Performs site qualification, site initiation, interim monitoring, site management and close out visits (performed on site or remotely) ensuring regulatory, ICH GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site specifi

Oversees and ensures the completion of tasks required to support end users with the selection, onboarding, oversight and offboarding of Vendors/Vendor services used in support of clinical trial delivery Contributes details of Vendor capabilities and/or expertise in support of proposals and other Business Development initiatives. Supports customers with Vendor sourcing str

Maintains ownership of and manages contract process to ensure timely delivery and execution consistent with standard cycle times, including but not limited to, the coordination and finalization of the contractual instrument and budget to align with defined scope of work. Negotiates and prepares contracts, budgets and related documents for participation in complex clinical

Participates in regular reviews of assumptions and algorithms and identifies and implements required changes by collaborating with Proposals, Contracts, Change Orders, and Functional Group leaders. Collaborates with internal and external customers to understand their pricing related needs, and implements customized solutions. In the majority of cases, this involves workin

Act as central point of contact for all modules for end users for resolution of operational, process and advanced questions about system navigation and functionality (example data setup, site management, site monitoring, templates, filing, reporting, etc.). Provide business process and system expertise to support clinical project teams and functional teams regarding prope

Performs site qualification, site initiation, interim monitoring, site management and close out visits (performed on site or remotely) ensuring regulatory, ICH GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site specif

Development of protocols for clinical studies. Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans Drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Clinical Study Reports, Annual Reports and other Health Authority

Develop, validate and optimize bioanalytical methods by using analytical techniques. Process, analyze and interpret bioanalytical data. Responsible for finding solutions to problems related to the application of bioanalytical methods. Assist in improving laboratory activity processes (method development, validation and sample analysis). Write and review bioanalytical meth

The Technology & Data Solutions (TDS) business unit is the Syneos Health accelerator for life sciences innovation. TDS houses our advanced technology acquisitions, homegrown products & applications, actively participates in new M&A and partnership activities, delivers critical insights as part of our integrated strategy for customers and drives enterprise wide adoption an

Project Leadership and Delivery Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements. Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout accordin

Establishes, maintains and updates training material for site contracts lead team and site contract negotiators. Actively participates in higher level discussions about overall company goals, functional objectives in the Business Unit (BU), and specific project aims. Serves as subject matter expert within the organization equipped to help resolve global site contracting i

Responsible for site management oversight, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. May be responsible for identific

Project Leadership and Delivery Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements. Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout accordin

The Technology & Data Solutions (TDS) business unit is the Syneos Health accelerator for life sciences innovation. TDS houses our advanced technology acquisitions, homegrown products & applications, actively participates in new M&A and partnership activities, delivers critical insights as part of our integrated strategy for customers and drives enterprise wide adoption an

Data Product Manager will lead development of data products that will power predictive models, data offerings, APIs, and software solutions at a global Contract Research Organization. JOB RESPONSIBILITIES Product Leadership. Lead the end to end development of a portfolio of data products, from ideation to deployment to maintenance and continuous improvement through acquis