Sponsor Dedicated Global Clinical Trial Manager II (Oncology) Fully home based from any EU country
Updated: April 16, 2025
Location: Italy-Europe - ITA-Home-Based
Job ID:25003136
Sponsor Dedicated Clinical Trial Manager II
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
The CTM's are responsible for supporting the Senior PM's in the global implementation of our clients studies from the receipt of the protocol concept to final CSR.
STUDY OVERSIGHT
Request and ensure delivery of Pharmacovigilance database set-up, training slides, and SAE forms.
Insurance Certificates Requests to CTL (help to complete form and send email request).
Develop Master Informed Consent Form(s) and management of all template updates.
Country and Site specific ICF Review.
Collect CV and 1572 for one site as well as Master ICF and TORO for filing with IND/regulatory application.
Maintain updated Trial Master File (TMF) through ongoing filing of study documents and ensure Audit readiness (includes paper or eTMF). Ensure processes are developed for ongoing QC of TMF.
Create and get approval of Subject Reminder Cards and dosing diaries, as required
Centerwatch.com: Submit initial study posting and maintain consistent with clinicaltrials.gov.
Sample Management: Coordinate PK, PD, or other sample logistics and tracking (i.e. biopsies).
Maintenance of Study Logs as appropriate (Patient Registration log, Question & Answer Log, Sample log, etc.).
CSR Appendices: Provide information for CSR Appendices, such as those referenced below.
• 16.1.3 List of IECs or IRBs and Representative Written Information for Subjects and Sample Consent Forms.
• 16.1.4 List and Description of Investigators and Other Important Participants in the Study.
• 16.1.10 Documentation of Inter-laboratory Standardization Methods and Quality Assurance Procedures.
Project Planning
Develop/Review Study Plans, Manuals and tools, as applicable.
Manage Vendor specification development/review. Participate in User Acceptance Testing (UAT), as applicable. (e.g. IRT, EDC, ePRO).
Review of monitoring reports.
Site Management
User Management Tool (UMT) oversight and report review.
Site visits, as required (i.e. CRA observation, recruitment booster visits, site engagement, etc.).
Draft and ensure review and approval of study newsletters and other correspondence prior to approval for release.
Database cuts/locks: Help follow up with sites for data entry and query resolution, as needed.
Vendor Management
Investigator Meeting(s): Work with Meeting Planner and internal attendees to coordinate slide presentations, planning of slide review meetings, and other meeting details.
Vendor management (day-to-day interactions).
Help ensure Vendor equipment return.
Qualifications
What we’re looking for
• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Demonstrated ability to lead and align teams in the achievement of project milestones
• Previous CTM experience gained from a CRO or Pharma company.
• Demonstrated expertise in site management and monitoring (clinical or central)
• Global experience is needed, plus Oncology exp.
• Demonstrates understanding of clinical trial management financial principles and budget management
• 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
• Strong conflict resolution skills
• Demonstrated 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
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
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.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to:
Syneos Health is a leading 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. We support a diverse, equitable and inclusive culture.
Phone: 919 876 9300
Fax: 919 876 9360
Toll-Free: 866 462 7373
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: jobs@syneoshealth.com One of our staff members will work with you to provide alternate means to submit your application.
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