Clinical Trial Manager with at least 5 years of experience in clinical research and experience as a CTM working with US - Mexico Home Based

Syneos Health, Inc.

Job Overview

Location

MEX-Remote

Job Type

Full-time

Full Job Description

📋 Description

• We are seeking a Clinical Trial Manager with at least 5 years of experience in clinical research and experience as a CTM working with US - Mexico Home Based.
• Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success.
• Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
• As a Clinical Trial Manager, you will perform site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
• You will verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• You will assess factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• You will conduct Source Document Review of appropriate site source documents and medical records, and verify required clinical data entered in the case report form (CRF) is accurate and complete.
• You will apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• You will utilize available hardware and software to support the effective conduct of the clinical project data review and capture, and verify site compliance with electronic data capture requirements.
• You will perform investigational product (IP) inventory, reconciliation and reviews storage and security, and verify the IP has been dispensed and administered to subjects/patients according to the protocol.
• You will routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness, and reconcile the contents of the ISF with the Trial Master File (TMF).
• You will ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• You will document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
• You will support subject/patient recruitment, retention and awareness strategies, and enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• You will understand project scope, budgets, and timelines, and manage site-level activities / communication to ensure project objectives, deliverables and timelines are met.
• You will be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.
• You will act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA), and ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• You will prepare for and attend Investigator Meetings and/or sponsor face to face meetings, and participate in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to the project specific requirements.
• You will provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
• For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I, and additional responsibilities include site support throughout the study lifecycle from site identification through close-out, knowledge of local requirements for real world late phase study designs, chart abstraction activities and data collection, and collaboration with Sponsor affiliates, medical science liaisons and local country staff.

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis
• US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access.

🏖️ Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.

Skills & Technologies

GCP

Remote

Degree Required

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Syneos Health, Inc.

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About Syneos Health, Inc.

Syneos Health is a global biopharmaceutical services organization providing clinical and commercial solutions. It integrates clinical development, outsourced commercialization, consulting, and communications services to accelerate the delivery of therapies to market. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of product development and commercialization, operating in North America, Europe, and Asia-Pacific.

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