Country Start-Up Specialist -US

Syneos Health, Inc.; Illinois; Remote; USD 56,000 - 96,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits (Medical, Dental, Vis)

401k with company match

Bonus eligibility

Paid time off

Job summary

Syneos Health, Inc. is seeking a Country Start-Up Specialist (US) to lead country-level start-up activities, including regulatory submissions and essential document collection, ensuring timely site activation.

The role collaborates with CSA and SAM and supports EC/RA submissions and ongoing regulatory maintenance. Qualifications include a Bachelor’s degree and proven experience in clinical start-up, regulatory affairs, and project management.

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.
• Strong understanding of ICH-GCP guidelines and local regulatory requirements.
• Strong project management and organizational 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.

Responsibilities

• Ensure quality deliverables at country level and adherence to timelines.
• Monitor budgets and hours per contract; escalate discrepancies.
• Maintain SOP/WI compliance and training records.

Skills

Study Start-Up

Regulatory Affairs

Clinical Operations

Country start-up management

Education

Bachelor's degree

Job description

## Country Start-Up Specialist -USApply: Remote (Pre-Approved): USA-IL-Remote: Full time: Posted Today: 25114190Country Start-Up Specialist -USSyneos 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.* Bachelors degree required* 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. At Syneos 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. Salary Range:$56,400.00 - $95,900.00The 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.