Clinical Trial Manager, Regulatory Experience

🕒 September 18

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 24%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance and recommend site-specific actions • Verify informed consent processes and protect subject/patient confidentiality • Assess subject/patient safety, clinical data integrity, protocol deviations/violations and pharmacovigilance issues • Conduct source document review and verify clinical data entered in CRFs • Resolve queries remotely and on site within agreed timelines • Support clinical project data review and capture using available hardware and software • Verify electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, dispensing and administration as applicable • Review Investigator Site Files and reconcile them with Trial Master Files • Document activities through letters, trip reports, communication logs and project documents • Support subject/patient recruitment, retention and awareness strategies • Track observations, ongoing status and action items to resolution • Manage site-level activities and communications to meet project objectives, deliverables and timelines • Act as liaison with project site personnel and ensure assigned sites and team members are trained and compliant • Attend investigator and sponsor meetings, global monitoring/project meetings and clinical training • Support audit readiness, audit preparation and follow-up actions • For Real World Late Phase: provide site support through the study lifecycle, perform chart abstraction and data collection, and collaborate 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 • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • Ability to manage required travel of up to 75% on a regular basis • Working knowledge of relevant regulations and company SOPs/processes • For Real World Late Phase: knowledge of local requirements for real world late phase study designs

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture • Diversity, inclusion and belonging-focused workplace

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