Ref #: 37584

Employment type: Permanent - Full-Time

Location: United Kingdom

Posted: 11-May-2022

Description

As a Site Contract Specialist you will bring experience working within UK clinical trial setting and understand clinical trial agreements, UK site contract negotiation and join our client’s Contract & Compliance Services (CCS).

As Site Contract Specialist , you will prepare, negotiate and finalize agreements and budgets related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of site/investigator budgets and contracts.

The role will involve:
• Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Escalate as appropriate.
• Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and the pricing guidelines. Participate in and/or lead approval escalations as appropriate.
• Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
• Participate in discussions related to the development of site/investigator budgets aligned with fair market value.
• Manage the contract amendment lifecycle.
• Work with the global CCS team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions. Escalate issues as appropriate.
• Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
• Assume responsibility for all aspects of legal document and metrics tracking.
• Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
• CCS management and functional CCS support teams such as, legal, Healthcare Compliance (HCC), Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.
• Track all aspects of legal document and metrics. Determine potential needs for contract amendments and manage amendment lifecycle.
• Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
• Adhere to SOPs, ethics and departmental compliance as determined by management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS, and operating companies. Comply with requests from QA and auditors.
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. SATS) according to expectations (metrics) and archiving retention requirements.
• Ensure inspection ready and comply with relevant training requirements and developing therapeutic knowledge to ensure service delivery.

Education and Experience Requirements:
• Bachelor’s degree in appropriate scientific or business disciplines
• 3 years’ experience and/or equivalent competencies in legal/ pharmaceutical industry/clinical research.
• Excellent communication skills (both oral and written).
• Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.).
• Familiarity with clinical research processes.
• Ability to work effectively in cross function teams.
• Able to work independently as well as in a collaborative team environment.
• Strong and proven negotiation and problem resolution skills.
• Working knowledge of PCs (MS Office suite at a minimum) and database management.
• Fluency in English.
• Must demonstrate innovative spirit, have strong interpersonal skills, ability to manage a high volume of work.

Please note you MUST have experience working within clinical research from Pharma or CRO and you MUST have the right to work in UK without the need of sponsorship.

What is offered
• Permanent and full-time contract of employment seconded 100% to the one sponsor
• Homeworking with expectations to attend the client office for meetings
• Salary depending on level of skills and experience plus company benefits (25 days annual leave, pension, healthcare cover, etc.)

To express your interest please contact me at:
Tanzina.Guerni@docsglobal.com

Benefits of working with ICON

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.