Regulatory and Start Up Specialist 2 - Egypt

دوام كامل في Saudi Petroleum Services Polytechnic في Saudi Arabia

نُشرت يوم December 24, 2024

تفاصيل الوظيفة

Discover a career with greater purpose Start right here. Regulatory and Start Up Specialist 2 - Egypt Egypt Full time R1458516 Riyadh, Saudi Arabia| Tunisia| Egypt| Remote Job Description Job Overview Perform 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. The role requires experience as RSU within Saudi, Tunisia and Egypt. Arabic fluency is required. Essential Functions Under general supervision, serve as Single Point 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. Perform 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 provide feedback to management on site performance metrics. Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place 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 progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines. Provide local expertise to SAMs and project team during initial and on-going project timeline planning. Perform 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 related 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. Good negotiating and communication skills with ability to challenge, if applicable. Effective communication, organizational, and interpersonal skills. Ability to work independently and to effectively prioritize tasks. Ability to manage multiple projects. 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.

#J-18808-Ljbffr

Apply safely

To stay safe in your job search, information on common scams and to get free expert advice, we recommend that you visit SAFERjobs, a non-profit, joint industry and law enforcement organization working to combat job scams.

R&d Portfolio Mapping And Value Creation Specialist

Saudi Aramco (ASC)

... . Overview We are seeking a R&D Portfolio Mapping and Value Creation Specialist to join our Technology Strategy ...