Description

Clinical Trial Manager I
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.
Job responsibilities

• Minimum 5 years' experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
• Capable of leading in a matrix environment, without direct reports
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution
• Recognise potential challenge within the protocol and operational aspects of the trial and escalate to manager as appropriate.
• Maintain a strong knowledge of the protocol to be able to answer standard operational questions from monitors, sites, and local internal personnel.
• In liaison with the global clinical team, assist in the development of local trial execution plan and timeline commitments for a country/cluster.
• Ensure that study start-up activities and any amendments are conducted and completed on time, including preparation of IRB/EC submission packages, working with regulatory affairs for Health Authorities submissions.
• Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents.
• Ensure sites are prepared for "Ready to Initiate Site" (checkpoint). Obtain written confirmation about availability of global documents.
• Ensure that all documentation in place for initial and subsequent drug release in collaboration with the local Qualified Person.
• Provide training as needed for monitors and any other activities that support site readiness to recruit.
• Ensure documentation of training (global/regional/local IM minutes, participants' lists, certificates, etc.) is archived appropriately.
• Drive the conduct of the trial, track and oversee progress and status.
• Ensure all operational aspects are on schedule.
• Oversee local clinical team activities to achieve trial timelines and quality execution according to standards and local and international regulations.
• Consistently read/review the content of all monitoring visit reports for the assigned trial to identify trends and issues.
• Appropriately escalate issues in a timely manner and ensure resolution.
• Communicate with field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics.
• Lead and chair local study team meetings, attend and participate in global clinical trial team meetings.
• Track trial budget with appropriate trial budget responsible in country. Oversee Trial Commitment Form (TCF) preparation and submission to Clinical Operations Manager (COM) in collaboration with the TCF specialist in the country.
• Keep oversight of country level data management activities, including timely resolution of data entry issues, screen failure reasons, discontinuation rates, patient profiles, and proactively identify data entry issues to mitigate queries.
• Accountable to keep reporting systems up to date: ClinAdmin, TMF, CREDI, etc.... throughout trial conduct
• Ensure that all trial closeout activities are performed, in close cooperation with field monitors and clinical trial head.
• Oversee local vendor selection and performance as needed. Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required
• Facilitate internal audits and Health Authority inspections as required.
• Support trial feasibility and Country Pharma Organisation (CPO) patient commitments in cooperation with the relevant line units: ensure two-way feedback on feasibility between global team and country.
• Coordinate and manage the site selection process in collaboration with the necessary line units
• Conduct local investigator meetings as needed

Qualifications

What we're looking for
• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
• Demonstrates ability to lead and align teams in the achievement of project milestones, demonstrates capability of working in an international environment.
• Demonstrates learning of basic clinical project financial principles
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills
• Good communication, presentation and interpersonal skills among project team and with sites
• Ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
• Moderate travel may be required, approximately 20%
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.