Description
Site Activation Partner I - II
(CMA) with local or global experience in regulatory start up /fluent English -assigned to client - Chile/Colombia/Guatemala or Peru
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success.
We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
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.
Summary
The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and the client standards.
Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs the Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and the client standards.
Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs
Job Responsibilities
- Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation
- Register investigator sites and client stakeholders in client registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready
- Work directly and interact with investigator sites to confirm readiness for site startup by reviewing study site profile ready in SIP or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts,
clinical supply shipment information, payment information, IRB submission and status
- Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable
- May support the Informed consent customization (administrative details) where applicable
- Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
- Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
- Take the Lead, initiate and coordinates activities related to compilation of high-quality IRB/EC package and ensure timely submission to approval (Central and or Local and in countries where applicable), and other committees as per country requirements
- Collaborate with in-country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required
- Coordinate the timely communication, documentation and responses between the client and Central Ethics committee to bring clinical study to approval (country dependent)
- Assist with preparation, handling and distribution of nonClinical Trial Supplies and maintenance of tracking information as needed
- Collaborate with the Study Team on the development and readiness of sites eISF when utilized and act as primary point of contact for the sites and manage the Sit
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