Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model. The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality. • Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies • Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations. • Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality. • Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks. • Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations. • Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head. • Ensures timely preparation of local Master CSA (including site budget) and amendments as needed. • Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations. • Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs. • Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction). • Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations. • Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans. • Reviews monitoring visit reports (as required and following SOPs) and pro-actively advices the monitor(s) on study related matters. • Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs. • Proactively identifies risks and facilitates resolution of complex study problems and issues. • Organises regular Local Study Team meetings on an agenda driven basis. • Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders. • Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead. • Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary. • Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed. • Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable. • Plans and leads National Investigator meetings, in line with local codes, as required. • Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies. • Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at country level. • Ensures accurate payments related to the study are performed according to local regulations and agreements. • Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and Procedural Documents. • Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline manner to maintain the eTMF “Inspection Ready”. • Ensures that all study documents are ready for final archiving and completion of local part of the eTMF. • Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA. • Provides input to process development and improvement. • Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues. • Updates Line Managers about the performance of the CRAs/CSAs. • Ensures that study activities at country level comply with local policies and code of ethics. • Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. • Ensures compliance with Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment). • Collaborates with local Medical Affairs team. • Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management. TU preference: Oncology Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. 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. 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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