RWE Sr. Site Manager

Role– RWE Sr. Site Manager

Duration:6 Months Contract(Remote (Part Time – 4 hours per day)

Location: Poland,

JOB OVERVIEW

With minimal guidance, responsible for remote site monitoring activities to ensure sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor volume. May monitor and/or co-monitor on-site when needed. May perform Site Identification (Site ID) and/or Site Start-Up (SSU) activities.

Responsibilities:

• Completes appropriate therapeutic, protocol, and clinical research training to perform job duties. Works collaboratively with other functional groups such as Clinical Operations Lead (COL), Project Management, Regulatory Start-Up (RSU) and Epidemiology.
• Performs as needed, Site ID, and site selection activities according to applicable regulations and Standard Operating Procedures (SOPs) including but not limited to: Collection of Site Information Form (SIF) and Confidentiality Disclosure Agreement (CDA) and corresponding tracking and filing and might perform Site Selection Visits (SSVs) as needed.
• Performs as needed SSU activities according to applicable regulations and SOPs, including but not limited to: preparing regulatory/ethics submission packages and obtaining required approvals; collecting and reviewing of regulatory documents for completeness and accuracy; tracking and filing site regulatory documents (Including regulatory /ethics submissions / Approvals, Informed Consent Form (ICF) and others), preparing, reviewing and negotiating of site contracts and budgets with investigator sites; reviewing and agreeing on project planning and project timelines.
• Performs as needed, initiation, monitoring and close out visits remotely and in accordance with contracted scope of work, using Good Clinical Practices (GCP), applicable regulations, SOPs, and work instructions. May monitor and/or co-monitor on-site when needed.
• Serves as primary contact between the business and the investigator site and ensures proper documentation of site management communications. Serves as back-up to other Site Managers (SMs).
• In collaboration with the assigned field Clinical Research Associates (CRAs), performs routine site management activities, including, as needed: SSU activities as detailed above, site training, assistance with site questions, patient recruitment and retention management, study supplies management, and other activities needed to ensure that assigned sites are conducting the study(ies) as required by the study
• protocol, applicable regulations and guidelines, and sponsor requirements.
• Collaborates with field CRAs, as needed, to resolve and document outstanding site issues/action items.
• Reviews the quality and integrity of patient data at assigned sites through the remote review of electronic Case Report Form (CRF) data. Ensures timely transmission of clinical data from assigned study sites and
• works with sites to resolve data queries.
• Assists with final data review, query resolution, and patient casebook signature through database lock. Inclusive of patient profile and data listings review.
• Ensures accurate completion and maintenance of internal systems, databases and tracking tools with site specific information, including (but not limited to) submitting regular visit reports, generating follow-up
• letters, collection and filing of essential documents and other required study documentation.
• Provides input and updates to the assigned COL regarding site status and deliverables. Escalate issues and/or risks related to site performance to the COL, Clinical Project Manager (CPM) and/or Line Manager (LM) as needed.
• May assist with and attend (as needed) Investigator Meetings on assigned studies.
• Authorized to request onsite visits and/or site audits for reasons of validity.
• May help ensure timely and appropriate site payments and updates to systems as required to ensure proper timing and amount of payments.
• Conduct assessment visits, as needed, to ensure monitoring is being conducted in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.
• Aid less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation, and other monitoring activities.
• May be assigned COL tasks, as agreed with LM.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, typically requires 2 - 3 years of prior relevant experience.
• Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience