Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).
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.
The PPD FSP Solution:
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.
Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.
Summarized Purpose:
Provides administrative and technical support to the Project Team. Coordinates and facilitates project activities and may serve as a study lead acting as a cross-functional liaison for the project team. Acts as a buddy during onboarding phase and provides training to new staff as needed. Supports departmental and cross-functional initiatives for process improvements/enhancements.
Key responsibilities:
According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.
Provides system support (i.e. GoBalto & eTMF).
Supports RBM activities.
Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
Reviews and supervises local regulatory documents.
Transmits documents to client and centralized IRB/IEC.
Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
Maintains vendor trackers.
Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.
May attend Kick off meeting and take notes when required.
Keys to Success
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. Bachelor's degree preferred.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).
Knowledge, Skills and Abilities:
Ability to work in a team or independently as the need arises
Previous experience working with global projects/studies
Strong interpersonal skills and attention to detail, with proven ability to handle multiple tasks efficiently and optimally
Proven track record to optimally analyze project-specific data/systems to ensure accuracy and efficiency
Strong customer focus
Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
Demonstrated ability to attain and maintain a good solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non[1]clinical/clinical aspects of project implementation, execution and closeout
Excellent English language and grammar skills and proficient local language skills as needed
Good presentation skills
Excellent digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
Ability to successfully complete PPD clinical training program
Self-motivated, positive attitude with effective strong interpersonal skills
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
EEO & Affirmative Action Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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