Medical Scientist

Syneos Health; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Syneos Health is seeking a Medical Scientist to support the Clinical Solutions team by reviewing clinical data, identifying data discrepancies, and generating queries to maintain data integrity throughout study conduct. You will work with Clinical Scientists, Study Medical Directors, and Data Management to ensure timely resolution of data issues and audit readiness.

The role emphasizes collaboration, data quality assurance, and potential involvement in data capture guidance and dissemination

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)
• 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.

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. 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

• 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

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 con