Job Description

Central Monitor II or Senior Serbia - experience in reviewing clinical data needed

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

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Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.

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Reviews patient data listings and visualizations via analytical dashboards and/or reports to confirm eligibility, identify protocol deviations, patient safety concerns, data integrity issues and illogical/inaccurate/missing data.

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Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

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Immediately communicates/escalates serious issues to the project team and with guidance develops action plans.

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Documents observations noted during reviews and writes queries, protocol deviations or action items as necessary in appropriate systems for action by sites, CRAs or other functional team members.

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Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

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Accesses vendor systems or reports to verify the IP has been dispensed and administered to subjects/patients according to the protocol, that laboratory and other procedures have been performed, that eTMF data is current and complete.

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Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan.

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For assigned activities, understands project scope, budgets, and timelines; manages patient- and site-level activities to ensure project objectives, deliverables and timelines are met.

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Must be able to quickly adapt, with the oversight of the Lead CRA/LCMDA, to changing priorities to achieve goals/targets.

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Prepares for and attends Investigator Meetings and/or sponsor meetings. Participates in project staff meetings, as applicable and attends clinical training sessions according to the project specific requirements.

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.