As a Safety Coordinator, you will play a critical role in ensuring the safety of patients and employees in clinical trials.

Responsibilities:

• Coordinate safety activities across multiple sites and geographies
• Ensure compliance with regulatory requirements and company policies
• Collaborate with cross-functional teams to identify and mitigate safety risks
• Analyze and report safety data to stakeholders

Syneos Health is committed to building an inclusive culture where you can authentically be yourself.

The company offers various benefits, including career development and progression, supportive line management, technical and therapeutic area training, peer recognition, and total rewards program.

Job Data by YubHub.

Responsibilities:

• Maintain ownership of and manage contract process to ensure timely delivery and execution
• Negotiate and prepare contracts, budgets, and related documents for complex clinical trials
• Drive quarterly revenue targets through active workload management and prioritization
• Develop customer relationships and work independently with Project Managers and customers
• Update and maintain timely records in CRM and Contract Management System
• Follow all review processes and strive to deliver high-quality products

Requirements:

• BA/BS degree in Business Administration or Finance with 2-5 years of experience in budgeting, finance, proposal development, and/or contracts management
• Customer-centric, self-motivated, and proactive with excellent problem-solving skills and attention to detail
• Strong analytical skills and ability to perform multiple tasks simultaneously
• Knowledge of Microsoft Excel, Word, and costing models
• Ability to prepare and interpret budgets and work successfully in a team environment

Job Data by YubHub.

As a CTM, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Key responsibilities include:

• Evaluating the overall performance of site and site staff, and providing recommendations regarding site-specific actions
• Verifying the process of obtaining informed consent has been adequately performed and documented for each subject/patient
• Assessing factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
• Conducting Source Document Review of appropriate site source documents and medical records
• Verifying required clinical data entered in the case report form (CRF) is accurate and complete
• Applying query resolution techniques remotely and on site, and providing guidance to site staff as necessary
• Utilizing available hardware and software to support the effective conduct of the clinical project data review and capture
• May perform investigational product (IP) inventory, reconciliation, and reviews storage and security
• Routinely reviewing the Investigator Site File (ISF) for accuracy, timeliness, and completeness
• Documenting activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
• Supporting subject/patient recruitment, retention, and awareness strategies
• Entering data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills and ability to adapt to new technologies
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

Job Data by YubHub.

Core Responsibilities:

• General – Responsible for providing quality on deliverables at the country level and follows project requirements and applicable country rules, with 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 provides clear rationale for delays, assists with 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 (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/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 start-up advisor (CSA) and SAM. + Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision. + May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. + 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 – Supports the SAM to agree on country template contract and budget.

We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

Job Data by YubHub.