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 knowledge of applicable clinical research regulatory requirements Good Clinical Practice ICH guidelines

• Ability to work independently as well as in a team matrix organization and multiple projects.

• Excellent English and Spanish written and verbal communication skills as well as computer skills

• Excellent organizational and leadership skills

• Ability and willingness to travel up to 20-30%

What We Offer

We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll be joining a team that values collaboration innovation and making a difference in the lives of patients

A Bit More About Us

Our journey began over 29 years ago in Sweden in the city of Lund. As a full-service global Contract Research Organization (CRO) we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.

Our core values of Trust Quality Passion Flexibility and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments resulting in high employee engagement and satisfaction. By aligning on these fundamental values we cultivate a unified force geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Together we make a difference.