FSP Site Activation Specialist II (Sydney/ Melbourne/ Brisbane- Home based)

Full job description
Description

FSP Site Activation Specialist II (Sydney/ Melbourne/ Brisbane- Home based)
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.
Job Responsibilities

Manage and execute the site identification process in accordance with regulations, SOPs, and project requirements, ensuring timely and accurate completion of all tasks
Complete and negotiate site confidentiality agreements (CDAs) and site information forms (SIFs) with sites, ensuring compliance with legal and regulatory requirements
Maintain, review, and report on site performance metrics, identifying areas for improvement and implementing corrective actions as needed
Serve as the primary point of contact for investigative sites, providing support and guidance throughout the site identification process
Track the completion of site identification for sites, ensuring all necessary documentation is collected and maintained in accordance with SOPs and project requirements
Contribute to the design, implementation, and delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education and experience
Utilize practical knowledge of the professional area to manage defined components of projects or processes within area of responsibility, ensuring alignment with overall project goals and objectives
Direct the work of lower level professionals or manage processes and programs, providing guidance and support to ensure successful completion of tasks
Collaborate with cross-functional teams to ensure seamless integration of site identification activities with other project components
Stay current with industry trends and best practices, incorporating new knowledge and skills into daily work to enhance overall performance
Qualifications:

Bachelor's degree in a relevant field or equivalent experience
Minimum of 3 years of experience in site start-up or site identification
Strong understanding of regulations, SOPs, and project requirements related to site identification
Excellent negotiation and communication skills
Ability to manage multiple tasks and projects simultaneously
Detail-oriented with strong organizational skills
Certifications:

Certification in clinical research or related field preferred
Training in Good Clinical Practice (GCP) and other relevant regulations
Necessary Skills:

Proficiency in site confidentiality agreements (CDAs) and site information forms (SIFs)
Ability to maintain, review, and report on site performance metrics
Strong problem-solving and analytical skills
Effective communication and interpersonal skills
Ability to work independently and as part of a team
Proficiency in relevant software and tools
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.

http://www.syneoshealth.com

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.

Summary

Roles within the Site Start-Up/Site ID job family at the P21 level are responsible for managing and executing the site identification process in accordance with regulations, SOPs, and project requirements. These roles involve completing and negotiating site confidentiality agreements (CDAs) and site information forms (SIFs) with sites, maintaining, reviewing, and reporting on site performance metrics, serving as the primary point of contact for investigative sites, and tracking the completion of site identification for sites.Impact and ContributionIndividuals in these roles are established and productive contributors who may manage defined components of projects or processes within their area of responsibility. They utilize their practical knowledge of the professional area, typically obtained through education combined with experience, to contribute to the design, implementation, or delivery of processes, programs, and policies. Their work ensures that site identification processes are completed efficiently and effectively, supporting the overall success of clinical trials and research projects.Core Focus•Managing and executing the site identification process in accordance with regulations, SOPs, and project requirements•Completing and negotiating site confidentiality agreements (CDAs) and site information forms (SIFs) with sites•Maintaining, reviewing, and reporting on site performance metrics•Serving as the primary point of contact for investigative sites•Tracking the completion of site identification for sites
 

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