Job Responsibilities
Perform site management activities in compliance with Company and Sponsor Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Assure compliance with local regulations and appropriate guidance for assigned study design/classification, including Good Pharmacoepidemiology Practices (GPP) and International Conference on Harmonisation Good Clinical Practice (ICH‑GCP).
Conduct site management activities as per agreed Scope of Work (SoW), Site Management Plan (SMP) and relevant guidelines.
Site identification – contact sites to gauge interest, confirm contact details, and obtain relevant documents.
Site qualification.
Ensure selection of appropriate sites for assigned studies.
Site start‑up with minimal supervision, working with study start‑up and regulatory teams.
Conduct all remote and on‑site monitoring activities through all study stages.
Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness; reconcile its contents with the Trial Master File (TMF); and ensure sites archive essential documents per local guidelines.
Document activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents per SOPs and SMP; support subject recruitment, retention, and awareness strategies; and enter data into tracking systems to monitor observations, status, and action items.
Demonstrate diligence in protecting the confidentiality of each subject or patient.
Review assigned site data, assist with data query resolution and missing data follow‑up; analyze data using trend reports and site practices; ensure timely resolution of data queries; and use available hardware and software to support effective study data collection and review.
Maintain effective, accurate and timely communication with site staff and the project team; ensure appropriate issue escalation and resolution per SOPs with a focus on issue prevention.
Maintain clinical tracking and management systems.
Ensure all assigned sites are trained and compliant with study protocol, informed consent process, data collection requirements/tools, and safety reporting.
Provide guidance toward audit readiness at the site and project levels and support audit preparation and follow‑up actions.
Prepare for, attend, and participate in Investigator Meetings and/or sponsor face‑to‑face meetings.
Collaborate and build relationships with Sponsor affiliates, medical science liaisons, and local country sponsor staff as required.
For assigned activities, understand project scope, budgets, and timelines; manage site‑level activities and communications to meet project objectives, deliverables, and timelines; and adapt quickly to changing priorities under the oversight of the Clinical Operations Lead or designee.
Identify and communicate out‑of‑scope activities to the Clinical Operations Lead.
Attend, contribute to, and present at study and department meetings.
Qualifications
Minimum 1 year relevant onsite monitoring experience.
Proficiency in German language, written and spoken.
BA/BS degree in a science/health‑care field, nursing degree, or equivalent combined education and experience.
Proficiency in Microsoft Office Suite (Word, Excel, 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 and relevant regulations, including GPP.
Excellent customer focus and ability to interact professionally with client organizations and study sites.
Willingness to work within a team‑oriented environment; ability to work both virtually and independently while seeking guidance as appropriate.
Ability to handle multiple tasks across studies and to prioritize to achieve study timelines; strong problem‑solving and analytical skills.
Excellent command of written and spoken local language (if not English) and English proficiency.
Ability to develop good working relationships via oral communication and good phone etiquette.
Ability to travel up to 60% as required, based on assignments and study phase.
Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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Perform site management activities in compliance with Company and Sponsor Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Assure compliance with local regulations and appropriate guidance for assigned study design/classification, including Good Pharmacoepidemiology Practices (GPP) and International Conference on Harmonisation Good Clinical Practice (ICH‑GCP).
Conduct site management activities as per agreed Scope of Work (SoW), Site Management Plan (SMP) and relevant guidelines.
Site identification – contact sites to gauge interest, confirm contact details, and obtain relevant documents.
Site qualification.
Ensure selection of appropriate sites for assigned studies.
Site start‑up with minimal supervision, working with study start‑up and regulatory teams.
Conduct all remote and on‑site monitoring activities through all study stages.
Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness; reconcile its contents with the Trial Master File (TMF); and ensure sites archive essential documents per local guidelines.
Document activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents per SOPs and SMP; support subject recruitment, retention, and awareness strategies; and enter data into tracking systems to monitor observations, status, and action items.
Demonstrate diligence in protecting the confidentiality of each subject or patient.
Review assigned site data, assist with data query resolution and missing data follow‑up; analyze data using trend reports and site practices; ensure timely resolution of data queries; and use available hardware and software to support effective study data collection and review.
Maintain effective, accurate and timely communication with site staff and the project team; ensure appropriate issue escalation and resolution per SOPs with a focus on issue prevention.
Maintain clinical tracking and management systems.
Ensure all assigned sites are trained and compliant with study protocol, informed consent process, data collection requirements/tools, and safety reporting.
Provide guidance toward audit readiness at the site and project levels and support audit preparation and follow‑up actions.
Prepare for, attend, and participate in Investigator Meetings and/or sponsor face‑to‑face meetings.
Collaborate and build relationships with Sponsor affiliates, medical science liaisons, and local country sponsor staff as required.
For assigned activities, understand project scope, budgets, and timelines; manage site‑level activities and communications to meet project objectives, deliverables, and timelines; and adapt quickly to changing priorities under the oversight of the Clinical Operations Lead or designee.
Identify and communicate out‑of‑scope activities to the Clinical Operations Lead.
Attend, contribute to, and present at study and department meetings.
Qualifications
Minimum 1 year relevant onsite monitoring experience.
Proficiency in German language, written and spoken.
BA/BS degree in a science/health‑care field, nursing degree, or equivalent combined education and experience.
Proficiency in Microsoft Office Suite (Word, Excel, 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 and relevant regulations, including GPP.
Excellent customer focus and ability to interact professionally with client organizations and study sites.
Willingness to work within a team‑oriented environment; ability to work both virtually and independently while seeking guidance as appropriate.
Ability to handle multiple tasks across studies and to prioritize to achieve study timelines; strong problem‑solving and analytical skills.
Excellent command of written and spoken local language (if not English) and English proficiency.
Ability to develop good working relationships via oral communication and good phone etiquette.
Ability to travel up to 60% as required, based on assignments and study phase.
Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
#J-18808-Ljbffr
