Adresse
Forme de travail
Un salaireSyneos 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.
The Site Management Associate II (SMA II) is responsible for Site Management activities for assigned
sites. For site-based studies, the SMA II is the primary contact for the site and is responsible for providing
site support throughout the full study lifecycle from site identification through closeout. The SMA II
provides support, training and customer service to physicians and site staff to speed performance and
alleviate site burden for real world research studies.
JOB RESPONSIBILITIES
Perform Site Management activities in compliance with the Company and Sponsor (if applicable)
Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Assure compliance with local regulations and appropriate guidance depending on assigned study
design / classification. May include Good Pharmacoepidemiology Practices (GPP) and/or
International Conference on Harmonization - Good Clinical Practice (ICH-GCP).
Conduct Site Management activities as per agreed Scope of Work (SoW), Site Management Pl an
(SMP) and relevant guidelines.
o Site identification - may contact sites to obtain interest in study participation, confirm
contact details, retrieve documents for consideration, etc.
o Site Qualification - Ensures selection of appropriate sites for assigned studies.
o Site Start-Up - With minimal supervision, ability to perform activities for assigned sites
working with study start-up and regulatory.
o Conduct of all remote and on-site monitoring activities through all study stages.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the
investigator/physician site is aware of the requirement of archiving essential documents in
accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs,
and other required project documents as per SOPs and SMP, within required timelines. Supports
subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems
as required to track all observations, ongoing status and assigned action items to resolution.
Demonstrates diligence in protecting the confidentiality of each subject/patient.
Assigned sites data review, assisting with data query resolution and missing data follow-up (only
as applicable). Review data using data trend reports and knowledge of site practices. Ensure the
resolution of data queries within agreed timelines. Utilize available hardware and software to
support effective study data collection and review.
Maintain effective, accurate and timely communication with site staff and project team, and ensure
appropriate issue escalation and resolution as per SOPs with a focus on issue prevention.
Maintains clinical tracking and management systems.
Site Management Associate II SH1322 01Nov2019
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Ensure all assigned sites are trained and compliant with requirements of the study protocol,
informed consent process, data collection requirements/data collection tools and safety reporting.
Provides guidance at the site and project level towards audit readiness standards and supports
preparation for audit and required follow-up actions.
Prepare for, attend and participate in Investigator Meetings and/or sponsor face-to-face meetings.
As required, collaborate and build relationships with Sponsor affiliates, medical science liaisons,
and local country sponsor staff.
For assigned activities, understands project scope, budgets, and timelines; manages site-level
activities / communication to ensure project objectives, deliverables and timelines are met. Must
be able to quickly adapt, with the oversight of the Clinical Operations Lead or designee, to
changing priorities to achieve goals / targets.
Identify and communicate out of scope activities to Clinical Operations Lead.
Attend, contribute to and present at study and department meetings.
Qualifications
What we’re looking for
BA/BS degree in science/health care field or nursing degree or equivalent combined
education and experience.
Must be proficient in Microsoft Office Suite (Word, Excel, and PowerPoint), email/voicemail,
and Clinical Trial Management and EDC systems.
Previous Site Management (in-house, on-site, Study Coordinator) or equivalent experience.
Excellent communication, time management, organizational, documentation and customer
service skills.
Knowledge of local requirements for Real World Late Phase study designs as well as Real
World Research and relevant regulations including GPP.
Excellent customer focus (internal and external) and able to interact professionally with a
client organization and study site.
Willingness to work within a team-oriented environment. Ability to work in a “virtual” team
setting as well as work independently, seeking guidance as appropriate.
Ability to handle multiple tasks (across multiple studies as necessary) and prioritize
accordingly to achieve study timelines. Sound problem solving and analytical skills.
Excellent command of written and spoken local language, if not English, as well as English
required.
Ability to develop good working relationships via oral communication and good phone
etiquette.
Ability to travel up to 60% on a regular basis depending on assignments and study phase.
Site Management Associate II SH1322 01Nov2019
This document
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.
