Clinical Research Manager (CRM) - Spanish Speaker

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a Clinical Research Manager (CRM) - home based in East Coast, US.

If you have a minimum of 5 years clinical operation experience in a CRO setting (plus no less than 1 year of CRM experience) with at least 1+ year of OPH experience and are fluent in Spanish and English - we want to hear from you!

About this role

As part of our CDS Ophthalmology team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Clinical Research Manager (CRM) is is part of Clinical Operations Unit within TFS Clinical Development Services and will function operationally as a member of a Project Team being responsible of coordinating and overseeing the country and site management activities during study conduct, according to company policies, SOPs, and regulatory requirements in addition to financial and contractual obligations.

The CRM will be reporting to the Project Manager being responsible of certain aspects of project activities which may include country and site tracking, monitoring plans, review of monitoring reports and study monitoring resources management.

Key Responsibilities:

• Project oversight and responsibility over clinical operations deliverables

• Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to the applicable SOPs, protocol requirements, study specific plans, ICH/GCP and all other applicable laws, rules, and regulations.

• Serve as primary Sponsor contact for operational project-specific issues and study deliverables.

• Lead, manage and guide CRAs ensuring all necessary project-specific training is provided, carried out, and documented.

• Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables.

• Development of Study Monitor plans, Monitor and Site Training plans, verification initiatives, coordinating Study Investigator Meetings and reviewing site and country Study Reports.

• Ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from study feasibility through to close out.

• Serve as initial point of contact for the monitoring team and support them with investigative site personnel liaison.

• Implement monitoring/recruitment plans and support also the design of CRF completion guidelines.

• Perform co-monitoring visits as part of the monitoring team quality oversight.

• Review and approve site visit reports (PSV, SIV, MV and COV) with agreed and act as first point of contact for issue escalation ensuring the proper resolution and action plan definition and follow up.

• Review CRA Site Visits calendar ensuring monitoring visits (both remotely and on site) are being scheduled and conducted following monitoring plan frequency.

• Reviewing protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns.

• Leading and guiding the internal clinical study team and chairing study team meetings.

• Update the Project Manager with status of sites and countries and ensure a proper escalation of any issue detected at site/country level.

• Ensure documents remain current during the trial and ensure proper maintenance of Trial Master File being responsible of QC when delegated by Project Manager

Qualifications:

• Degree in clinical, science or health related field

• 5+ years of clinical research experience, as a CRA, including relevant on-site monitoring experience.

• Minimum of 5 years clinical operation experience in a CRO setting (plus no less than 1 year of CRM experience) with at least 1+ year of OPH experience - this is mandatory

• Able to work in a fast-paced environment with changing priorities.

• Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas.

• In-depth knowl