Central Report Reviewer

Description

Central Report Reviewer

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

• 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.

Qualifications

What we’re looking for

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• • Should have 5+ years in Clinical Operations in Global CRO or Global Pharma.
  • Should have 3+ years of CRA experience with on-site activities and PSSV, SIV, IMV, COV reports writing
  • Having experience in phases II-III multicenter studies is preferred
  • Must have worked on PSSV, SIV, IMV, COV reports review 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 HealthOver 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.

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.