Medical Scientist

5264 Syneos Health India Private Limited; India; Remote; INR 900,000 - 1,300,000; Full time

Job summary

Syneos Health is seeking a Medical Scientist to serve as a Clinical Data Reviewer, identifying data errors by conducting thorough data reviews per DRP and raising/closing queries. You will monitor data quality and collaborate with sponsors, CRAs, and study teams to ensure accuracy and audit readiness.

In this role you will work closely with Clinical Scientists, Data Management and Clinical Operations to support data capture, timely resolution of issues, and high-quality deliverables across study

Qualifications

• Clinical data review experience (per DRP) and data quality focus.

Responsibilities

• Serve as Clinical Data Reviewer and identify data errors by performing data review per DRP.
• Issue clinical data queries and ensure timely follow-up with site responses and updates in the EDC.
• Collaborate with Clinical Scientists, Data Management and Clinical Operations to execute data reviews and deliverables.

Tools

EDC

Job description

Medical Scientist 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.

Job Responsibilities

Serves as a Clinical Data Reviewer and identify any errors in data by performing data review per DRP and issuing/closing queries. Performs ongoing review of clinical/medical aspects of the study participant data and documents (escalates to Syneos/client Clinical Scientist and/or Study Medical Director, as appropriate) Examples include but not limited to: Patient eligibility, diagnosis, medical history and prior treatments, study drug administration, AE/SAE/AESI, con meds, IP dose titration and/or compliance, safety labs, efficacy assessments (only if specified), EOT, EOS, survival, coding, etc. Issues clinical data queries and ensure timely follow up following site responses as to whether the queries are appropriately addressed, and updates in EDC done, if applicable, by either closing out the queries or re-querying, as applicable and with consultation with the clinical team as needed. Communicates to Sponsor any data training needs or concerns for CRAs, sites, etc Provides clinical data review project management status and is viewed as an expert in data clinical/medical review and cleaning. Ensures data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance. May assist in review and contribute to data capture requirements guidance in line with protocol and reporting requirements. Monitors site data entry performance and provide sponsor study team information to assist in identifying root causes of data issues and implementing remedial actions. Ensures timely follow-up and resolution of clinical data related compliance issues. Continuously assess opportunities to improve efficiency of tasks and quality of data deliverables. May contribute to EDC completion training. May exceptionally participate in clinical data review meetings and/or prepare slides for meetings May be involved in preparing or review material for and in exceptional cases may present in data dissemination meetings. Will collaborate closely with several Syneos/client functions mainly Clinical Scientists, Study Medical Directors, Data Management and Clinical Operations to execute clinical data reviews and activities during study conduct, including prior to data cuts for snapshots, interim analysis, DSUR, IBs, regulatory requests, study site close-outs and final DBL. May be involved in QC review of patient narratives.

Get to know Syneos Health

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.

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.