Global Site Contracts Lead

3 days ago

Pretoria, Gauteng, South Africa Parexel Full time

Parexel's Vision for Excellence


Parexel is dedicated to improving the world's health by providing biopharmaceutical services that transform scientific discoveries into new treatments. Our team of experts is passionate about delivering high-quality services that meet the needs of our clients across the globe.


Job Summary


We are seeking a highly skilled and experienced Global Site Contract Lead to join our team in Hungary, Poland, Romania, Spain, South Africa, Israel, Italy, and the UK. As a key member of our Clinical Operations team, you will be responsible for negotiating study-specific Clinical Site Agreements (CSAs) with sponsors and supporting the Project Lead in the negotiation of country budgets.


Key Responsibilities



  • Negotiate study-specific CSA templates with sponsors and support the Project Lead in the negotiation of country budgets.
  • Manage CSA activities and liaise with the Project Lead, GRO Lead, and sponsors to ensure CSA start-up deliverables are met.
  • Coordinate the local Clinical Trial Specialist/Clinical Research Associate working on CSAs on a project level.
  • Act as a functional specialist on projects and develop study-specific CSA strategies.
  • Agree and negotiate study-specific generic and country CSA templates with sponsors.
  • Support the Project Lead in the negotiation of country budgets with sponsors.
  • Gather relevant study information from the Project Lead.
  • Discuss and finalize specific country CSA templates with input from sponsors, Project Leads, and GRO Leads as appropriate.
  • Store the final approved and complete country template and country budget PMED upon sponsor approval.
  • Communicate CSA strategy, CSA turnaround timelines, CTMS tracking requirements, and budget information/updates with assigned CTS/CRAs.
  • Provide agreed study and country CSA templates to local CTS/CRAs for country-specific adaptation.
  • Coordinate interaction between GRO Leads, Project Leads, and sponsors, including overall timeline management for CSAs.
  • Coordinate overall CSA process with assigned CTS/CRAs and status reporting to GRO-Leads/Project Leads.
  • Provide updates about template amendments, process changes, investigator fees, local requirements, etc., to ensure relevant CSA databases are up-to-date.
  • Maintain comprehensive language trackers.
  • Recognize areas of potential problems early and formulate contingency plans.
  • Define solutions strategies for significant CSA changes requested by sites, while minor administrative changes are done by local CTS/CRAs.
  • Evaluate and identify resourcing needs of SSU staff to be assigned on the project and provide performance feedback as appropriate.
  • Participate in client, investigator, and team meetings.
  • Identify and facilitate CSA training needs of local CTS/CRAs.
  • Maintain and assure quality of work generated.
  • Compile CSA status within a project as agreed with Project Leads and GRO Leads.
  • Prioritize effectively and respond to urgent requests within teams or sponsor leads.
  • Provide mentoring and coaching to CTS staff.
  • Resolve negotiation issues that have arisen at clinical sites and escalated from CTS that cannot be resolved by CTS after several attempts.
  • Escalate changes that fall outside documented 'fall-back' parameters, if available, to the Sponsor or to Clinical Site Agreement Manager as appropriate.
  • Provide internal and Sponsor approval to CTS for signature of the fully agreed CSA according to applicable PAREXEL or Client instructions.
  • Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, and PAREXEL WSOPs and study-specific procedures.
  • Complete routine administrative tasks in a timely manner (e.g., Timesheets, metrics, travel expense claims).

Requirements



  • Experienced CRA, CTS, or senior person with a legal or business degree or other relevant experience, preferably in one of the following environments: Contracting, Clinical Operations, Legal (Paralegal), or in a comparable function in another CRO or pharmaceutical company.
  • Global Site Contract Lead experience.
  • Excellent computer and internet skills, including excellent knowledge of MS-Office products such as Excel, Word.
  • Possess strong negotiation, diplomacy, team leadership skills, and excellent organizational ability.
  • Excellent interpersonal, verbal, and written communication skills.
  • Ability to motivate both individuals and a team.
  • Ability to successfully work in a 'virtual' team environment.
  • Ability to complete tasks in an accurate, timely manner and effectively manage multiple tasks.
  • Shows commitment to and performs consistently high-quality work.
  • Ability to identify and address issues proactively in a timely manner.
  • Ability to take initiative, work independently, and delegate.

Education



  • Degree in business, legal, or life science or other relevant work experience in Contracting, Clinical Operations, or in Legal (Paralegal).

Language Skills



  • Fluent in written and spoken English and local language.

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