Central Report Reviewer

Syneos Health, Inc.; Maharashtra; À distance; INR 600 000 - 1 000 000; Plein temps

Résumé du poste

Syneos Health, Inc. is hiring a Central Report Reviewer to oversee the execution of central report reviews across Phase I–IV trials.

You will ensure adherence to protocol, ICH-GCP, and country regulations, while safeguarding patient safety and data integrity. The role involves reviewing site and central monitoring documentation, communicating issues to the Clinical Trial Manager, and supporting CTM activities.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Capable of working in an international environment skills.
• Previous clinical trial experience in site management and clinical preferred.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.

Responsabilités

• Execute Central Report Review activities on the assigned study, ensuring protocol and GCP compliance.
• Review monitoring documentation and CTMS for accuracy and timelines.
• Assess patient safety and data integrity risks at investigator sites and escalate as needed.
• Document observations and action items; support CTM with deviations and trends.
• Participate in project meetings and trainings to maintain current project status knowledge.

Connaissances

Attention to detail

Problem solving

Communication skills

Interpersonal skills

Critical thinking

Team collaboration

Formation

Bachelor’s degree or RN

Outils

CTMS

Description du poste

Updated: Today
Location: Remote, MH, India
Job ID:25109862

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

Responsible for execution of Central Report Review activities on the study based on the

• Monitoring strategy defined, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• May support development of annotated visit reports such as PSV, SIV, IMV, COV & SCAN
• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations/special Sponsor’s requirements and pharmacovigilance issues documented in the report. Immediately communicates/escalates serious issues to Clinical Trial Manager/Project Manager
• Documents observations noted during reviews and ensures protocol deviations or action items are reported as necessary in appropriate systems for action by CRA/CM or other functional team members.
• May assesses CRA/CM report quality, risks, and trends as well as operational performance and summarizes the findings for CTM review and action planning.
• Participates in clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements. Involves in regular project discussion and email correspondence to maintain the most up-to-date project status knowledge and progression.

Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.

• May support in CTM activities such as Protocol Deviation management, Action Items management, etc.

Additional Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Capable of working in an international environment skills
• Previous clinical trial experience in site management and clinical preferred
• Preferred experience in study management (as Lead CRA of equivalent)
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good documentation habits and skills, strong attention to detail
• Must demonstrate good computer skills and the ability to learn new technologies
• Good communication and interpersonal skills among project team and with sites
• Demonstrates critical thinking and problem solving techniques to determine the cause and appropriate solution in the identification of issues

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.

Summary

The Central Report Reviewer (CRR) has the overall responsibility for execution of Central Report Reviewactivities on an assigned study. The Central Report Reviewer performs report reviews and approvesreports for Phase I-IV clinical research studies to assess compliance with the protocol, ICH-GCP, and/orall applicable local and federal regulatory requirements as well as ensure patient safety and data integrityusing a variety of technologies. In addition, the CRR ensures that any trip report fully reflects conductedmonitoring activity, and report finalization timelines are compliant with SOP, regulatory guidelines andMonitoring Plan. Will use analytical skills, critical thinking, data and information analysis, research andcommunication to problem solve. Performs all tasks routinely and independently

Description

Central Report Reviewer

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.
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

Responsible for execution of Central Report Review activities on the study based on the

• Monitoring strategy defined, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• May support development of annotated visit reports such as PSV, SIV, IMV, COV & SCAN
• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations/special Sponsor’s requirements and pharmacovigilance issues documented in the report. Immediately communicates/escalates serious issues to Clinical Trial Manager/Project Manager
• Documents observations noted during reviews and ensures protocol deviations or action items are reported as necessary in appropriate systems for action by CRA/CM or other functional team members.
• May assesses CRA/CM report quality, risks, and trends as well as operational performance and summarizes the findings for CTM review and action planning.
• Participates in clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements. Involves in regular project discussion and email correspondence to maintain the most up-to-date project status knowledge and progression.

Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.

• May support in CTM activities such as Protocol Deviation management, Action Items management, etc.

Additional Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Capable of working in an international environment skills
• Previous clinical trial experience in site management and clinical preferred
• Preferred experience in study management (as Lead CRA of equivalent)
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good documentation habits and skills, strong attention to detail
• Must demonstrate good computer skills and the ability to learn new technologies
• Good communication and interpersonal skills among project team and with sites
• Demonstrates critical thinking and problem solving techniques to determine the cause and appropriate solution in the identification of issues

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.

Summary

The Central Report Reviewer (CRR) has the overall responsibility for execution of Central Report Reviewactivities on an assigned study. The Central Report Reviewer performs report reviews and approvesreports for Phase I-IV clinical research studies to assess compliance with the protocol, ICH-GCP, and/orall applicable local and federal regulatory requirements as well as ensure patient safety and data integrityusing a variety of technologies. In addition, the CRR ensures that any trip report fully reflects conductedmonitoring activity, and report finalization timelines are compliant with SOP, regulatory guidelines andMonitoring Plan. Will use analytical skills, critical thinking, data and information analysis, research andcommunication to problem solve. Performs all tasks routinely and independently

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.