge and understanding of Good Clinical Practices, regulations and guidance documents and industry trends/best practices. Develops and maintains close working contacts with other functional areas outside of GCOe.g. Regulatory, Pharmaceutical Development, Business Development and Strategic Marketing, Finance, etc. to facilitate clinical trials research. Develops and maintains relationships with key opinion leaders (KOLs) and clinical scientists to support development activities on a global basis.QUALIFICATIONS: Core competencies, education, and experience. At least Fiv or more (5+) years of clinical research experience with a BSc degree in a relevant scientific discipline (Ophthalmology experience would be advantageous) and relevant clinical operation experience in the pharmaceutical industry or equivalent. . Experience in managing staff? (i.e., CRAs, consultants, etc.) and vendor management strongly preferred. Significant experience in the oversight of day-to-day clinical operational aspects of drug development. Must have the ability to make high level decisions and work effectively within a team. Strong verbal communication and scientific writing skills (i.e., protocol development, ICF development, site level documents etc), and good interpersonal/group skills. Must be able to communicate information between regions and with senior level management both inside and outside of company. Must demonstrate tact and the ability to positively influence others across all organizational functions and levels. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations Significant knowledge of FDA and ICH regulatory requirements e.g. Guidance, guidelines, CFR, etc. and implementation guidelines. High degree of computer proficiency, preferably in MS Office environment. Highly detail oriented. Adaptable to changing regulatory environments. Flexible team player with the ability to work in a changing environment. Demonstrated track record of driving projects/deliverables to completion within established deadlines. Must exercise good judgment regarding routine and non-routine assignments. With minimal input from management, must be able to set and prioritize goals and objectives for self and Global Clinical Operation team members; excellent time management and organizational skills. Proven ability to manage teams. Ability to work collaboratively and effectively with people from cultural diversity? (e.g., Europeans, Japanese); previous work experience with Japanese companies a plus. ?Why Kelly??With Kelly, you?ll have access to some of the world?s highest regarded scientific organizations?providing you with opportunities to work on today?s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you?ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career?connect with us today.About Kelly?At Kelly, we?re always thinking about what?s next and advising job seekers on new ways of working to reach their full potential. In fact, we?re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Keywords: Kelly Global Talent Solution, Madison , Sr. Regulatory Affairs Specialist, Other , Madison, Wisconsin

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