Senior Site Management Associate I - Real World & Late Phase studies

Job responsibilities
• Perform site management activities in compliance with the Company and Sponsor (if applicable) Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Assure compliance with local regulations and appropriate guidance depending on assigned study design / classification. May include Good Pharmacoepidemiology Practices (GPP) and/or International Conference on Harmonization - Good Clinical Practice (ICH-GCP).
• Conduct site management activities as per agreed Scope of Work (SoW), Site Management Plan (SMP) and relevant guidelines.
o Site identification – may contact sites to obtain interest in study participation, confirm contact details, retrieve documents for consideration, etc.
o Site Qualification - Ensures selection of appropriate sites for assigned studies.
o Site Start-Up –Expert ability to perform activities for assigned sites working with study start-up and regulatory.
o Conduct of all remote and on-site monitoring activities through all study stages.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and SMP, within required timelines. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Demonstrates diligence in protecting the confidentiality of each subject/patient.
• Assigned sites data review, assisting with data query resolution and missing data follow-up (only as applicable). Review data using data trend reports and knowledge of site practices. Ensure the resolution of data queries within agreed timelines. Utilize available hardware and software to support effective study data collection and review.
• Maintain effective, accurate and timely communication with site staff and project team, and ensure appropriate issue escalation and resolution as per SOPs with a focus on issue prevention.
• Maintains clinical tracking and management systems.
• Ensure all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements/data collection tools and safety reporting.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. • May attend Bid Defense Meetings, Investigator Meetings and/or sponsor face-to-face meetings.
• As required, collaborate and build relationships with Sponsor affiliates, medical science liaisons, and local country sponsor staff.
• Consult with Study Start-Up experts and RWCC to maintain current information of local and regional requirements for real world research study designs/classifications.
• Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Clinical Operations Lead or designee, to changing priorities to achieve goals / targets.
• Identify and communicate out of scope activities to Clinical Operations Lead.
• Attend, contribute to and present at study and department meetings.
• Identify operational efficiencies and process improvements to enhance Clinical Operations service delivery.
• May provide training or mentorship to more junior level SMAs. May perform training and sign off visits for junior SMA staff, as assigned.
Qualifications - External
What we’re looking for
• BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience.
• Must be proficient in Microsoft Office Suite (Word, Excel, and PowerPoint), email/voicemail, and Clinical Trial Management and EDC systems.
• Previous site management (in-house, on-site, Study Coordinator) or equivalent experience.
• Excellent communication, time management, organizational, documentation and customer service skills.
• Knowledge of local requirements for Real World Late Phase study designs as well as Real World Research and relevant regulations including GPP.
• Excellent customer focus (internal and external) and able to interact professionally with a client organization and study site.
• Willingness to work within a team-oriented environment. Ability to work in a “virtual” team setting as well as work independently, seeking guidance as appropriate.
• Ability to handle multiple tasks (across multiple studies as necessary) and prioritize accordingly to achieve study timelines. Sound problem solving and analytical skills.
• Excellent command of written and spoken local language, if not English, as well as English required.
• Ability to develop good working relationships via oral communication and good phone etiquette.
• Ability to travel up to 60% on a regular basis depending on assignments and study phase.