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.

Division Specific Information

Our global Clinical Research Group (CRG) colleagues within the Functional Service Partnership (FSP) solutions area provide support for clinical trials during feasibility, study start up, maintenance, close out, and database lock, depending on the client’s needs. Client-dedicated Clinical Trial Coordinators (FSP CTCs) work directly with clients to provide administrative and technical support by performing day-to-day functions within the client organization to support clinical trial activities.

In the FSP CTC role, you will represent PPD, part of Thermo Fisher Scientific, while working alongside the client, as a partner, providing a specific service. Tasks can include providing administrative and technical support to the client study team; supporting client audit readiness by ensuring client systems are accurate and up to date; providing administrative support for site activation activities; and managing assigned service providers and/or vendors. FSP CTC roles and responsibilities may vary based on client needs.

What You'll Do:

• 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. Go Balto & 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 tracks 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.

REQUIREMENTS:

Education and Experience Requirements:

• 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). 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 and Abilities:

• Ability to work in a team or independently as required

• Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively

• Proven ability to effectively 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 working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non- 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 computer skills, 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

Working Conditions and Environment:

• Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.

• Occasional drives to site locations. Potential Occasional travel required