Description
For one of our FSP partnerships we are currently recruiting for a
Site Monitoring Lead (Clinical Trial Manager) to join the team.
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.
As part of Clinical Development & Operations (CD&O) team the Site Monitoring Lead (SML) is a key member of global Clinical Trial Team nominated to a specific trial within the Evidence Network. SMLs are accountable for authoring the monitoring risk assessments and plans, ensuring sponsor oversight, trend analysis, signal detection and delivery of their assigned trial(s) in close collaboration with the CRO partner to ensure delivery of the company's pipeline through accurate planning and efficient execution of Site Monitoring in trials that bring speed & value to participating subjects and sites.
The SML provides Site Monitoring expertise to and consults the Trial Team, leads and oversees the implementation of the Site Monitoring & Oversight approach and activities as part of overall clinical trial quality management. SML contributes to the overall success and delivery of their assigned clinical trial(s)in all R/OPUs according to defined milestones and key performance indicators (e.g. Medicine Excellence KPIs - MedEx).
The SML is accountable for managing the trial level planning, implementation, issue management, and oversight of the Site Monitoring activities of a trial as assigned, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, company sponsor obligations, ICH-GCP and applicable regulations and ensure inspection readiness at all times.
Qualifications
What we’re looking for
- University or comparable degree in life sciences or related field OR several years of equivalent professional education may be acceptable if complemented by solid knowledge in and experience with Site Monitoring and Site Management processes and accountabilities
- Proven track-record of multiple years of site monitoring and management experience covering sufficient & significant experience and knowledge in all stages of clinical trials (i.e. site selection, initiation, conduct and close-out) in different therapeutic areas from early to late phases of clinical development.
- In-depth knowledge of International Conference on Harmonization (ICH) regulations and Good Clinical Practice (GCP) and understanding of legal/regulatory environment as it pertains to major regulatory authorities and relevant directives/regulations.
- Understanding of major regulations (US FDA, EMA and PMDA).
- Cross geographical experience. Working in multi-cultural environment; strong understanding of corporate culture and cross-cultural dynamics.
- Demonstrated competencies in Agility, Accountability, and Intrapreneurship: fast decision-making, flexibility, ownership, outcome-based thinking, results orientation, and smart risk-taking.
- Solid project management and internal/external communication skills.
- Language: Fluent in English (written and spoken)
- Strong Communication Skills: Demonstrates Accountability Agility Intrapreneurship (AAI) approach and skills in complex cross-functional matrix structures of the trial and extended team. Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. Demonstrates active listening skills and cultural awareness.
- Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across all Site Monitoring aspects in clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors.
- Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations, confidently coordinating and overseeing teams. Demonstrates leadership behaviors of supporting, connecting and empowering teams, setting priorities.
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.
