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

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

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 is what unites us globally, and we are dedicated to taking care of our people. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. 

Job Responsibilities

Min 1-3yrs of relevant experience

Good experience of tools like CTMS , Spot fire etc

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.

QUALIFICATION REQUIREMENTS

• ​Bachelor’s degree in life sciences, health sciences or equivalent related experience Bachelor’s, plus nominal experience in clinical data management, centralized monitoring and/or medical scientific management.
• Foundational knowledge of GCP and clinical data principles.
• Analytical and problem-solving capabilities.
• Attention to detail and documentation skills.
• Ability to work cross-functionally and manage multiple priorities in a fast-paced environment.
• Experience in utilizing EDC systems, data analytics, visualization tools, monitoring and/or surveillance methodologies (e.g., QTLs, KRIs, signal detection, and interrogation).
• Knowledge of clinical data and vendor data reconciliation.
• Experience executing user acceptance testing and validation of outputs. 
• Effective cross-functional communication skills.

We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

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.