Site Activation Partner

Description

Site Activation Partner - FSP (Remote)

**Come discover what our 25,000+ employees already know**: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

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 every 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.

Job responsibilities
- Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation
- Register investigator sites and sponsor stakeholders in sponsor 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 start-up 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 supplyshipment information, payment information, IRB submission and status
- Take the lead to resolve issues or concerns and timely escalation of Site issues 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.
- Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements
- Coordinate the timely communication, documentation and responses between sponsor and Central Ethics committee to bring clinical study to approval (country dependent)
- Support investigators sites with local IRB workflow from preparation, submission through approval
- Assist with preparation, handling and distribution of non-Clinical 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 Site Operations/CRO monitor access to eISF prior to SIV

**Additional Responsibilities**:

- A good understanding of the Site Activation requirements and processes within the country/region and be able to learn and potentially implement in more than one (1) country
- May be assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multi-country
- May be assigned as an SME on a system and/or process, and represent the SAP function as applicable
- May represent the SAP role on global initiatives
- Able to act as an SME on projects and initiatives, as requested
- Support the mentoring of new hires on processes/ systems

**Qualifications**:
What we’re looking for
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Must have industry experience (CRO, Pharma, Biotech) within the SSU and Site Activation space
- Must demonstrate good computer skills and be able to embrace new technologies.Proficiency in navigation within CTMS systems and Data Platforms for projects required
- Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected

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.

**Additional Information**:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Co