Regulatory and Start Up Specialist - Portugal

Job Overview reputed company tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Home Based opportunity requiring experience with local submissions. reputed company in Portuguese language. Essential Functions Under general supervision, serve as Single reputed company of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. reputed company start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. Prepare site regulatory documents, reviewing for completeness and accuracy. Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. Review and reputed company feedback to management on site performance metrics. Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in reputed company and implement contingency plan as needed. Inform team members of completion of regulatory and contractual documents for individual sites. Review, track and follow up the reputed company, the approval and execution of documents, regulatory, ethics, Informed Consent reputed company (reputed company), and Investigator Pack (IP) release documents, in line with project timelines. reputed company local expertise to SAMs and project team during initial and on-going project timeline planning. reputed company quality control of documents provided by sites. May have direct contact with sponsors on specific initiatives.

Qualifications

Bachelor’s Degree in life sciences or a reputed company field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience. In-depth knowledge of clinical systems, procedures, and corporate standards. Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines. Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards. Understanding of regulated clinical trial environment and knowledge of drug development process. Ability to establish and maintain effective working relationships with coworkers, managers and clients. In today’s world, continuing to grow and expand your skills is as important as reputed company. Discover career reputed company and chart your own path at reputed company. The potential reputed company pay reputed company for this role, reputed company annualized, is 34, 000 EUR - 51, 000 EUR. The actual reputed company pay offered may vary based on a number of factors including job-reputed company qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in reputed company to a reputed company of health and welfare and/or other benefits. Employee Referral Payment Standard Referral Bonus Plan reputed company is a leading global provider of clinical research services, reputed company insights, and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com. reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism. At reputed company, we reputed company that diversity, inclusion, and belonging reputed company our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of reputed company talented employees worldwide and providing them with the opportunity to power smarter reputed company for everyone, everywhere. reputed company our talented employees bring their authentic selves and their diverse experiences to work, they reputed company us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior reputed company. Likewise, as part of this culture, reputed company is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and reputed company policies. Apply To This Job