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:
- Oversees negotiations of clinical study agreements (CTA´s) on a study level and drives 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.
- Provides oversight of contact & budget negotiations status and manages escalation of out-of-parameter queries on budgetary and contractual requests to sponsor decision-makers in all regions of study conduct.
- Acts as first-line subject matter expert for all such CTA elements on assigned studies for internal and sponsor stakeholders alike.
- Plans contract execution strategy for assigned studies,including forecast of site-specific contractual execution timelines with as much accuracy as possible,and coordinates with internal study team stakeholders to ensure that CTA strategy is aligned with overall study start-up plans and expectations overall.
- Works closely with internal stakeholders and with Sponsor to prepare site contractual templates, including payment terms, and study-level negotiation parameters and processes within Company standards in order to drive successful negotiation of contracts and budgets.
- Establishes strong working relationships and collaboration with Sponsor to ensure site contractual templates fit into the global strategy set for the program.
- Creates and maintains document status reports, and updates department tools/systems and team members on a regular basis; ensures appropriate documentation is maintained.
- Collaborates with internal and external legal, finance and clinical operations departments, including communicating and explaining legal and budgetary issues.
- Manages site and study level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment terms within corporate and industry standards during negotiation with sites.
- May support BU and organization through help desk and other defined pathways to resolve and deescalate issues.
- Performs other work-related duties as assigned.
The ideal candidate will have:
- 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 (Study Coordinator, CRA, Pharmacy, Nursing, Healthcare Administration) or site start-up experience.
- 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.
- Strong leadership skills; ability to teach/mentor team members