Clinical Documentation Associate III
Thermo Fisher Scientific

Job Info

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Work Schedule
Standard (Mon-Fri)

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.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Discover Impactful Work:

Delivers extensive global records management (GRM) and file room support by working closely with global project teams to ensure all global records management tasks are completed according to organization and/or client standard operating procedures (SOP) and working practice documents (WPD) and provides in-depth technical assistance to study teams.

A day in the Life:

• Processes (scans/images, indexes, files) incoming study documents.
• Coordinates support for clincical study teams as required per WPD/SOP with filing of all documents for the trial master file (TMF/eTMF) and case report forms (CRFs).
• Serves as the study team subject matter expert on filing process for assigned studies.
• Liaises with the clinical study team to resolve outstanding issues identified during filing and/or quality reviews.
• Provides extensive technical support for the study team when initiating the TMF.
• Develops, maintains, and updates products and systems associated with global records classification, retention, and disposition.
• Develops, and/or conducts training for department staff, company employees, and clients.
• Provides oversight and support for entry level team members.
• Assists with applicable sponsor deliverables data collection to confirm departmental metrics.
• Coordinates special projects.
• Maintains and updates existing capabilities and information to ensure the continued development and maintenance of the department.

Keys to Success:

Education

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Technical positions may require a certificate

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 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

• Advanced communication and interpersonal skills
• Proven organizational skills and strong attention to detail with proven ability to handle multiple tasks efficiently and effectively
• Advanced ability to effectively analyze project data/systems to ensure accuracy and efficiency
• Flexibility to reprioritize workload to meet changing project timelines
• Excellent computer skills
• Excellent English and grammar skills, (second language a plus)
• Firm understanding of applicable systems, such as document management and the eTMF

Work Environment

Thermo Fisher Scientific 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 and/or standing for typical working hours.
• Able 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.

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.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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