Title: Safety Committee Administrator - DSMB Location: Remote North Carolina United States of America Full tie Remote   Join Us as a Safety Committee Admin The Safety Committee Admin 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 oversight, polls committee members and client contacts for meeting dates and times. Arranges meeting facilities as needed for all contracted meetings and attends and completes meeting minutes for DSMB meetings as contracted. Provides oversight for all 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 projects, prepare contractual documents, coordinate and facilitate meetings and accurately manage all contracted services for DSMB. What You'll Do: - Represent the DSMB Coordination Team at global and domestic committee meetings (both via teleconference and face-to-face) alongside the client, board members, third party vendors and the company's project team, coordinating all logistical aspects and assisting with facilitation. - Interface with various internal and external parties to implement contracted DSMB services for projects, prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations, reviewing all contractual documents for accuracy and coordinating internal and external approvals. - Compile/create/submit follow-up to investigative sites. - Coordinate/facilitate project meetings, draft meeting minutes, post blinded and unblinded minutes/materials to client portals and distribute to internal and external project teams. - Manage project specific training and the set-up, maintenance and archival of program files; ensuring PV remains audit ready. - Identify and redact subject identifiers per local requirements, retrain sites and escalate reoccurrences to the company's Data Privacy. - Perform data entry into internal/external databases, tracking systems; perform system reconciliations to identify issues which may negatively impact project timelines. - Oversee expenses including committee, travel or translation expenses ensuring proper escalation as needed for timely 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 academic / vocational qualification - Technical positions may require a certificate - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).   In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related 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 act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members and other internal staff - Self-motivated, positive attitude with effective oral and written communication and interpersonal skills - Excellent computer skills to include: MS Office (Word, Excel, PowerPoint, Access) - Ability to identify and set priorities and effectively perform a variety of tasks - Strong attention to detail and accuracy with orientation toward careful and meticulous work - Ability to maintain a positive and professional demeanor in challenging circumstances - Flexibility to reprioritize workload to meet changing project timelines - Demonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and the company's/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout

Title: Clinical Auditing Specialist II - Vendor and Information System Audits Team - Remote, United Kingdom - Remote, Romania - Remote, Serbia - Remote, Czechia - Remote, Bulgaria - Remote, Hungary - Remote, Belgium - Remote, Poland Full time   Join us as Quality Assurance Auditor II (Technology Solution Audits Team) and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.   What You’ll Do: - Conduct and/or lead external supplier GxP information systems audits as requested by senior management, including but not limited to on-site, virtual, questionnaire, or desktop audits of technology solutions used in clinical trials - Assess processes related to computerized systems used in clinical trials, including Quality Management Systems (QMS), System Development Life Cycle (SDLC), information security, data integrity, business continuity, disaster recovery, backup and restore, and data center and/or cloud hosting environments. - Provide GxP regulatory consultation and support to internal project teams and stakeholders on information systems compliance requirements, including but not limited to 21 CFR Part 11 and applicable EMA guidelines for computerized systems used in clinical trials. - Prepare, document, and issue audit reports and observations to departmental and cross-functional stakeholders - Contribute to team’s Practical Process Improvement (PPI) efforts   Required Education and Experience: - Bachelor's degree or equivalent and relevant formal academic / vocational qualification - Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).   Required Knowledge, Skills and Abilities: - Thorough knowledge of GxP and appropriate regional research regulations and guidelines - Demonstrated proficiency and led a range of GxP audits to high standards required by management - Working knowledge or familiarity with GAMP 5 R2, computer system validation concepts, 21CFR Part 11 Compliance, and the software development lifecycle (SDLC). - Excellent oral and written communication skills - Strong problem solving, risk assessment and impact analysis abilities - Solid experience in root cause analysis - Above average negotiation and conflict management skills - Flexible and able to multi-task and prioritize competing demands/work load - Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

• Manage inbound client enquiries across multiple channels • Develop strong knowledge of services to support client conversations • Accurately record and manage client data in CRM systems • Support existing clients with additional needs • Build and nurture strong client relationships • Coordinate with internal teams to ensure seamless service delivery • Contribute to projects improving customer experience and conversions

• Serve as the primary point of contact for major client accounts, ensuring compliance and client satisfaction • Manage complex contract amendments and colocation requests, including risk assessment and resolution of issues • Lead preparation of detailed and executive-level reports, providing insights and recommendations for decision-making • Oversee FCU and RFI processes, ensuring timely and accurate execution across multiple regions • Identify trends, risks, and opportunities for improvement in operational workflows and recommend strategic solutions • Coordinate with internal and regional teams to resolve escalated issues and ensure seamless execution of processes • Mentor and guide junior administrators, providing training and best practices for account management • Collaborate with senior leadership on strategic initiatives related to resource sharing and infrastructure optimization