Qualifications
Responsibilities
Benefits
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.
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.
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.
BudgetSupports 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
Preferably Bachelors Degree, preferably in a scientific or healthcare discipline required*, Higher Degree preferred
*Exceptions might be made for candidates with relevant clinical operations experience
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
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