Regional Clinical Trial Management Associate

General Description:

• Supports the Regional Clinical Study Manager in regional study delivery and ensures that delegated components of clinical studies are executed per expected and specified quality standards, within timelines and budget.

• Supports the Clinical Research Associates and/or Study Start-up Specialists in country study delivery and ensures that delegated components of clinical studies are executed per expected and specified quality standards.

• Builds solid knowledge of clinical trials operations in the region under guidance of the Regional Clinical Study Manager.

• Supports the alignment of regional deliverables with overall study goals under the direction of the Regional Clinical Study Manager.

• Might participate in internal working groups, initiatives.

• Performs other tasks assigned by the line manager.

Essential Functions of the job:

Regional Trial Support & Collaboration

• Develops regional study management experience by supporting to oversee multiple aspects of clinical trial conduct including feasibility assessment, study start-up, document generation and review, tracking of samples and enrollment of study participants.

• Develops country study management experience by supporting CRAs and SSUSs with multiple aspects of clinical trial conduct including CTMS updates, ISF binder preparation, document collections, ICF customization, eTMF maintenance (document filing, reconciliation and review at site level or country level.

• Acquires solid knowledge of clinical research operations, including interpretation and implementation of regulations/ICH guidelines.

• Supports the Regional Clinical Study Manager with set up and logistics of regional team meetings (agenda, minutes, etc.).

• Supports the Country Heads with set up and logistics of country team meetings (agenda, minutes etc.).

• Establishes good collaboration with key stakeholders regionally, globally and at country level (Regional Clinical Study Manager, Regional Clinical Trial Management Associate, Global Study Management Associate, Clinical Research Associates and Study Start-up Specialists).

• As required, supports CRAs with various activities such as monitoring visit preparations, equipment management, Contract support, EC/regulatory submission preparation/tracking, TMF filing, SUSAR submission, etc.

• undefined

Timelines, Planning and Execution

• Creates and maintains regional/country level SharePoint folders for the study and regional study team distribution lists.

• Sets up the countries and sites in the region in the appropriate systems e.g., eTMF, CTMS, etc. and makes sure information is kept up to date.

• Supports system access requests for the region/country and ensure these are managed appropriately across the study life cycle, supports user account management for users in region.

• Might support the local adaptation of global documents under supervision of the Regional Clinical Study Manager.

• May assist in the review of study-related documents as they relate to the supported clinical trials as delegated by the Regional Clinical Study Manager (e.g., Informed consent forms, regional Pharmacy Manual, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines and other relevant regional study plans and charters).

• Supports study start up in region/country in close collaboration with the regional study start up team and the Regional Clinical Study Manager.

• Supports the organization of study specific investigator meetings together with the Regional Clinical Study Manager and the Global Study Management Associate.

• Supports the TMF specialist with country/site level TMF creation and maintains the country/site level TMF including regular review and QC of TMF documents as per the study TMF QC plan.

• Helps resolve any regional/country specific issues related to clinical supplies in collaboration with relevant stakeholders.

• Supports the data cleaning activities and contributes to the follow up of outstanding information for region/country.

• Prepares site newsletters and other correspondence related to clinical trial conduct (e.g., best practices and lessons learned, frequently asked questions) in collaboration with the study team.

• Might assist in resolution of routine study questions from clinical trial sites.

• Might support the maintenance of information for region/country in relevant public registries (e.g., CT.gov).

• Supports the Regional Clinical Study Manager by providing all relevant information from region/country to be included in the Clinical Study Report.

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Quality

• Supports the identification of operational risks and works with the Regional Clinical Study Manager to recommend solutions for discussion with appropriate team leadership.

• Learns and shares best practices in clinical operations methodologies, systems and processes with the emphasis on quality and compliance.

• Might support the preparation of sites for quality assurance audits and inspections.

• Suggests improvements to enhance the efficiency and quality of the work performed on assigned projects.

• Might support the development of local/regional tools, working instructions, and SOPs.

Budget

• Supports set up of vendors for activities outsourced in region/country.

• Supports management of regional study budget incl PO set up.

• Supports PO set up for regional vendors.

• Supports with payments follow up (sites, stakeholders).

• Might assist with accrual activities if required.

Supervisory Responsibilities:

N/A

Computer Skills:

• MS Office, eTMF, CTMS

Other Qualifications:

• Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes.

• 1 or more years of experience in clinical research within biotech, pharma or CRO industry.

Travel:

• Limited travel might be required

Education Required:

Preferably Bachelor’s Degree, preferably in a scientific or healthcare discipline required*, Higher Degree preferred

*Exceptions might be made for candidates with relevant clinical operations experience

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.