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.

Summarized Purpose:
Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents CRG personnel. May utilize local knowledge, organization systems, external site lists and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process.

Key responsibilities
According to the specific role (Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
Ensures allocated tasks are performed on time, within budget and to a high1quality standard. Proactively communicates any risks to project leads.
Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
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, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
May support scheduling of client and/or internal meetings.
May review and track of local regulatory documents.
May provide system support (i.e., Activate & eTMF). May support RBM activities.
May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and tracking of project level activity plans in appropriate system(s).
Transmits documents to client and centralized IRB/IEC.
Maintains vendor trackers.
Provides support as needed to coordinate with internal departments, ensuring site start-tup activities within the site activation critical path are aligned.
Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
Ensures an efficient, effective plan is in place for site contact and follow up.
Ensure compliance with the plan and escalate concerns/non-compliance to management.
Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information.

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 1-2 years).

Knowledge, Skills and Abilities:
Ability to work in a team or independently as required
Good organizational skills and strong attention to detail, with proven track record to handle multiple tasks efficiently and effectively
Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
Strong customer focus
Flexibility to reprioritize workload 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-clinical/clinical aspects of project implementation, execution and closeout
Good English language and grammar skills and proficient local language skills as needed
Good 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 the organizations clinical training program
Self-motivated, positive attitude and good interpersonal skills
Effective oral and written communication skills
Good interpersonal skills
Crucial judgment and decision-making skills
Capable of accurately following project work instructions
Good negotiation skills
Entrepreneurial thinker
Ability to manage risk and perform risk escalation appropriately

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. #Start Your Story with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.