Sr.CRA (Oncology experience required), FSP, Singapore

Sr.CRA (Oncology experience required), FSP, Singapore Location: SGP-Client   Job ID: Overview Sr.CRA (Oncology experience required), 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 centers the customer and the patient, and we continually seek ways to simplify and streamline our work to be easier to work for and with. 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. WORK HERE MATTERS EVERYWHERE Why Syneos Health 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 our Total Self culture – where you can authentically be yourself. Our Total Self culture unites us globally, and we take care of our people. We are building the company we want to work for and our customers want to work with. Diversity of thoughts, backgrounds, cultures, and perspectives helps everyone belong. Responsibilities Performs site qualification, site initiation, interim monitoring, site management and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and/or GPP and protocol compliance. Uses judgment to evaluate site performance and provides recommendations; communicates/escalates serious issues to the project team and develops action plans. Maintains knowledge of ICH/GCP guidelines, relevant regulations, and SOPs/processes. Verifies informed consent processes and documentation; protects subject confidentiality. Assesses factors affecting subject safety and data integrity at investigator/physician sites (e.g., protocol deviations, pharmacovigilance issues). Per CMP/SMP: assesses site processes, conducts Source Document Review, verifies CRF data accuracy via source documents, and applies query resolution techniques. Uses hardware/software to support data review and verifies ISF/TMF alignment and archiving requirements. May perform IP inventory, reconciliation and storage reviews. Verifies IP dispensing per protocol and handles labeling, import, release/return per GCP/local procedures. Routinely reviews ISF accuracy and timeliness; ensures archiving per guidelines. Documents activities via letters, reports, logs, and other project documents; supports recruitment and retention strategies; enters data into tracking systems. Understands project scope, budgets, and timelines; manages site-level activities and communications to meet objectives. Adapts to changing priorities. May act as primary liaison with site personnel or collaborate with Central Monitoring Associate. Ensures training and compliance of sites and team members. Prepares for and attends Investigator Meetings; participates in or leads global clinical monitoring/project staff meetings and attends clinical training as required. Provides guidance toward audit readiness and supports audit preparation and follow-up actions. May mentor junior CRAs; may perform training and sign-off visits as assigned. May be mentored and assigned operational lead tasks under supervision of an experienced COL. For RWLP, responsibilities include: site support lifecycle, knowledge of real-world late-phase study designs, chart abstraction, collaboration with Sponsor and affiliates, identifying out-of-scope activities, suggesting sites, process improvements, and bid defense participation. Qualifications Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience Knowledge of GCP/ICH Guidelines and regulatory requirements Strong computer skills and ability to adapt to new technologies Excellent communication, presentation, and interpersonal skills; basic critical thinking Ability to travel up to 75% regularly Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients. No matter your role, you’ll take initiative and challenge the status quo in a dynamic environment. Learn more about Syneos Health: Additional Information Tasks, duties, and responsibilities as listed are not exhaustive. The Company may assign other tasks at its discretion. Equivalent experience, skills, and/or education will be considered. The Company will determine what constitutes as equivalent qualifications. This does not create a contract of employment. Some required skills may be expressed in brief terms. This content complies with applicable laws in each country of operation, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations if needed for the application process. Summary Roles within Clinical Monitoring/CRA involve on-site and remote monitoring to ensure trials are conducted per clinical practices. This includes developing tools and processes to ensure quality monitoring. This position may involve directing work of others and contributing to processes and policies within the professional discipline. Syneos Health is dedicated to a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway and consider transferable skills. We also invite you to join our Talent Network to access more career opportunities. Syneos Health® (Nasdaq: SYNH) is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes. We support a diverse, equitable and inclusive culture. Contact: Job inquiries may be directed to Phone: | Fax: | Toll-Free: Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you require reasonable accommodation to complete any part of the application process, please contact us at #J-18808-Ljbffr