Global Clinical Site Contracting Lead

3 tygodni temu

Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etat
Site Name: UK – London – New Oxford Street, Warsaw
Posted Date: Mar 17 2025

The Global Clinical Site Contracting Lead plays a crucial role within the Global Site Budgets & Contracts (GSBC) group. This position is responsible for supporting the site contracting processes to ensure timely site initiation and compliance with relevant legal and regulatory requirements. The role involves collaboration with various stakeholders to streamline processes, manage contract data, and provide training and support to end-users.

This role will be part of the GSBC group who function as a global Centre of Excellence for the entire end-to-end site contracting process (e.g., from protocol development to study conclusion), providing an integrated, consistent approach where applicable to clinical site contracting across Rx and Vx. Further the GSBC group would be accountable for:

  • Functioning as a global connection and business expert to countries for consistency and issue escalation and resolution for site related contracts
  • Serving as central POC to share best practices and local efficiencies across countries, as well as providing central, consistent direction
  • Streamlining site contracting related processes and ways of working that minimizes the need for consultation with GSK Legal
  • Database accountability for GSK and GSK-CRO hybrid approved clinical site related agreement templates (e.g., Confidentiality Disclosure Agreement, Clinical Study Agreement)
  • Establishing and maintaining contract related training materials, guidance documents and GSK contract playbooks
  • Evaluating and implementing global tech-enabled solutions to increase efficiency and reduce errors (e.g., Contract Lifecycle Management systems/tools)

Key Responsibilities

  • Generate country and global reports, data and analytics within site contracting systems/tools to provide insights into contract performance and risk exposure.
  • Support the Associate Director or, Global Director to identify and gather site contracting data to provide strategic solutions and mitigate risks.
  • Collaborate cross-functionally with Legal, Tech, Purchasing, Finance, Clinical Operations, and Vendors to improve contract processes and templates.
  • As and when requested maintain the Global or, GSK-CRO hybrid approved clinical contract templates (e.g., Confidentiality Disclosure Agreement, Clinical Study Agreement).
  • Provide guidance within the confines of the applicable GSK playbooks/standard operating procedures, work instructions or, policies and triaging of site contracting escalations and issues to the appropriate internal/external stakeholders to ensure these are resolved promptly and do not delay site contracting delivery.
  • Serve as a key point of contact for sharing site contracting best practices and efficiencies across countries and stakeholders.
  • Develop and implement training guides, work instructions, SOPs and governance frameworks related to clinical site contracting
  • Provide training and assistance to end-users, on utilising site contracting related technology solutions.
  • With oversight, may co-lead or, participate in providing educational training to internal GMASE/GCD stakeholders or, other functions within GCO or, external CRO partners on changes to global contractual terms and obligations to ensure compliance and understanding
  • As requested by Associate Director or, Global Director support the evaluation of global tech-enabled solutions (including any upgrades) to increase efficiency and reduce errors across site contract management and ensure overall performance, compliance, and quality in site contracting.

Qualifications & Skills

  • Bachelor's degree in business, science, healthcare, or a related discipline
  • Several years of relevant experience in the Pharmaceutical, Biotech, or Healthcare Industry with an emphasis on clinical contracting practices or, legal related discipline

Preferred Qualifications

  • Experience in implementing contract management processes/systems

Job-Related Experience/Skills/Background

  • Operational knowledge of clinical research with experience in all stages of study lifecycle (e.g., start-up, recruitment and close-out) and understanding of R&D and drug/vaccine development process
  • Demonstrated ability to influence cross-functionally with ability to coordinate project/timelines, with ability to use interpersonal styles and communication methods to gain acceptance of an idea
  • Extensive knowledge of contract lifecycle management and understanding of legal terms related to clinical trials
  • Strong business acumen, planning, negotiation, and organisational skills
  • Experience in developing and implementing SOPs, work instructions, training guides and governance frameworks related to clinical trial contracting
  • Demonstration of effective team and values contributions of others within the team
  • Anticipation of problems and proactively seeking input from other team members or stakeholders to mitigate or solve them
  • Understanding of the implications of decisions made by project/study team and proactive identification of risks where appropriate; taking necessary actions and seeking to mitigate risks where appropriate

Closing Date for Applications – 20 March 2025 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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