Clinical Site Manager

Description

• Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the Clinical Team and key internal stake holders throughout the life cycle of clinical trials.
• Support clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles and using motivational tactics to ensure timely delivery of Clinical trials.
• Engage, evaluate and develop a global network of high performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of Client and its activities thereby increasing their desire to partner with Client.
• Develop & maintain relationships with site engagement organizations; assist in identification of high performing sites and key opinion leaders that can contribute to Client forums, boards and/or discussions.
• Interact/train new investigators to work on clinical trials.
• Responsible for all kinds of site visits (e.g. Selection / Initiation / Monitoring / Close-out / Motivational / Support) and sites’ performance regarding set-up, conduct and data collection.
• Primary contact for sites regarding study-related issues.
• Responsible for the early engagement with Key Opinion Leaders (KOLs)/ sites / patients organizations and key contact point for these throughout the study.
• Interact/train new investigators to work on clinical trials.
• Attend key therapeutic trainings/meetings and/or industry trainings.
• Support Clinical Project Manager in management of the study, including but not limited to:
• Close cooperation with the Clinical Project Managers and members of the Clinical Trial Teams to inform on all aspects of the clinical trial status at site.
• Ensure appropriate engagement and communication with internal stakeholders regarding site visits and related activities.
• Support the development of key study documents including, but not limited to Case Report Form (CRFs), diaries, informed consent/ participant information, the study concept and protocols/amendments including presentations and Investigator Meetings or other trial-related meetings.
• Prepare and/or review monitoring tools, e.g. monitoring manual.
• Support CRO/vendor selection activities and provide input in development of contract specifications regarding monitoring activities for clinical trials.
• Review and approval of site regulatory packages.
• Prepare or review responses to questions from Regulatory Authorities and IRBs/ECs.
• Contributes to updates of clinical program information, e.g., annual safety updates
• Investigator’s Brochure, and on query resolution, as needed, etc.
• Depending on trial setting:
• Train appropriate internal and CRO personnel on trial-specific monitoring requirements.
• Track monitoring activities including review of regulatory package status, visit reports, queries (nature and frequency), and ensure timely collection of the data.
• Conduct co-monitoring visits with Client internal or CRO personnel to ensure quality of trial and initiate corrective actions where appropriate.
• Utilizing all applicable Decentralized Clinical Trial (DCT) methods.
• Shares insights, innovation opportunities and patient needs internally to the team, through collaboration with the Client innovation/ Technology Transformation Implementation (TTI) Teams.
• Such other responsibilities and projects that the Company may assign, e.g., cooperation on SOPs.
• In collaboration with Clinical Project Manager /study team, ensure that the study is audit/inspection ready at all times and any resulting findings from audits/inspections are addressed appropriately and in a timely manner.

Qualifications

• A minimum of 5 years of experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in site engagement or an investigator facing role (e.g. clinical project manager, study director/coordinator, clinical research associate, patient/site engagement companies) .
• At least three years’ experience in monitoring of trials in clinical development environment, preferably in phase 2-4 if responsibility for phase 2-4.
• Strong Knowledge of GCP and ICH Guidelines.

Education

• Strong Knowledge of GCP and ICH Guidelines.