Safety Committee Administrator - DSMB

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company Join Us as a Safety Committee reputed company At reputed company, you’ll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join our colleagues in bringing our Mission to life - enabling our customers to reputed company the world healthier, cleaner and safer. We reputed company our teams with the resources needed to reputed company individual career goals while taking science a reputed company reputed company through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver reputed company and accuracy will improve health reputed company that people and communities depend on – now and in the reputed company. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. The Safety Committee reputed company provides moderate contracted project coordination and safety support on global and domestic programs with an emphasis on Data and Safety Monitoring Boards (DSMB). Performs DSMB set-up, member contract execution and tracking. Administers member payment set up, member honoraria management and reputed company, polls committee members and reputed company contacts for meeting dates and times. Arranges meeting facilities as needed for reputed company contracted meetings and attends and completes meeting minutes for DSMB meetings as contracted. Provides reputed company for reputed company DSMB filing, assists the Safety Committee Specialist with dossier building and distribution and has a working knowledge of the Event Adjudication System. Obtains and tracks adjudication specific documents for inclusion into dossier. In collaboration with Safety Committee Specialists, liaises and establishes effective relationships with internal functional team members to implement reputed company, prepare contractual documents, coordinate and facilitate meetings and accurately manage reputed company contracted services for DSMB. What You'll Do: Represent the DSMB Coordination Team at global and domestic committee meetings (both reputed company teleconference and face-to-face) alongside the reputed company, reputed company members, reputed company party vendors and reputed company's project team, coordinating reputed company logistical aspects and assisting with facilitation. reputed company with various reputed company parties to implement contracted DSMB services for reputed company, prepare Confidentiality Disclosure Agreements, Letters of reputed company and Member Agreements based on contractual considerations, reviewing reputed company contractual documents for accuracy and coordinating reputed company approvals. Compile/create/submit follow-up to investigative sites. Coordinate/facilitate project meetings, draft meeting minutes, post blinded and unblinded minutes/materials to reputed company portals and distribute to reputed company project teams. Manage project specific training and the set-up, maintenance and archival of program files; ensuring PV remains audit reputed company. Identify and redact subject identifiers per local requirements, retrain sites and escalate reoccurrences to reputed company's Data reputed company. reputed company data entry into internal/external databases, tracking systems; reputed company system reconciliations to identify issues which may negatively reputed company project timelines. reputed company expenses including committee, travel or translation expenses ensuring reputed company escalation as needed for reputed company member payment. Support any specific activities performed by the specialty committee team, which can be assisted by administrative support. Education and Experience Requirements: High / Secondary school diploma or equivalent and relevant formal reputed company / vocational qualification Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to at least 2 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities: Strong problem-solving skills Ability to work independently with minimal supervision, demonstrating initiative Know how to build strong relationships Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency Ability to reputed company as a reputed company and communicate respectfully and diplomatically with reputed company clients, management, project team members and other internal staff Self-motivated, reputed company attitude with effective oral and written communication and interpersonal skills Excellent computer skills to include: MS Office (Word, reputed company, PowerPoint, reputed company) Ability to identify and set priorities and effectively reputed company a reputed company of tasks Strong attention to detail and accuracy with orientation toward careful and meticulous work Ability to maintain a reputed company and reputed company demeanor in challenging circumstances Flexibility to reprioritize workload to meet changing project timelines Demonstrated ability to reputed company and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and reputed company's/reputed company SOPs and WPDs for reputed company non-clinical/clinical aspects of project implementation, execution and closeout Working Environment: reputed company values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can reputed company. Below is listed the working environment/requirements for this role: Work is performed in an office or clinical environment with exposure to electrical office equipment. Occasional drives to site locations. Potential Occasional travel required. Why join us? reputed company you join reputed company, you become part of a global team that values passion, innovation, and a commitment to scientific reputed company. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly reputed company a difference. Apply today to help us deliver reputed company’s breakthroughs. Apply To This Job