Safety Admin

Work Schedule
Other

Environmental Conditions
Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond 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 quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Location/Division Specific Information

Safety Administrator's provide contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries and physician assessment of diagnostics.

Discover Impactful Work:

Provides contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries and physician assessment of diagnostics. In collaboration with Safety Specialists and Medical Monitors, liaises and establishes effective relationships with functional team members to accurately manage all incoming safety documentation.

A day in the Life:

• Coordinates the timely review of protocol inquiries, serious and non-serious adverse events, diagnostics and Data Safety Monitoring Board data; tracks all necessary data and generates reports for the client, project team and/or external vendors.
• Represents the PPD DSMB/EAC 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 PPD project team, coordinating all logistical aspects and assisting with facilitation.
• Interfaces with various internal and external parties to implement 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.
• Compiles adjudication dossiers and creates/submits follow-up to investigative sites.
• Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and un-blinded minutes/materials to client portals and distributes to internal and external project teams.
• Manages project specific training and the set-up, maintenance and archival of program files; ensuring PVG remains audit ready.
• Identifies and redacts subject identifiers per local requirements, retrains sites and escalates re-occurrences to PPD Data Privacy.
• Performs data entry into internal/external databases, tracking systems and PPD's budget management system; performs system reconciliations to identify issues which may negatively impact project timelines.
• Oversees expenses and manages translations; ensuring budget parameters are not exceeded.
• Answers incoming hotline calls, coordinates department functions and performs other duties as assigned.
• Supports any specific activities performed by the local office, which cannot be performed from elsewhere.
• Provides training to junior staff.

Keys to Success:

Education

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Experience

• 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).

Knowledge, Skills, Abilities

• 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 simultaneously with strict deadlines
• Strong attention to detail and accuracy with orientation toward careful and meticulous work
• Ability to work in a team or independently, demonstrating initiative to complete assigned tasks with moderate supervision
• 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 PPD/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout

Physical Requirements / Work Environment

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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