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Site Contracts Lead - Beijing/Shanghai/Homebased

Employer
Syneos Health - Australia
Location
Shanghai, CHN
Salary
Competitive
Start date
13 May 2022
Closing date
10 Jun 2022

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Job Description

JOB TITLE: Sr Site Contracts Lead

BUSINESS UNIT

(COMMERCIAL ONLY):

REPORTS TO: Associate Director, Site Start-Up & Regulatory; or designee

JOB SUMMARY Manages negotiation 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 negotiators for Site Contracts Service Center for awarded projects. Ensures global CTA negotiation comply with sponsor and Company requirements. Identifies project and/or Company level investigator budget related problems, and works with internal and external team members to provide and implement solutions. Establishes strong working relationships with customers and internal project teams. Supports global operational initiatives at the project, Sponsor or relationship level. May serve as strategic point of contact for internal and external customers to meet site contracting/budgeting goals.

JOB RESPONSIBILITIES

  • 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 issues, and escalation point within the Company for internal customers to seek assistance.
  • 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. Provides consultation during escalation of out-of-parameter queries as needed.
  • Advises study team and Sponsor stakeholders on industry trends, norms, and emergent developments surrounding site contract and budgetary negotiations. Provides consultation on potential risks and mitigation tactics for negotiation issues pertaining to overall study start-up needs.
  • Acts as first-line subject matter expert for all such CTA elements on assigned studies for internal and sponsor stakeholders alike. Advises stakeholders on issue resolution within the context of assigned studies. May seek additional support from internal support structures as needed.


  • 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. Manages expectations of internal and sponsor study team regarding global CTA negotiations for assigned studies.
  • Coordinates communications between study team stakeholders and global team of site-facing site contract & budget negotiators including roll-up of all status updates to regular team forum. Participates in regular study calls to facilitate communication as needed.
  • 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.
  • Identifies possible site contractual and investigator budgetary document or process operational risk and proactively works to provide solutions. Establishes strong working relationships with customer and internal project teams. Escalates deviations to senior management and is equipped to resolve issues with Quality Assurance.
  • 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.
  • Identifies best practices, investigates root causes of fundamental issues and problems for projects and recommends solutions.
  • Trains and mentors less experienced staff members on department Standard Operating Procedures (SOPs), processes, tools and templates and ensures quality of teamwork products.
  • Represents the Company at professional meetings or seminars.
  • May support BU and organization through help desk and other defined pathways to resolve and deescalate issues.
  • May identify and lead internal team training and/or process improvement initiatives.
  • Participates in business development presentations as a subject matter expert in site contracts and investigator budget management within the Company
  • Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).


QUALIFICATION REQUIREMENTS

  • BS degree in life sciences, a health related field, or equivalent combination of education and experience.
  • Extensive 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.
  • Excellent 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.
  • Above-average attention to detail, effective oral/written communication skills along with the ability to work independently to meet deadlines.
  • Excellent leadership skills; ability to teach/mentor team members. Ability to coach employees to reach performance objectives.
  • Strong background in issue resolution, meeting customer deliverables and driving best practices at organization or customer portfolio level.

Company

Join a game-changing company that is reinventing the way therapies are developed and commercialized!

Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform.

A career with Syneos Health means your everyday work improves patients’ lives around the world.

Company info
Website
Telephone
+61 2 8437 9200
Location
Suite 1, Level 2
924 Pacific Highway
Gordon
NSW 2072
AU

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