Clinical Site Manager

ICON

Italy

About the role

As a Clinical Site Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be responsible for the planning, initiation, coordination and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities to ensure compliance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and regulatory requirements. Engages with clinical sites to develop, build, and maintain strong relationships with investigators/staff that will ensure high quality investigative sites to support client clinical development programs. Collaborate with internal and external stakeholders as well as third party vendors. Provide operational support to the CPM/Sr CPM to deliver the study within planned timelines and according to required standards of quality and compliance. Evaluate, screen and develop high quality investigative sites to support clinical development programs.

What you will be doing

The Clinical Site Manager is a hybrid position 30% Monitoring 70% Site Engagement.

Site Engagement Deliverables:

Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the Clinical Team and key internal stake holders throughout the life cycle of client clinical trial;
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 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 the 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 client clinical trials.

Monitoring Deliverables:

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;
Attend key therapeutic trainings/meetings and/or industry trainings;
Support CPM in management of the study, including but not limited to:
- Vendor management;
- Logistics;
- Selections of Sites;
- Maintenance of study tracking;
- Oversight of the eTMF.
Close cooperation with the Clinical Project Managers and members of the Clinicial Trial Teams to inform on all aspects of the clincial 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.;
Conduct co-monitoring visits with internal or CRO personnel to ensure quality of trial and initiate corrective actions where appropriate.

You are

B.S., M.S. degree in a life science/biological related field preferred. At least four years experience in monitoring of trials in clinical development environment, preferably in phase 2-4;
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);
A demonstrated working knowledge of ICH/GCP Guidelines;
Strong facilitation skills;
Good collaborator;
Excellent verbal and written communication;
Ability to operate effectively within an international and rapidly changing environment;
Ability to supervise monitoring and related activities in a clinical trial;
Ability to work without close supervision; ability to work under stress and within a team environment;
Fluent in English, both written and oral;
Strong technical skills with CTMS, eCRF, eTMF.