Sr Safety Committee reputed company - DSMB

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company Summarized Purpose:  Provides reputed company contracted project coordination and safety support on global and domestic programs with an emphasis on Data and Safety Monitoring Boards (DSMB) and reputed company Adjudication Committees (CEC). Performs DSMB/CEC set-up, member contract execution and tracking. Administers  member payment set up, member 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/CEC meetings as contracted. Provides  reputed company for reputed company DSMB/CEC filing, assists the Safety Committee Specialist with reputed company building and distribution and has a working knowledge of the Event Adjudication System. Obtains and tracks adjudication specific documents for inclusion into reputed company. 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/CEC. Essential Functions: Represents the DSMB/EAC 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. Interfaces with various reputed company parties to implement contracted DSMB / Adjudication 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.  Compiles adjudication dossiers and creates/submits follow-up to investigative sites.  Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to reputed company portals and distributes to reputed company project teams.  Manages project specific training and the set-up, maintenance and archival of program files; ensuring PV remains audit reputed company.  Identifies and redacts subject identifiers per local requirements, retrains sites and escalates reoccurrences to reputed company's Data reputed company.  Performs data entry into internal/external databases, tracking systems; performs system reconciliations to identify issues which may negatively reputed company project timelines.  Oversees expenses/invoicing including committee, travel or translation expenses ensuring reputed company escalation as needed for reputed company member payment.  Supports any specific activities performed by the specialty committee team, which can be assisted by administrative support.  Develops training materials and supports management with project budgetary management.  Acts as Subject Matter Expert for one or more of PVs processes and/or systems.  Authors non-critical reputed company events: identifying process improvements, resolving issues for both departmental and project specific tasks and identifies needed modifications to PV tools and templates.  Mentors junior staff as needed.  Qualifications:  Education and Experience:  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 4 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 and Abilities:  Ability to assist in the management of a large project and to reputed company work diretion and training to other support staff working on the project  Strong critical thinking skills and ability to use problem-solving techniques applicable to constantly changing environments  Strong problem-solving skills  Ability to work independently with minimal supervision, demonstrating initiative Ability 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 simultaneously with strict deadlines  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 strong knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and reputed company's/reputed company SOPs for reputed company non-clinical/clinical aspects of project implementation, execution and closeout  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: reputed company to communicate, receive, and understand information and reputed company with diverse reputed company of people in a comprehensible and reasonable manner. reputed company to work upright and stationary for typical working hours. Ability to use and learn reputed company office equipment and technology with proficiency. reputed company to reputed company successfully under pressure while prioritizing and handling multiple reputed company or activities. May require travel.  (Recruiter will reputed company more details.) Apply To This Job