RWE - Sr Site Mgr 1

PURPOSE
Ensure clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements by engaging with assigned sites. Workload will include complex projects.
RESPONSIBILITIES
• May perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions.
• Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
• Work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.
• Execute assigned work efficiently and adhere to project timelines and financial goals; may provide Site and Patient Services performance metrics and make recommendations based on their findings.
• Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
• May assist in preparation for in-house audits and in creation of Corrective Action Plans (CAPAs).
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.
• May provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities. May act as point of contact for other Site Managers on the project.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Strong knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
• Strong written and verbal communication skills in applicable languages, and business level command of English
• Strong organizational, interpersonal and problem-solving skills
• Strong attention to detail
• Working time management skills
• Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor’s Degree preferably in life science, and 3 years of monitoring experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS
• Extensive use of telephone and face to face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• May require occasional travel