Supporting Activities may include but not limited to the following:
Intelligence Gathering:
• Provides input into site recommendations via intimate understanding of country and region, sites, processes and practices, and associated site performance metrics
• Provides support to the Study Operations Manager (SOM)/Global Study Manager (GSM) to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies
Study Start-Up and Activation:
• Deploys Global Site and Study Operations (GSSO) site strategies by qualifying and activating assigned sites
• Supports processes to optimize country and site selection activities including review and assessment of the draft potential site list and provide Pre-Trial Assessment (PTA) output for site selection
• Maintains a thorough knowledge of assigned protocols
• Conducts study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, Informed Consent Document (ICD) finalization, Site Initiation Visit (SIV), as applicable, including management of issues that may compromise time to site activation
• Ensures all the site initiation activities completed including training per site activation checklist, collect and complete necessary documentation and systems needed
• Supports country specific ICD review and deployment when applicable
• Ensures follow up activities are completed post PTA and SIV to ensure site readiness for First Subject First Visit (FSFV)
• Partners with site monitor to ensure site monitoring readiness in anticipation of FSFV
• Responsible for relationship building and operational oversight of the site
• Provides support for escalated site issues related to study delivery by coordinating communications and resolution efforts (e.g., vendor, site contracts and payment issues etc.)
• Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country requirement throughout the lifecycle of the study
• Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets
• Responsible for enrollment support and ensures progress by responding to recruitment issues from investigators
• Maintains regular communications with investigator sites to gather status updates and drive delivery to study goals (e.g. recruitment, data entry timelines etc.)
• Partners with local Regulatory Authority (RA)/ Clinical Trial Regulatory Operations (CTRO) / Site Activation Partner (SAP) to ensure timely completion on country / local registry when applicable
Study Conduct and Closeout:
• Acts as operational point of contact for all site level questions, liaising with and escalating to appropriate teams to respond and resolve questions
• Reviews site monitoring reports
• Supports the site with revision and submission of ICD documents (and amendments)
• Works with other roles to maintain system management (e.g., Electronic Data Capture, Shared Investigator Platform, Site Profile and other systems as applicable) at site level ensuring alignment across platforms
• During the conduct of the study, the Site Management Organization (SMO) Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed under client/ Senior SCP supervision. In addition, SMO Assessment is reviewed and updated when major staffing, contracting, or other significant site changes/issues occur to confirm that continuity and contingency plans are current
• Reviews and manages site practices that differ from client practices and liaises with study management and Business Process Owners as needed
• Maintains regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study level feedback
• Oversees and manages of site deliverables to study targets, (i.e. data cuts and sweeps, interim analyses, database locks), helping to oversee data is up to date and any other site facing deliverables, (i.e., investigator signatures)
• Follows the study oversight plan and proactively puts in place mitigations for known and anticipated risks
• Supports development and delivery, including issue resolution, of decentralized capabilities at investigator sites
• Assures quality and consistency in the delivery of monitoring
• Drives monitoring efficiencies and best practices for study, region and program
• Supports shaping the local clinical development environment with a goal to enhance client reputation in scientific leadership
• May act as a Subject Matter Expert (SME) on client systems and processes
• Actively pursues efficiencies and develops best practices in the delivery of activities for site performance throughout the life cycle to increase investigator and site satisfaction strengthening site relationships
Collaboration:
• Ensures clear and open communication with SOM
• Supports the site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Country Trials Manager (CTM) and Study Management
• Coordinates with other roles and functions that interface with study sites (e.g., Study Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) optimizing communications and enhancing overall visibility into and confidence of quality of site level activities
Process, Standards, and Oversight:
• Oversees site utilizing and interpreting data from analytic tools, with country intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans for these risks
Compliance with Parexel standards:
• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
• Demonstrated experience in site management with prior experience as a site monitor
• Demonstrated experience in start up activities through to site activation
• Demonstrated experience in conduct and close out activities
• Demonstrated knowledge of quality and regulatory requirements in applicable countries
• Must demonstrate good computer skills and be able to embrace new technologies
• Ability to communicate effectively and appropriately with internal and external stakeholders
• Ability to adapt to changing technologies and processes
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
• Effectively overcomes barriers encountered during the implementation of new processes and systems
• Demonstrated networking and relationship building skills
• Demonstrated ability to manage cross functional relationships
• Identifies and builds effective relationships with investigator site staff and other stakeholders
• Proficiency in local language preferred
• English proficiency is required
• Ability to manage required travel of up to 75% on a regular basis
Knowledge and Experience:
• Good communication, presentation and interpersonal skills
• Knowledge of country requirements for GCP that may be different to those of client procedures
Education:
• Bachelor’s degree or Registered Nurse in a related field or equivalent combination of education, training and experience (estimate at least 5 years experience)
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