Description
Syneos Health is seeking a Site Contracts Lead to manage negotiation of clinical study agreements (CTAs) on a study level and drive CTA document finalization and execution.
The successful candidate will oversee negotiations of clinical study agreements (CTAs) on a study level and drive CTA document finalization and execution, including contractual language & terms, financial attachments, and investigator grant budgets in collaboration with a global team of site contract & budget negotiators.
Key responsibilities include:
- Providing oversight of contact & budget negotiations status and managing escalation of out-of-parameter queries on budgetary and contractual requests to sponsor decision-makers
- Acting as first-line subject matter expert for all CTA elements on assigned studies for internal and sponsor stakeholders alike
- Planning contract execution strategy for assigned studies and coordinating with internal study team stakeholders
- Coordinating communications between study team stakeholders and global team of site-facing site contract & budget negotiators
- Working closely with internal stakeholders and with Sponsor to prepare site contractual templates
- Establishing strong working relationships and collaboration with Sponsor to ensure site contractual templates fit into the global strategy set for the program
- Creating and maintaining document status reports and updating department tools/systems and team members on a regular basis
- Collaborating with internal and external legal, finance and clinical operations departments
- Managing site and study level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment terms
- May support BU and organization through help desk and other defined pathways to resolve and deescalate issues
- Performs other work-related duties as assigned
Requirements:
- BS degree in life sciences, a health related field, or equivalent combination of education and experience
- Preferred experience in a CRO/pharmaceutical industry and related clinical trial expertise
- Thorough knowledge of applicable regulations, drug development and clinical project management procedures
- Good presentation, documentation and interpersonal skills
- Proficient in MS Office (Word, Excel and PowerPoint), MS Project, outlook and Internet
- Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment
- Attention to detail, effective oral/written communication skills along with the ability to work independently to meet deadlines