Sponsor Dedicated Local Clinical Trial Manager II - UK and Ireland only
Sponsor Dedicated Local Clinical Trial Manager II - UK and Ireland only
Posted on :
03-02-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Title: Sponsor Dedicated Local Clinical Trial Manager II UK and Ireland only
Job Location: Leeds UK
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Description
Local Clinical Trial Manager II UK and Ireland only.
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 FullService 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 29000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
What we’re looking for
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.
Local Clinical Trial Manager II UK and Ireland only.
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 FullService 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 29000 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.
- The Local Study Manager (CTM II) is accountable for the strategic planning & management and performance of their assigned clinical trials from country allocation within feasibility process until study closure inclusive archiving including study timelines study budget and study conduct in accordance with SOPs and ICH/GCP and regulatory guidelines & directives.
- This includes the ability to identify and anticipate risks jeopardizing the trial performance and to develop and initiate countermeasures based on proposer planning and regular revision of the plans.
- The LSM is working crosscountries or crossclusters and covers satellite countries as well with a focus on UK and Ireland.
- The LSM acts on country/cluster level as the key strategic interface with internal and external stakeholders to develop implement maintain and improve operational processes to accelerate trial conduct in close collaboration with respective functions within Clinical Study Unit and other departments e.g. Medical Advisor Site Engagement Manager Strategic Start Up Manager Medical Science Liaisons.
- The LSM acts as Person of contact within a therapeutic area in terms of study management and conduct and leads a study team through change management efforts and by example.
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
- Experience in preparing local documents for submissions and local ICFs from master template.
- Experience with adapting local documents for submission according to local requirements.
- Demonstrated expertise in site management and monitoring (clinical or central).
- Preferred experience with riskbased monitoring.
- 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.
- May be required to attend face to face meetings in Reading.
- 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 73000 Sites and 675000 Trial patients.
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.
/jobs/view/933bb8700aca1f2a1255c0352a97016a
Employment Type
Full Time
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
