The Area SSU Lead is responsible and accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned pipeline and Global Medical Affairs clinical studies within area. The role reports into the Area SSU Head and serves as a single point of accountability across the area for the delivery and execution of the site start up and maintenance activities for the assigned studies within the area
Note: Area SSU Leads will report in to the Area SSU Head but have an operational reporting line to Global SSU Leads
Primary responsibilities include but are not limited to:
- overseeing and proactively driving activities of Country SSU Specialists for assigned trials.
- proactively identifying and communicating issues impacting delivery and providing proposed solutions.
-working with Area and Country leadership to identify training needs of the country start-up specialists and standardizing and facilitating training solutions for Start-up specialists within area.
- Accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned clinical studies within area
-working collaboratively with key stakeholders and establishing country/site activation plans including risk assessments and mitigation planning for the countries and sites within their area
-driving start up activities including timely site selection and activation, EC submissions, document collection, and query responses,
- providing area start up updates and metrics to Area Director, and Global SSU Leads
- running area start up meetings and driving priority action items between meetings
- collaborating with Global Site Contracting & Purchasing and Supplier Management, CTS and Regulatory Affairs, Global SSU Leads, Global CSM Leads, Country COMs and Country SSU Specialists to assure alignment between contract execution, CA and EC submission activities, site training visits and site activation planning
- leading quality management through risk-based thinking for the assigned studies
- driving standardization in area start up process and training, including sharing of best practices and lessons learned
- maintaining SSU performance metrics and KPIs for assigned studies
- ensuring audit/inspection readiness
- ensuring maintenance of intelligence database and Vault EDLs for countries and sites within their area
- ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines
- participating in process improvement initiatives as required
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 all 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.
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.
As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.
This job excludes CO applicants
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.
Primary Location: North America - US Home-Based
Job: Clinical Project Management
Travel: Yes, 25 % of the Time
Employee Status: Regular