Overview

Reference Number: JO-2007-452478
Associate Clinical Trial Manager
Rate: Negotiable
Job Type: Permanent
Location: Miami

Associate Clinical Trial Manager
Location: Miami, remote
Ideally Spanish speaking individual
Overview of Role:
Under the direction of the Clinical Trial Lead and the Regional Director, the Associate Clinical Trial Manager will conduct CRO oversight activities on a regional basis, ensuring Summit sponsored clinical trials are conducted in accordance to ICH/GCP and delivered on time and on budget.

Responsibilities:
Performs oversight activities of the CRO per the Vendor Oversight Plan.
Conducts co-monitoring in designated region(s)
Responsible for the review of clinical trial documents including (but not limited to) consent documents, confidentiality agreements, study related plans and Investigator agreements (CTAs).
Responsible for oversight of IRB/EC and RA submissions within designated region(s)
Vendor manager of 1 or more vendors
Reviews and approves essential document packages to enable timely site activations.
Reviews pre-study, study initiation, interim monitoring visit and study closeout visit reports and ensures findings are addressed with the CRO and looped back to the wider study team as required.
Partners with the CRO to ensure robust ongoing quality monitoring strategies are carried out effectively to deliver high-quality data.
Oversees investigator performance and adherence to protocol, and proactively addresses conduct issues and enrolment problems, as necessary.
Responsible for oversight and maintenance of the TMF and completeness at the end of the study.
Ensures study inspection readiness.

Qualifications
Bachelors degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
A minimum of 2 years of experience in relevant role (eg. Sponsor, CRO or Clinical Study Vendor)
Vendor (CRO) oversight experience preferred
CRA experience preferred
Experience with clinical studies in infectious or rare diseases a plus
Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 30%).

Competencies & Skills:
Spanish Language skills
Proficiency working on large complex studies being managed by a CRO.
Demonstrated ability to work in a fast-paced team environment with high productivity.
Enjoys building strong working relationships with colleagues and CRO personnel.
Possesses drive, energy and enthusiasm to deliver the study objectives.
Strong planning, time management & coordination skills.
Excellent verbal, written, interpersonal and presentation skills.
Has a keen eye for measuring what matters.
Ability to work with a cross functional team to enable problem solving in consideration of regulatory requirements, interactions with external parties and timelines.

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