Clinical Trial Manager

Overview

Clinical Trial Manager I

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

• WORK HERE MATTERS EVERYWHERE

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment to evaluate site and site staff performance and provide recommendations regarding site-specific actions; communicates/escalates serious issues to the project team and, with guidance, develops action plans. Maintains working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent for each subject/patient, and demonstrates diligence in protecting confidentiality. Assesses factors that might affect subject/patient safety and data integrity at investigator/physician sites (e.g., protocol deviations/violations and pharmacovigilance issues).
• For the CMP/SMP:
  Assess site processes, conduct Source Document Review of site source documents and medical records, verify CRF data accuracy/completeness, apply query resolution techniques remotely and on site, and guide site staff to resolve queries within agreed timelines. Utilize available hardware/software to support data review and capture. Verify site compliance with electronic data capture requirements.
• May perform investigational product (IP) inventory, reconciliation and storage/security reviews. Verify IP dispensing and administration per protocol. Address issues or risks related to blinded or randomized IP information. Ensure IP labeling, import, and release/return in accordance with GCP/local regulations and procedures.
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness; reconcile ISF with the Trial Master File (TMF). Ensure site archiving of essential documents in accordance with local guidelines and regulations.
• Document activities via letters, trip reports, logs, and other required project documents per SOPs and the Clinical Monitoring Plan/Site Management Plan. Support subject/patient recruitment, retention and awareness strategies. Enter data into tracking systems to track observations, ongoing status, and action items to resolution.
• Understand project scope, budgets, and timelines for assigned activities; manage site-level activities/communication to meet project objectives and timelines. Adapt to changing priorities with oversight from the Lead CRA.
• Act as primary liaison with project site personnel or in collaboration with another CRA or CMA. Ensure all assigned sites and site team members are trained and compliant with applicable requirements.
• Prepare for and attend Investigator Meetings and sponsor face-to-face meetings. Participate in global clinical monitoring/project staff meetings and training sessions as required by the project.
• Provide guidance at the site and project level towards audit readiness and support preparation for audits and required follow-up actions.
• For Real World Late Phase, the CRA I will use the business card title Site Management Associate I. Additional responsibilities include site support throughout the study lifecycle, knowledge of local requirements for…