Study start-Up and activation: 

Deploys Global Site and Study Operations (GSSO) site strategies by qualifying and activating assigned site 

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 

Collaborates with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care (SOC) and medical practices (as applicable) under supervision 

Maintains a 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 activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation (e.g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc.)  

Supports country specific ICD review and deployment up to Site Activation   

Ensures follow up activities’ completion post PTA and SIV to ensure site readiness for First Subject First Visit (FSFV)    

Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness in anticipation of FSFV  

Responsible for relationship building and operational quality of the site  

Responsible for establishing and maintaining relationships with Site Organizations and Strategic Partners  

Provides study support on 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; Jointly responsible with CRA for enrollment delivery during study conduct   

Partners with local Regulatory Authority (RA)/ Clinical Trial Regulatory Operations (CTRO) / Site Activation Partner (SAP) to ensure timely completion on country / local registry up to Site Activation   

Intelligence gathering 

Provides input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics  

Provides support to the Study Operations Manager/Global Study Manager to define local requirements for the importation/exportation processes of the investigational medical product and ancillary suppl 

Study conduct and closeout: 

Reviews Site Reports and related issues  

Assures quality and consistency in the delivery of monitoring  

Supports the CRA to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Study Management  

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 and Technical Competencies:  

Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements  

Must demonstrate good computer skills and be able to embrace new technologies  

Good communication, presentation, and interpersonal skills  

Ability to manage required travel   

Demonstrated networking and relationship building skills  

Demonstrated ability to manage cross functional relationships  

Ability to communicate effectively and appropriately with internal & external stakeholders   

Ability to adapt to changing technologies and processes  

Knowledge of country requirements for GCP that may be different to those of client procedures  

Behavioral Competencies:  

Effectively overcoming barriers encountered during the implementation of new processes and systems  

Identifies and builds effective relationships with investigator site staff and other stakeholders   

Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization  

Able to manage issues that are escalated by site staff in a way that meets the needs of both the client and the site staff  

Knowledge and Experience:   

Demonstrated experience in site management with prior experience as a CRA  

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  

Education:  

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5 years’ experience)  

Proficiency in local language preferred. English is required