Country Start-up Specialist - Maintenance

1001 Syneos Health, LLC; Illinois; Hybride; USD 56 000 - 96 000; Plein temps

Avantages offerts par ce poste

Health benefits

Company car or car allowance

Company match 401k

Employee Stock Purchase Plan

Commissions/bonus

Flexible PTO

Résumé du poste

Syneos Health in Illinois seeks a Country Start-Up Specialist - Maintenance to manage country-level start-up tasks, regulatory submissions, and center activation for clinical trials. You will ensure SOP compliance, track timelines, and coordinate with EC/RA authorities while supporting continuous improvement of SSU processes.

Responsibilities include preparing local EC and RA submissions, maintaining TMF documents, and acting as a liaison between sites and line managers.

Qualifications

• Experience in Clinical Research, Study Start-Up, Regulatory Affairs, Clinical Operations, or related functions.
• Strong project management and organizational skills.
• Strong written and verbal communication and interpersonal skills.

Responsabilités

• Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager.
• Works within forecasted submission/approval timelines and tracks milestones in real time; investigates delays and provides contingency plans.
• Monitors basic financial aspects of the project and hours/tasks per contract; escalates discrepancies.
• Reviews SOPs and Work Instructions; keeps training records updated and ensures timesheet compliance.
• Supports continuous improvement of SSU quality at the country level (submissions, essential document collection, communication to authorities).
• Prepare and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory submissions.
• Oversee site activation end to end process at country/site level.
• Supports country-level intelligence on start-up (SU) and clinical trial regulatory (CTR).
• Ensures local regulatory intelligence is maintained in the central repository.

Connaissances

Clinical Research Start-Up

Regulatory Affairs

Project Management

Cross-functional Collaboration

Excellent Communication

Description du poste

Country Start-up Specialist - Maintenance 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 aapplicable country rules with moderate oversight from the SSU Country Manager.
• Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached: investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely 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 level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
• Responsible for the Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (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 and may also be involved in essential document collection from site.
• Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
• Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country; includes safety notifications 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 tasks and/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 Site Start-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 CTR team, 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/national body, and import/export license applications where these are obtained with RA applications.
• In absence of legal advisor or dedicated subject matter may provide support for data protection at the country and provide guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements.
• This may include the Principal Investigator/Informed Consent and the Confidential Disclosure Agreement/contract template.
• Provides input in local SOPs and WI.
• Supports the creation of internal training materials on local legislation requirements.
• Provides input to the team to assist with EC or CA issue resolution at the country level.
• Local Site ID and Feasibility Support – Provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
• May be asked to perform: Local Investigator Contract and Budget Negotiator – Provides support to SAM to agree on country template contract and budget.
• Produces site-specific contracts from country template.
• Provide support in submissions for proposed contract and budget for site.
• Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SAM with Sponsor until resolution of issues and contract execution.
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.

Qualifications

• Experience in Clinical Research, Study Start-Up, Regulatory Affairs, Clinical Operations, or related functions.
• Demonstrated experience managing country start-up activities, including regulatory and ethics committee submissions, essential document collection, and study activation processes.
• Experience supporting study maintenance activities, including protocol amendments, continuing reviews, safety submissions, renewals, and ongoing regulatory compliance.
• Strong understanding of ICH-GCP guidelines and local regulatory requirements.
• Experience working with multiple stakeholders, including sponsors, CROs, investigator sites, and regulatory authorities.
• Strong project management and organizational skills
• Strong written and verbal communication and interpersonal skills.
• Coordinate country start-up activities from study award through site activation.
• Prepare and submit regulatory and ethics committee packages to support study initiation.
• Track country and site activation timelines, ensuring milestones are achieved according to project plans.
• Manage ongoing study maintenance activities, including amendments, renewals, annual reports, and essential document updates.
• Support sites throughout the lifecycle of the study, ensuring continuous regulatory compliance and operational readiness.

Benefits

• company car or car allowance
• Health benefits to include Medical, Dental and Vision
• Company match 401k
• eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• 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.

Salary Range

Salary Range: $56,400.00 - $95,900.00 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.

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.

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.