Clinical Trial Manager, FSP, Singapore

3 days ago

Singapore Syneos Health Full time

Clinical Trial Manager, FSP, Singapore 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 client and the patient to the center of everything we do. We continually seek ways to simplify and streamline our work, making Syneos Health easier to work for and with. Job Responsibilities Perform site qualification, initiation, interim monitoring, site management activities and close‐out visits (on‐site or remote) ensuring regulatory, ICH‐GCP/GPP and protocol compliance. Evaluate overall site performance, provide recommendations for site‐specific actions, and communicate/escalate serious issues to the project team. Verify that informed consent has been adequately obtained and documented for each subject. Identify and assess protocol deviations, violations and pharmacovigilance issues at investigator sites. Conduct Source Document Review, verify accurate data entry into the CRF, and resolve queries remotely and on‐site. Support investigational product inventory, reconciliation and review storage, ensuring proper handling and record‐keeping. Maintain the Investigator Site File (ISF) and reconcile it with the Trial Master File (TMF); ensure archiving of essential documents per local regulations. Document activities via confirmation letters, follow‐up letters, trip reports and other required project documents per SOPs and the Clinical Monitoring Plan/Site Management Plan. Participate in Investigator Meetings, sponsor face‐to‐face meetings, global clinical monitoring/project staff meetings, and clinical training sessions. Provide guidance towards audit readiness and support preparation for audits and required follow‐up actions. Collaborate with other CRAs or Central Monitoring Associates and ensure training and compliance of all assigned site personnel. Manage site‐level activities and communications to meet project objectives, deliverables and timelines. Qualifications 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. Strong 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. Must be U.S. citizens or permanently authorized to work in the U.S. EEO Statement Syneos Health is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Additional Information Task, duties and responsibilities are not exhaustive and may be expanded at the Company's discretion. Equivalent experience, skills or education may be considered. The Company is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations where appropriate. #J-18808-Ljbffr

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