Clinical Study Manager - Maidenhead, Berkshire, United Kingdom - Fortrea

Description

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

Fortrea is currently recruiting for a Local Clinical Study Manager to join a large client dedicated Team to work mainly on cutting edge Oncology trials but possibly also Vaccines, Hepatitis and HIV studies.

Main Point of Contact for assigned protocols and link between Country Operations and clinical trial team.

Responsible 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 close out.

Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, quality standards and adverse event reporting requirements internally and externally.

Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.

Performs Quality control visits as required
Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
Responsible for creating and executing a local risk management plan for assigned studies
Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets)
This role is a full time & permanent position to be employed through Fortrea. Clinical Research Manager, CTL, UK, England, Lead CRA, GCP, Oncology, Clinical Project Manager, Field Based, CRO, Pharmaceutical, CTL, Clinical Team Leader, Local Study Manager

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.

Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.

We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

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