General Description:
- Supports the Global Clinical Study Manager in global study delivery and ensures that delegated components of clinical studies are executed to expected and specified quality standards, within timelines and budget
- Supports the alignment of study goals with clinical operations goals andobjectivesunder direction of the Global Clinical Study Manager
- Supports study vendor managementin addition to other study management activities assigned
Essential Functions of the Job:
Cross-Functional Leadership Support & Collaboration
Supports the Global Clinical Study Manager with the organization andlogisticsfor cross-functionalClinical StudyTeam (CST) meetings
Establishes good collaboration with the Global Clinical Study Manager, Regional Clinical Trial ManagementAssociatesand other key stakeholders globally and regionally
Knowledgeable of clinicalstudyoperations, including interpretation and implementation ofregulatory and ICH-GCPguidelines
Builds solid knowledge of global clinical trials operations under the guidance of the Global Clinical Study Manager
Actively contributes to GSMA task force initiatives and cross functional projects within scope, supporting process improvement, standardization, and implementation activities as required
Planning andExecution
Creates andmaintainsstudy-levelSharePoint andCSTdistribution lists
Sets up the study in theappropriate systemse.g.eTMF,CTMS etc and makes sure study-level information is kept up to date
Ensures system access is granted and managed appropriately across the study life cycle, supports user account management for systems used in study
Supports the development ofvariousstudy plans
May assist in the review of study-related documents as delegated by theGlobal Clinical Study Manager(e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters)
Organizes study-specific investigator meetings under supervision of theGlobal Clinical Study Manager
Might support the creationand review ofsite feasibility assessmentsrequiredfor study participation
Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, dataflowand protocol deviationsin relevant systems in collaboration with Regional Clinical Trial Management Associates
Prepares metrics and updates to key deliverables for managementas per information available in relevant systems
Supports the preparation of a study newsletter and other correspondence related to the study conduct (e.g.frequentlyasked questions, lessons learned) in collaboration with the study team
Supports the TMF specialist with study-level TMF creation and, asrequired,maintainsthe study-level TMF, including regular review and QC of TMF documents as per thestudy TMF QCplan
Supports the Global Clinical Study Manager with study drug forecasts and overall study drug supply activities in collaboration with Global Clinical Supplies
Supports the overall data cleaning activities and contributes to the follow-up of outstanding information
Supports theGlobal Clinical Study Managerwith planning and execution of the Clinical Study Report
Quality
Supports the identification of operational risksand issuesand works with theGlobal Clinical Study Managerto recommend solutions for discussion withappropriate teamleadership
Learns and shares best practices in clinical operations methodologies,systemsand processes with an emphasis on quality and compliance
Suggestimprovements to enhanceefficiencyand the quality of the work performed on assigned projects
Might support the development of global study tools, working instructions and SOPs
Budget
Supports selection and set-up of vendors for global outsourced activities
Supports study budget management activities with responsibility for PO setup and payment invoice tracking across all study lifecycles.
Supervisory Responsibilities:
Might mentor junior team members/onboarding of new hires
Computer Skills:
Proficiency in MS Office Suite, including Excel, PowerPoint and project etc.
Other Qualifications:
- Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes
- 3 or more years of experience in clinical research within Biotech, Pharma or CRO industry
Travel:
- Limited travel might be required
Education Required:
- Bachelor or higher degree in a scientific or healthcare discipline*, higher degree preferred.
- *exceptions might be made for candidates with relevant clinical operations experience
