COUNTRY SENIOR STUDY ANALYST

Position code: 3716 Position Title: COUNTRY SENIOR STUDY ANALYST



Work Location: New Jersey - Nutley Corporate Headquarters



Major Responsibilities:

The CCOA is a member of the Affiliate division and is responsible/accountable for supporting the daily Clinical Operations functions for a study or series of studies within a project. The CCOA is an active member of the Local Study Implementation Team (LSIT) which is led by the Country Study Manager (CSM). The CCOA applies knowledge of clinical development processes to support the CSM, the LSIT, and the business needs of the US. The CCOA works in conjunction with the Field Clinical Trial Monitors (monitors) to manage and oversee study sites.

Principal Responsibilities

General:

? Provide CSM/LSIT with regular status updates.

? Liaise with local marketing and business affiliate by establishing relationships which foster communication, shared knowledge and skills and provide customers with consistent support from both the Development and Business organizations.

? Participate as a full member of the LSIT

? Liaise with Roche/CRO monitors within US to ensure consistent conduct of study across sites.

? Liaise with other departments within Roche (e.g., data management, clinical science) for the duration of a study(s).

? Provide direction and mentoring to Research Project Assistants/Clinical Operations Coordinators (RPAs/COCs), and support staff, as appropriate.

? May participate in the interview process for team members as appropriate.

? May act as back-up to the CSM.



Study Start-Up:

? Provide and collate information for the LSIT regarding US issues relative to protocol development.

? Assist in the development, collection and collation of data for feasibility testing within the US.

? Provide guidelines to monitors and investigators regarding US IND requirements.

? Oversee the contents of US regulatory file of ICH essential documents, and the management of the flow of required documents to the appropriate archives, and regularly liaise with archive staff as needed.

? Assist the CSM in developing the US study budget including- determining US resource requirements for the study(s).

? Assist in the selection of US external service providers (e.g., central laboratories, CRO?-s, courier companies, and randomization organizations), and assist in the management, development, review, negotiation, and maintenance of contracts.

? Assist the CSM in determining US drug requirements.

? Assist in the management of US study drug ordering, packing and shipping processes, and review and finalize drug labels for the US.

? Assist in the evaluation and assessment of US sites with the monitors or CRO and the CSM based on defined site selection criteria.

? Provide input regarding local issues and practice related to data collection requirements for CRF-s.

? Review draft CRF?- s and assist in finalization and subsequent annotation for training purposes within the US.

? Assist in the identification of US issues regarding study conduct for inclusion in the Study Specific Procedures Manuel (SSPM) and assist in development of the SSPM

? Assist in the coordination of all aspects of local investigator and monitor meetings and workshops including developing agendas, preparing materials, coordinating presentations, and identifying, resolving, and communicating follow-up issues. May make presentations at these meetings.

? In conjunction with the CSM, assess Source Document Verification (SDV) requirements related to monitoring resource needs and availability for the US.

? Develop local budget from PICAS and modify global study budget template for local use. Assist monitors with budget issues/negotiations as needed to ensure consistency among sites.

? Provide US tracking tools as needed (e.g., monitoring tools).



Study Implementation and Conduct:

? Coordinate activities for LSIT with central laboratories, randomization organizations, and other external service providers (e.g., courier companies).

? Oversee the management of tracking systems for LSIT related to drug supply and use, enrollment of subjects, regulatory document flow, study timelines, financial information, Serious Adverse Events, AIMS, data flow, etc.

? Assist in the management of US central labs for LSIT related to budget/contract specifications and negotiations, quality assurance, and invoice review and payments.

? Assist in the management of US CROs related to budget/contract specifications and negotiations, performance related to defined scope of work, timelines and quality, adherence to study criteria, invoice review and payment reconciliation.

? May assist in the review of monitoring reports to identify trends/issues within the US requiring local intervention.

? Develop and distribute study newsletters to US monitors and sites.

? Manage central repository for frequently asked questions from US monitors and sites if needed.

? Manage local drug ordering, shipping, retest/expiry, destruction/return and tracking.

? Manage data flow process in conjunction with monitors related to data review, query resolution and CRF collection and retrieval.

? Monitor and track SAEs for the US. Manage the processing of SAE information received from investigators including review, clarification, and interactions with monitors, sites, Drug Safety, and Clinical Science.

? Assist with US study budget reconciliation and forecasting using Roche standard planning and tracking tools.

? Review audit plans and reports and assist in resolution of US issues identified by PDQ (Quality Assurance).

Study Close-Down:

? Coordinate the US site close down activities with the monitors related to outstanding site issues, return of drug/equipment/supplies, and scheduling of close-out visits.

? Manage review of US essential documents in archives as required to ensure archives are complete.

? With CSM and LSIT, assist with activities related to closure of database.

? Provide US operational input into final study report as required.

Qualifications:

Bachelor?s degree, preferably in science, nursing, other biomedical discipline, or equivalent.

Experience

Training in biomedical field or relevant experience in a clinical trial environment preferred.