Senior Clinical Research Associate

Sr Clinical Operation Specialist / Lead Clinical Operation Specialist (Immediate Joiner)Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. 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. 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 deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos HealthWe 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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.Roles And ResponsibilitiesSupport set-up and maintenance of information in Clinical Trial Management Systems and other systems as applicable, independent or under the responsibility of (Sr.) Clinical Project Manager as applicable: Update data, timelines, milestones, Ethics Committee /, Health Authority authorizations, etc. on an ongoing basis.Support (Sr.) CPM with study budget management, ensuring accurate planning, tracking and reporting of clinical study budget and Grant Plan as applicable. Perform Good receipt booking in line with Vendor financial report and study status, as required.Support set-up and maintenance of Trial Master File: Ensuring that all key documents are present and filed as appropriate in TMF, independent or under responsibility of (Sr.) CPM as applicable. Follow up with Clinical Trial Team at agreed frequency for TMF maintenance.Track clinical studies/projects/activities progress, ensure CTMS, TMF and other systems as applicable are up to date. Address questions; escalate issues or critical findings to project lead (Sr./CPM).Support in External Service Provider coordination:1. Support (Sr.) CPM in set up and coordination of External Service Providers, ensuring all information, documentation and material in place for clinical study/projects/activities at start, conduct and close-out.2. Follow-up with External Service Providers on day-to-day operations3. Ensure all data is reported to the Clinical Trial Team (CTT) and available to business colleagues4. Logistical support to study team (internal and external) onboarding processSupport in meeting set up, coordination and meeting minutes, running reports from systems, draft project documentation.Support CTT in study start-up activities, recruitment and close-out activities as required.Champion the implementation of operational changes and transitions as required.COS may additionally support below activities as deemed necessary by reporting manager or Head CPM:1. Responsible for developing monitoring plans and study specific tools as applicable2. Provide input to eCRF design & review, and other documents and systems, as applicable3. Responsible for central monitoring and data oversight on assigned clinical study(s) using available online data sources (eCRF, IRT, central lab, etc.) to ensure consistency, plausibility, completeness and correctness of the data4. Communicate any observations, deviations to protocol, safety alerts, quality issues, trend/patterns, risk factors etc. to the clinical team and CRAs for timely follow-up of actions and issue resolution5. Collaborate with Medical Lead to identify any safety trends, is a key team member of the ClinicalTrial Team and will lead the discussion in Data Review Team (DRT) meetings6. Prepare and share the Central Monitoring Package where applicable and agreed with the CRAs prior to monitoring visitsGet to know Syneos HealthOver 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 what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.