Senior Clinical Data Central Monitor

Central Monitor II/Sr Central Monitor (Hyderabad-Office based)

Central Monitor II/Sr Central Monitor (Hyderabad-Office based)

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 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 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. 

Job Responsibilities

• Consult with project team and customer during development and maintenance whilst adhering to relevant project plans.
• Collaborate with functional and analytical teams to develop project level systems, dashboards, tools and custom reports to support data oversight.
• Perform and document centralized data surveillance using analytics and signal detection, including but not limited to Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), Severe Adverse Events (SAE) and vendor reconciliations, listings, and audit trail reviews.
• Review and interpret study, site and patient-level data, including safety signals, efficacy trends, and protocol deviations, and escalate findings as appropriate.
• Manage queries, action items, edit checks and listings, reporting, and compliance.
• May perform tasks delegated by Clinical Data Surveillance Lead. 
• Analytical skills with the ability to interpret complex clinical datasets.
• Participate in continuous process improvement and adoption of innovative methodologies by leveraging predictive insights and proactively identifying potential risks.
• Oversee site level database readiness requirements, timelines, metric compliance and readiness.
• Support audit readiness and provide regulatory standard compliance oversight and reporting for multiple projects.
• Attend cross-functional study meetings, data review meetings, and risk assessment discussions.
• Perform other work-related duties as assigned.

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 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.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Experience Level

Senior Level