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.

　　Responsibilities :

　　According to the specific role (Central or 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 highquality

　　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.

　　· Analyzes and reconciles study metrics and findings reports. Assists with

　　clarification and resolution of findings related to site documentation.

　　· 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.

　　· Maintains knowledge of and understands SOPs, client SOPs/directives, and

　　current regulatory guidelines as applicable to services provided.

　　· Where applicable, conducts on-site feasibility visits (Asia Pac only).

　　· 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.

　　· Supports start-up team in Regulatory submissions.

　　· Works directly with sites to obtain documents related to site selection.

　　Assists the project team with the preparation of regulatory compliance review

　　packages.

　　· Provides support as needed to coordinate with internal departments, ensuring

　　site start-tup activities within the site activation critical path are aligned.

　　· May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of

　　associated documents from investigators and site personnel.

　　· Documents in real time all communication, attempts an follow up associated

　　with site contact and survey responses.

　　· Supports the review of survey data to ensure responses are logical, complete

　　and reflective of the question asked.

　　· Works in collaboration with teammates to achieve targeted deadlines for

　　assigned projects. Communicate 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.

　　· May act as the local expert regarding site capacity and experience. Work with

　　key local personnel to gather knowledge base and recommend additional sites.

　　Harness this knowledge base when performing local tiering of sites.

　　· Liaises with Global Investigator Services to resolve investigator queries in real

　　time and maintain ‘accounts and contact’ information.

　　· Contributes to the development and roll-out of global strategic feasibility

　　processes and best practices.

　　· Trains new personnel in processes and systems.

　　· Utilizes local knowledge to contribute to the identification and development of

　　new sites.

　　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.

　　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.