Clinical Research Manager (remote-based)
- Permanent
- Clinical Operations, Clinical Trial Administration
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Hobson Prior currently have an opportunity for a Clinical Research Manager to work remotely for a global pharmaceutical organisation who are driven to help improve and prolong life. This role is mainly accountable for the end to end performance and project management for assigned protocols in a country.
Job Responsibilities:
- Represent as the main point of contact for assigned protocols and link between Country Operations and clinical trial team.
- Responsible for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Accountable for creating and executing a local risk management plan for assigned studies.
- To ensure compliance with Clinical Trial Management System, electronic Trial Master File and other key systems in assigned studies.
- Escalates as needed different challenges and issues to TA Head/Clinical Research Director/Clinical quality manager and or CTT (as appropriate).
- Accountable for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
- Accountable for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and closeout.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Completes Quality control visits as required.
- To leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports Clinical Research Associates as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration.
- Any other assigned duties.
Key Skills:
- Strong organizational skills with demonstrated success required.
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CR.
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.
- Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery.
- Proficient in written and spoken English and local language.
- Strategic thinking.
Requirements:
- Bachelor's degree in science (or comparable).
- At least 5-6 years of experience in clinical research (oncology experience is an asset).
- CRA experience (asset).
- Knowledge in Project Management and site management.
- Requires strong understanding of local regulatory environment.
- Strong scientific and clinical research knowledge is required.
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
Apply now:
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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