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Work Schedule

Environmental Conditions

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.

Purpose of the position

+ Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies

+ Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting and tracking

+ Responsible for collecting, tracking and supports reporting of research related Transfer of Value (TOV) to enable compliance with Transparency reporting requirements (US and EU)

+ Responsible for ensuring study documentation (including trial master files, study related contracts and financial level documentation) and study documentation is processed, maintained/archived in compliance with ICH-GCP, Company policy and procedures. Includes liaison with service providers in regard to the e-TMF process and resolving issues related to missing documentation

+ Performing QC checks on TMFs to ensure completeness and readiness for audit/inspection

+ Contributes to clinical trial excellence initiatives

Main responsibilities and tasks:

Be responsible for setting-up, monitoring verifying and archiving the clinical Trial Master File (TMF)

+ In charge of the electronic TMF (and/or paper TMF, if applicable) set-up and administration.

+ Manage the clinical study creation and set-up for the country and site binders and the trial milestones.

+ Prepare and customize the TMF Oversight plan, TMF Management plan, TMF master index & business rules, according to the clinical study specificities with the CRM/CPM and the Document Owners.

+ Inform the appropriate role of all study team members (CRO) newcomers or departure.

+ Ensure the TMF is being maintained up-to-date and all essential documents are appropriately filed in the TMF.

+ Perform continuous oversight of the CRO TMF activities, in checking the documents consistency and the respect of the SOP timelines to maintain the TMF data integrity and by communicating this oversight status to all relevant the study team members.

+ Coordinate the TMF Quality Check (per client SOP) with the CRO to ensure the eTMF inspection readiness.

+ Coordinate the final TMF reconciliation with the CRM/CPM.

+ In charge of archiving the TMF

Be responsible for follow- up and review of financial documents, in collaboration with CRM/CPM

+ Create and update financial information within the financial K2 system (Internal Order, Purchase Order, goods receipt & invoices), if not managed by a dedicated position within the team

+ Create and follow-up of the clinical study Commitment Requests within the dedicated tool (K2)

+ Create and update the specific clinical study budget trackers

+ Review invoices against CRO/Vendor contracts and study progress to provide recommendation of approval or not to the CRM/CPM

+ Follow up of the clinical study invoices to secure payments in time. Support, if necessary, the CRM/CPM in the clinical study budget such as forecast preparation, attendance to quarterly review meetings.

Responsible for tracking, collecting and disclosure of expenses in compliance with regulations in force: EFPIA disclosure code (Europe), Sunshine Act (US)

+ Collect all the information related to reportable transfers of value (ToV) to Healthcare Professionals (HCPs) & Healthcare Organizations (HCOs) in the Group Transparency system (Collect)

+ Ensure the complete data tracking by the CROs with the Data Collection Template (DCT), organize presentation of the instructions to the CROs if needed.

+ Check the data received from the CROs with the support of the CRM/CPM

+ Ensure the information is properly recorded in the COLLECT system, implement corrective actions where needed

+ Ensure the Transfers of value collected (directly or via the CROs) in COLLECT are validated along the way in compliance with the disclosure timings requirements.

+ When needed, create new HCP/HCO records in the COLLECT system

+ Where applicable, check the disclosure consent of Healthcare Professionals (HCPs) for each activity

+ When needed, liaise with the Local Transparency Manager (LTM) or the Global Transparency Manager (GTM) to ensure the mandatory information for HCPs & HCOs is tracked in the Transparency system

Responsible for data entry and status updates within the Clinical Trial Management System (CTMS)

+ When assigned on a study, get access to the study record in eCTMS

+ Check the eCTMS study data using the Clinical Operations Reporting (i.e. Clinical Operations Dashboard, CSS Monthly Report) and update as applicable (at study/region/site level: status, study sites creation, study team/contacts, recruitment, study milestones tracking) with the support of CRM/CPM for the monthly report purposes

+ Ensure the study team contacts and handovers are properly tracked in eCTMS

+ Provide the excel tracker to the CRO together with instructions to get all the necessary information monthly to feed the eCTMs

+ Update the eCTMS with the CRO tracker information after validation with the CRM/CPM as per the CTMS user guide (at study, region and site level as applicable)

Coordinate and conduct in-house and external clinical operations activities

+ Generate contract templates within the dedicated system (i-CAP), follow-up until the clinical study contracts are signed and secure proper filing and archiving of all fully executed contracts

+ Collect and follow-up of all legal administrative documents such as Power of Attorney (POA), Letter of Authorization (LOA), Confidentiality Disclosure Agreement (CDA), Kbis…

+ Ensure insurance certificate and renewals are being requested prior to the study start-up and during the course of the study

+ Coordinate the dispatch order for the clinical supplies if not managed by a dedicated system such as IVRS, meaning the collection of appropriate documents permitting to obtain import license and release study drugs

+ Set-up and maintain shared study electronic site (SharePoint, box or other tools)

+ Organize appropriate logistics for any Sponsor meetings (invitation/room booking/lunch order...) such as Investigator’s meeting, DRM & TFLs, Steering Committee, …

+ Attend all study team meeting when appropriate and take meeting minutes

+ Perform any clinical study activity delegated by CRM/CPM such as the project management and monitoring of clinical studies, including liaison with monitors, CROs, drug vendors, central laboratories and other vendors

Other missions to the position

+ Be active member of dedicated working groups to achieve clinical operation excellence and harmonization by updating/revamping processes

+ Coordinate the writing of articles related to the clinical study or working groups to be posted in the monthly newsletter

+ Provide support to the medical writer within the Clinical Study Report (CSR) to secure the collection of appropriate appendices such as investigators’ Curriculum Vitae, list of Ethics Committee & List of participating investigators

EHS responsibilities:

+ Comply with applicable EHS regulations and procedures.

+ Participate in the site's EHS performance by reporting risks, malfunctions or improvements

+ Participate in mandatory EHS training

Experience / Qualifications

Experience:

+ Ideal: experience in clinical study environment within CRO or Pharmaceutical company.

+ Minimum: Knowledge of the clinical study environment with a strong theorical or practical administrative organization.

+ Scientific background is an asset.

Qualification:

+ 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 3 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.

Language:

+ English: Strong intermediate level

Key Required Technical Competencies

+ Ability to work in a strong regulated environment within a quality management system (QMS)

+ Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader …)

+ Ability to organize and prioritize

+ Able to produce work in teams and within a multi-disciplinary environment

+ Basic Financial Knowledge- must be able to work with financial tracking tools

+ Knowledge of Pharmaceutical Industry R&D

+ Good knowledge of the Good Clinical Practices (GCP) or other clinical study regulations

Compensation and Benefits

The hourly pay range estimated for this position based in North Carolina is –.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs

+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement

+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

+ Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

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.