Regulatory & Start-Up Lead

Job Advertised by Pharmadiversity Job Board - Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. Position is office based in Research Triangle Park, NC. RESPONSIBILITIES Specific responsibilities vary across individual positions. Typical responsibilities of this job classification include the following: *Serve as Site Start-Up lead within a country or region for projects or service line. Lead SSU team or service line members in all designated activities. Monitor team efficiency and adherence to project timelines. Ensure adherence to standard operating procedures (SOPs) and work instructions (WIs) and quality of designated deliverables. *Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy. *Review and provide feedback to management on site performance metrics. *Work with sponsors and internal team members to establish regulatory requirements and contracts necessary for startup. Review and negotiate regulatory documents, contracts, and contract amendments with sites and sponsors for agreement on wording and budgets. Ensure accuracy and completeness of documents. *Serve as central contact for investigative sites, designated project reports, and customer service. *Resolve site issues and determine status for product shipment. *Work with regulatory team members or sponsor to secure authorization of regulatory documents. *Work with legal team members or sponsor to secure authorization of contracts. *Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables. *Where applicable, provide work instructions to team members in preparation of regulatory submissions. *May translate or review completed translations of critical documents. *May participate in feasibility and/or site identification activities. MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelor's Degree in a related field and 3 years clinical experience; or equivalent combination of education, training and experience REQUIRED KNOWLEDGE, SKILLS AND ABILITIES *In-depth knowledge of clinical systems, procedures, and corporate standards *Strong knowledge of medical terminology and regulations *Broad knowledge of clinical research *Strong knowledge of Microsoft Office and e-mail applications *Effective communication, organizational, and interpersonal skills *Ability to work independently and to effectively prioritize tasks *Ability to delegate effectively *Ability to manage multiple projects *Attention to detail *Ability to establish and maintain.... br/ br/ * For application attention if web source is requested please use PharmaDiversity or PharmaDiversity Job Board. br/ br/ APPLY FOR THIS JOB by going to ...http://www.pharmadiversityjobboard.com/view_job.php?post_id=577647&tag=aje