Single Sponsor Site Activation Specialist II (UK/Ireland Submissions) - Hybrid - 3 days in Maidenhead

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
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 deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

• Responsible for the quality deliverables at the country level; follows project requirements and applicablecountry rules, with moderate oversight from the SSU Country Manager.
• Works within the forecasted submission/approval timelines and ensures they are complied with andtracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines arenot reached: investigates and provides clear rationale for delays, provides support on contingency planto mitigate impact, and escalates the issue as soon as identified.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in atimely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country levelwhere assigned (submissions, essential document collection, communication to Competent Authoritiesand ECs, etc.).
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per CompanySOP/Sponsor requirements.Responsible for one or more of the following functions at the country level:
• Local Submissions Specialist - Follows the project direction provided by the designated country startupadvisor (CSA) and SAM. May serve as a point of contact for the PM/SAM (or designee) during start-up on allocated projects. Complies and/or reviews essential document packages for site activation andmay also be involved in essential document collection from site. Prepares and submits Central ECApplications, Local EC Applications, RA Applications, and other local regulatory authorities or hospitalapproval submissions as required.
• Prepares ongoing submissions, amendments, and periodic notifications required by central and localEC and RA and other local regulatory authorities as needed within the country; includes safetynotifications as required by local rules, with moderate oversight from the SSU Country Manager.
• May act as liaison and facilitator between investigational sites and functional leads for related tasksand/or issues. Oversee site activation end to end process at country/ site level.
• Country Start-Up Advisor - Acts as Subject Matter Advisor for in-country performance within the SiteStart-Up. Supports country-level intelligence on start-up (SU) and clinical trial regulatory (CTR).Ensures that local country regulatory intelligence, as it pertains to the activities of the local SU and CTRteam, is maintained on the central repository, e.g., Competent Authority submissions, EC submissions,notifications to data protection authorities, notifications/applications to any other local/federal/nationalbody, and import/export license applications where these are obtained with RA applications. Inabsence of legal advisor or dedicated subject matter may provide support for data protection at thecountry and provide guidance at a country level on data protection statements that need to be includedon those documents which the Sponsor has contracted to the Company start-up group to adapt to localrequirements. This may include the Principal Investigator/Informed Consent and the ConfidentialDisclosure Agreement/contract template. Provides input in local SOPs and WI. Supports the creationof internal training materials on local legislation requirements. Provides input to the team to assist withEC or CA issue resolution at the country level.
• Local Site ID and Feasibility Support – Provides support with site selection lead and PM/SAM to ensurethat the appropriate sites are selected for individual studies based on the requirements of the clinicaltrial.

Qualifications:

- Bachelor's Degree required, degree in health care or scientific field preferred
- A minimum of 1-2 years of clinical research experience and preferably 1+ years of study start up management experience for the designated region.
- Experience working with remote/virtual teams
- Good analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives.
- Good interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.
-Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast paced environment
- Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment

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.