RWE Site Manager
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Job Description
Remote site monitoring for clinical research as RWE Site Manager at IQVIA. Collaborating with clinical operations and ensuring compliance with protocols and regulations.
Responsibilities:
- 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 requirements.
- Completes appropriate therapeutic, protocol and clinical research training to perform job duties.
- Perform Site ID, and site selection activities according to applicable regulations and Standard Operating Procedures (SOPs).
- Perform as needed SSU activities according to applicable regulations and SOPs.
- Perform as needed, initiation, monitoring, and close out visits remotely in accordance with contracted scope of work.
- Serve as primary contact between the business and the investigator site.
- Collaborate 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.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with site specific information.
- Provide input and updates to the assigned COL regarding site status and deliverables.
Requirements:
- Bachelor's Degree preferred or as required by local country policies.
- Minimum of 1 year of relevant clinical experience preferred.
- Pre-intermediate knowledge of clinical research process and medical terminology.
- Written and verbal communication skills including good command of English language.
- Good organizational and problem-solving skills.
- Ability to manage multiple priorities within various clinical trial.
- Ability to meet deadlines and adhere to project timelines.
- Ability to work independently on routine tasks and apply critical thinking to tasks with guidance, as needed.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Ability to understand electronic data capture including basic data processing functions.
- Pre-intermediate knowledge of current International Conference on Harmonization (ICH) and GCP guidelines and applicable regulations to the conduct of clinical research.
- Skill in understanding different study designs.
- Computer skills including proficient use of Microsoft Word and Excel.
Benefits:
- Health insurance
- Professional development opportunities
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