Senior Central Monitor II
Come discover what our 25,000+ employees already know : work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason we improve patients’ lives around the world.
Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
SyneosHealthLife means we’re committed to our Total Self culture where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
We believe our success is a direct result of the people who are driving it you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you.
That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
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.
Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.
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.
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.
Immediately communicates / escalates serious issues to the project team and with guidance develops action plans.
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.
Maintains a working knowledge of ICH / GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs / processes.
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.
Documents completion of activities via tracking, reporting and / or other required project documents as per SOPs and Monitoring Plan.
For assigned activities, understands CM project scope, budgeted hours, and timelines; manages patient- and site-level activities assigned to CM in the clinical or central monitoring plans to ensure project objectives, deliverables and timelines are met.
Must be able to quickly adapt, with the oversight of the Lead CRA / Central Monitoring Lead (CML), to changing priorities to achieve goals / targets.
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.
Assesses site data quality, risks and trends as well as operational performance and summarizes the findings for CRA review and action planning.
Utilizes KRI dashboards, metrics and reporting systems and other analytical tools to synthesize data trends, issues, action items in a clear and concise presentation of the most relevant and actionable items for interpretation by CRAs and other functional roles assigned follow-up.
May review and approve reports, conduct training of junior CMs, and take on leadership roles within a project team as needed.
What we’re looking for
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
Knowledge of Good Clinical Practice / ICH E6 (R2) Guidelines and / or other applicable regulatory requirements.
Must demonstrate good computer skills and be able to embrace new technologies.
Mastery of MS Excel (sorting, filtering, calculating, pivoting).
Mastery of Analytical Data Visualization Tools (adjusting visualizations, selecting subsets of data to analyze, identification of trends and outliers).
Excellent verbal and written communication skills to relate to internal stakeholders.
Interact with CMDS for study deliverables.
Able to inform, influence and communicate cross-functionally.
Strong analytical skills.
Developed therapeutic expertise (expertise (Subject matter expert in at least 1 therapy area, ie. CNS or ONC).
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most.
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.
Asia Pacific - PHL-Philippines-Home-Based