On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD. Together, Thermo Fisher and PPD share the pursuit of a common goal: to enable customers to make the world healthier by accelerating the development of new medicine

• Collaborates with multiple team members in a matrix environment for the effective delivery of site activation within the assigned projects.• May oversee site activation for assigned projects according to timelines and quality standard.• Assists with coordination of the flow of information between PPD teams, clients, or functional departments involved in site activation.• Develops recommended plans/guidelines for project implementation using PPD tools• Monitors and analyzes project status to ensure successful progress and completion of all assigned projects and provide metrics to upper management.• Performs risk identification and provides contingency planning.• Collaborates with PPD teams to manage all financial and contractual aspects of the studies related to site activation.• Works within the team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets with accountability to Global Project Management.• Administers the technical and operational aspects of the site activation portion of the assigned projects, including coordination of feasibility, site contracts, and country teams in a matrix environment and manages the assigned scope of work against timelines, costs, and quality.• Participates with functional area leads to identify and evaluate fundamental issues pertaining to successful site activation, interpret data on complex issues, make good business decisions and ensure solutions are implemented.• Develops customer relationships in alignment with assigned projects.

Scope: Europe and Israel Type of clinical trials: Medical DevicesOperational responsibilites: Managing Regulatory and Ethics Commitees sumbissions from strart-up through maintenance amd study end for 3 large (10+ countries) Medical Device studies.Line managment responsibilities: Managing 3 direct reports

Scope: EMEA, APAC, LATAM, MENA, USAOverview: Acts as an Site Start-up Lead for studies in maintenance phase for assigned projects.- Provides oversight of all project SSU activities which encompasses all activities for life cycle maintenance amendment deliverables.- Collaborates with all major functional area leads including (SSU Country Managers, Project Management, Clinical, Data Management, and Medical Writing).- Develops and maintains relationships with customers in alignment with their assigned projects. Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed.- Communication and coordination with country start-up specialists for all RA, IEC/IRB submission deliverables and with Site Contract Negotiator(s) for amendments to contracts and/or budget independent to the submission deliverables.- In collaboration with the Project Lead (PL), reconciles revenue units completed and forecasts future units on a monthly basis.- Uses corporate tools for planning and management of scope, timeline, and resources and ensures minimum hours are used for tasks. If out-of-scope work is requested, notifies the Project Lead (PL) and tracks out-of-scope work.- Prepares the core submission documents and core clinical trial application dossier and obtains agreement from the Sponsor on package contents.- Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation, gaps and highlights and obtains 2nd level review from a more senior team member.

Scope: Republic of Serbia, Republic of Macedonia, Bosnia and Herzegovina, Georgia- Identify nature and scope of the ethics and regulatory submissions services, including safety reporting as applicable, being contracted from the Sponsor/Client for submission of clinical studies- Customization of country specific Informed Consent Forms (ICFs);- Management of the ethcis, regulatory and safety submissions of the assigned studies in accordance with the applicable law and regulations, as well as SOPs, and current GCP;- Ensure the proper completion of all necessary applications, registration, certification, and/or other documents that are to be included in the ethics and/or regulatory submission;