Site Activation Specialist

Description

Site Activation Specialist

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.

Join our team as a Site Activation Specialist and play a key role in driving the successful launch of clinical trials in North America. You'll manage regulatory submissions, oversee site activation, and ensure compliance with local regulations and company standards. With the opportunity to collaborate closely with investigational sites and project teams, you'll be at the forefront of ensuring smooth and efficient site activation for patient enrollment. You will also experience ways to develop and enhance leadership skills by mentoring junior team members and/ or provide oversight of country delivery.

You will be joining a growth-oriented team led by individuals who have all advanced from the Site Activation Specialist role, each bringing many years of experience at Syneos in Site Start-Up. Our management team's longevity speaks to a culture built on collaboration, mentorship, and support. This is a place where colleagues genuinely help one another succeed, offering endless opportunities for personal and professional growth through continuous learning and development initiatives.

If you're passionate about making an impact and thriving in a dynamic, fast-paced environment, while looking to advance your career within a team that values both individual growth and collective success, this is the perfect environment for you!

Job Responsibilities

General:

* Accountable for delivering high-quality results at the country level, ensuring compliance with project requirements and applicable country-specific regulations, with minimal oversight from the SSU Country Manager.

* Responsible for forecasting submission/approval timelines, ensuring compliance, and tracking milestone progress in real-time via the SSU tracking system. If timelines are not met, analyze data, provide a clear rationale for delays, and propose contingency plans to mitigate impact.

* Oversee the financial aspects of the project, ensuring the number of hours/tasks aligns with the contract, and promptly escalate any discrepancies.

* Ensure adherence to Standard Operating Procedures (SOPs) and Work Instructions (WIs), keep training records up to date, and ensure timesheet compliance.

* Submit all relevant documents to the Trial Master File (TMF) according to company SOP/Sponsor requirements.

* Drive continuous improvement in all Site Start-Up (SSU) components at the country level, including submissions, essential document collection, and communication with Competent Authorities (CAs) and Ethics Committees (ECs).

* Travel up to 25%

Key Functions at the Country Level:

* Local Submissions:

o Follow project direction and leverage expertise from the designated country point of contact and PM/SAM.

o Compile and/or review essential document packages for site activation and assist with document collection from sites.

o Prepare and submit Central EC Applications, Local EC Applications, RA Applications (if applicable), and other local regulatory approvals as required.

o Manage ongoing submissions, amendments, and notifications to central and local ECs, RAs, and other regulatory authorities, including safety notifications, with minimal oversight.

* Country Oversight:

o Serve as the Subject Matter Expert for in-country Site Start-Up (SSU) performance.

o Ensure local country regulatory intelligence is maintained in a central repository, including Competent Authority submissions, EC submissions, and other regulatory requirements.

o Provide data protection guidance at the country level for documents such as Informed Consent and Confidential Disclosure Agreements.

o Contribute to local SOPs/WIs and assist in creating internal training materials based on local legislation requirements.

o Resolve issues with EC or CA at the country level, ensuring compliance and effective communication.

* Local Site ID and Feasibility Support:

o Assist the site selection lead and PM/SAM in identifying appropriate sites for clinical trials based on study requirements.

* Mentoring and Guidance:

o Mentor junior team members by advising on administrative policies, technical challenges, priorities, and methods.

o Provide constructive feedback and foster growth within the team.

Country Point of Contact Responsibilities:

* Act as the primary point of contact for country participation, overseeing the site start-up process and ensuring a smooth transition to site activation and First Patient In (FPI).

* Assist SAM in analyzing country and site metrics to ensure project deliverables align with sponsor projections for FPI, improving overall project efficiency and performance.

* Lead and/or support operational site-level planning and ensure compliance with document submissions to the Trial Master File (TMF) in line with company and sponsor requirements.

Qualifications

What We're Looking For:

* Education: Bachelor's Degree required.

* Experience:

o Strong understanding of the clinical trial process across Phases II-IV, ICH GCP guidelines, and clinical protocols.

o In-depth knowledge of clinical trial start-up processes.

o Proven experience in project management within a fast-paced environment.

* Skills:

o Exceptional organizational skills with the ability to manage multiple projects simultaneously.

o Excellent communication, presentation, and interpersonal skills.

o Strong negotiation and problem-solving skills.

o Ability to provide clear, actionable feedback and guidance to peers.

o Solid vendor management skills and ability to work collaboratively with external partners.

* Leadership:

o Demonstrated ability to mentor, lead, and motivate junior staff.

o Ability to contribute to training and quality assurance initiatives within the SSU team.

o Proactive in contributing to the creation and updating of local SOPs/WIs and other internal documentation.

As a Site Activation Specialist at Syneos Health, you'll leverage your experience while we provide the mentorship and opportunities to further elevate your leadership and project management skills. Join a collaborative environment where your contributions are valued, and together, we'll drive success and innovation. Apply now and take your career to the next level with us!

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.

AtSyneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

The annual base salary for this position ranges from $50,760 to $95,900. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.