Location
Europe | United Kingdom
Job description
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
Job responsibilities
Global Study Management
• Overall global main point of contact for the overall study, responsible for global project oversight.
Lead cross functional collaboration in the development of study documents, including but not limited to protocols, Informed Consent Form (ICF) templates, regulatory agency reports, statistical analysis plans and study reports.
Contracts and Budgets
• Develop and manage the budget for assigned projects (i.e., accruals, forecasting, and life of study planning).
• Create and update study forecast in available application.
• Create the template site budget and cost negotiation parameters to ensure compliance with overall study budget.
• Track monthly spend against plan.
• Provide Leadership with updates on budget(s) and variance(s) for assigned study(ies).
• Create the template site budget, cost negotiation parameters to ensure compliance with overall study budget and payment schedule template.
Metrics, Data Collection, and Data Quality
• Develop study metrics to monitor progress against deliverables.
• Accountable for the utilization of metrics and management reporting tools for efficient study execution.
• Responsible for participating in the design of EDC (Electronic Data Capture) data review tools, review of data quality review reports by assigned Study Team members, and resolution of identified issues.
• Participate in ongoing data review as outlined in data review plan.
• Contribute to development of data cleaning plans data quality checks, data management plan, and protocol deviation plan; develop data cleaning plans.
• Contribute to eCRF development, completion guidelines, user acceptance testing, data migration activities.
• Responsible for implementation of periodic data collection and cleaning initiatives.
• Collaborate with pharmacovigilance on the reconciliation of safety events in the clinical and safety databases.
• Provide medical monitor with safety event reports to identify trends and ensure medical monitor review completion
People Management and Development.
• Oversee and provide guidance to Trial Associates and Trial Specialists throughout the study conduct.
• Facilitate study training and professional development for direct reports and Study Team members.
• Confirm that all necessary training (departmental, study-specific, corporate) has been completed by direct reports.
• May manage and or participate in staff recruiting, hiring, and retention.
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Qualifications
What we’re looking for
• Bachelor’s degree in a related field or equivalent combination of education, training and experience.
• Solid experience as a Global Study Manager, or Global Project Manager within the industry, CRO or Pharma. Involvement from start up through to close-out. Experience of oversight on a global study/level and being the main point of contact across the study.
• English level: Required; includes communicating verbally and in writing on topics that are often technical and writing procedures or technical reports.
• Advanced Leadership, Strategic Thinking and Planning, Adaptability and Flexibility, Drug Development and Regulatory Environment, Therapeutic Area Knowledge skills.
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.
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Job tags
Salary
