Clinical Trials (Senior) Site Contracts Manager

  • 1 Occam Court, Guildford, United Kingdom
  • Employees can work remotely
  • Full-time

Company Description

Ergomed is a rapidly growing  global clinical research company.  We perform clinical trials  for rare and complex diseases.

Ergomed Plc is a public company on the London stock exchange.

The company boasted 40% growth in its revenues in its last report.  This success is due to the hard work of our highly skilled employees and our subsequent  reputation for excellence with our clients. 

Job Description

  • 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.

  • 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 delivery 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 Ergomed’s 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 oversee people management activities including interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counselling.

  • Facilitates processes, resourcing, and communications within a department, across departments, or within the country assigned.  Acts as liaison and facilitator between customer leaders and senior management for related tasks and/or issues.  Serves as a departmental point of escalation for internal and external customers.

  • Responsible & accountable for the effective operations on Site Contracts deliverables across all regions, within the assigned programs/projects.

  • May develop and maintain strategic relationships with customers. Collaborates with business leads for business development, project management, clinical management, operational personnel, and executive management to achieve project and departmental goals.  Ensures that individual project targets are met, clients are satisfied, services are provided with the highest quality standards and policies and procedures are followed.

  • Supports reporting of department and team metrics/cycle times and strategies to improve metrics/cycle times.

  • Guarantees Site Contracts delivery of assigned projects and/or initiatives.

  • Develops and implements training programs for Site Contract teams.  

  • Develops requirements for modifications to existing systems, metrics and reports based on input from functional teams.  

  • Leads larger teams of local subject matter experts in the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes.

  • Responsible for creating a predictable project experience for both employees and clients alike.

  • Contributes to and may lead change initiatives across the SSU department.

  • Develops and implements strategies and tools for tracking metrics/cycle times.  

  • Ability to represents Ergomed at professional meetings or seminars.  

  • Establishes and maintains training materials for assigned areas.

  • Performs other work-related duties as assigned.  

Qualifications

  • BS degree in life sciences, a health-related field, or equivalent combination of education and experience. 

  • Strong CRO operational experience with a track record in Site Contracts Management working in an international or global capacity.

  • Thorough knowledge of applicable regulations, drug development and clinical project management procedures. 

  • Understanding of the specific country requirements pertaining to Site Contracts delivery in at least Europe (other regions are a plus) and the ability to work across geographic regions.  

  • Ability to mentor and coach lesser experienced staff and supports SSU Management on all administrative or departmental activities.

  • Good presentation, documentation and interpersonal skills. Proficient in MS Office (Word, Excel and PowerPoint), outlook and Internet. 

  • Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.

  • Attention to 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 lesser experienced team members.  

 

Privacy Policy