Clinical Operation Lead / Clinical Trial Manager - single-sponsor - Belgium

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

For one of our single sponsor partnerships we are currently recruiting for a Clinical Operation Lead (CTM) to join the team.

• The Clinical Operations Leads provide supporting services to the Clinical Trial Manager/operational team in execution of the trial(s). These services include direct liaison with CROs and other ancillary vendors, as appropriate, to manage relevant trial(s) operational tasks.
• The Lead maintains effective communication with the project team through oral and written correspondence and status reports to ensure alignment with study timelines.
• The COL services include reviewing, developing, and writing clinical trial documents and manuals, including study manuals, laboratory or biomarker plans, and other supporting documents.
• Other services include the creation of the master ICF template and review/approve site changes (in consultation with legal, safety when warranted), plus update template for new risks and new amendments information.
• The COL services involve the feasibility and evaluation of investigative sites; working closely with the Clinical Trial Logistics group as well as coordinating and monitoring activities at investigational sites; review monitoring trip reports and supporting the monitoring organization.
• The COL services are to develop relationships with investigational sites and institutions to enhance conduct of the trial, while also act as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway.
• boards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required.
• Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.

Qualifications:

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience

• At least 3 years of relevant experience for the COL and at least 5 years of relevant experience for the Sr COL. 

• Demonstrated ability to lead and align teams in the achievement of project milestones

• Demonstrated capability of working in an international environment.

• Demonstrated expertise in site management and monitoring (clinical or central)

• TA experience; oncology early development, infection & auto immune disease is a big pre.

• Study start-up experience in different regions (global experience).

  Demonstrates understanding of clinical trial management financial principles and budget management

• These are global roles and experience in multiple regions is a requirement

• 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

We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

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.