Clinical Contract Specialist

About the role:

The Clinical Contracts Specialist (CC Specialist) is responsible for the timely development of country budgets and Clinical Trial Agreement templates during the start-up stage of a Clinical Trial. The CC Specialist will work closely with Project Management, Regulatory & Start-Up, Clinical Operations, Finance, Legal teams, and the client to ensure finalization of approved site budgets and execution of approved site Clinical Trial Agreements.

The ideal candidate will be professional, analytical and possess excellent written and verbal communication skills.

Minimum Qualification & Experience

• Bachelor's Degree in a relevant field (science, law or other). 
• Minimum 3 years' experience in the clinical trials industry including experience in contract and budget negotiation in multiple countries. 
• Good knowledge of legal and medical terminology.  
• Understanding of business/financial concepts used in clinical trials.  
• Excellent communication and interpersonal skills. Good organizational skills; positive team player; attention to detail. 
• Proven ability to collaborate effectively with internal stakeholders (Clinical operations, legal, finance, procurement) and external stakeholders (Clients and Sites). 
• High level of attention to detail with the ability to manage multiple contracts and competing deadlines in a fast-paced environment. 
• Experience in managing 
• Business acumen  
• Proficiency in Microsoft Office (especially in Excel) 
• Ability to work collaboratively or individually in a fast-paced and deadline-driven environment.  

Responsibilities: 

Contracts 

• Understand which Clinical Trial Agreement template is used by countries in Novotech geographies; and where site specific templates are applicable. 
• Independent review and amendment of Clinical Trial Agreements within agreed negotiation parameters and policies.
• Escalate Clinical Trial Agreements outside of agreed negotiation parameters and policies as required; and obtain guidance and approval by Legal for any deviations.  
• Serve as key communication liaison between Sponsor and Novotech.  
• Manage assigned workload to deliver contract review at agreed service levels. 
• Work closely with local team, Project Management, Clinical Services, Finance and Legal teams to facilitate timely execution of site Clinical Trial Agreement.  
• Guides local team during the negotiation cycle to facilitate timely execution. 
• Support preparation and finalization of ancillary agreements as needed. 
• Facilitate the execution of contracts by company signatories. 
• Track executed contracts in appropriate system and collect relevant metrics. 
• Review and analyze any risk to Novotech and escalate to legal counsel, as necessary.  
• Serve as country point person for their country/region regarding Clinical Trial Agreements.  

Budgets 

• Review and QC of the investigator grant (country master budget) using industry standard systems. 
• Review the study protocol to ensure protocol assessments are included and consult with Clinical Services Team to confirm completeness of the budget. 
• Ensure industry standard of care concepts are incorporated into the budget and in line with Fair Market Value. 
• If required, obtain client review/approval of country budget. 
• Provide country budget to local team for negotiation with sites. 
• Independent review and amendment of site budgets within agreed negotiation parameters.  
• Escalate site budgets outside of agreed negotiation parameters as required and obtain guidance and approval by client for any deviations. 
• Work closely with local team, Project Management and Clinical Operations to facilitate timely finalization of site budgets. 
• Guides local team during the negotiation cycle to facilitate timely approval. 
• Track finalised budgets in appropriate system and collect relevant metrics. 
• Serve as country contact point person for their country/region regarding investigator grants. 
• Any other tasks as assigned by Line Manager. 

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

• Understand which Clinical Trial Agreement template is used by countries in Novotech geographies; and where site specific templates are applicable.
• Independent review and amendment of Clinical Trial Agreements within agreed negotiation parameters and policies.
• Escalate Clinical Trial Agreements outside of agreed negotiation parameters and policies as required; and obtain guidance and approval by Legal for any deviations.
• Serve as key communication liaison between Sponsor and Novotech.
• Manage assigned workload to deliver contract review at agreed service levels.
• Work closely with Project Management, Clinical Services, Finance and Legal teams to facilitate timely execution of site Clinical Trial Agreement.
• Support preparation and finalisation of ancillary agreements as needed.
• Facilitate the execution of contracts by company signatories.
• Track executed contracts in appropriate system and collect relevant metrics.
• Review and analyse any risk to Novotech and escalate to legal counsel, as necessary.
• Serve as country point person for their country/region regarding Clinical Trial Agreements.

• Develop the investigator grant (country master budget) using industry standard systems.
• Review the study protocol to ensure protocol assessments are included and consult with Clinical Services Team to confirm completeness of the budget.
• Ensure industry standard of care concepts are incorporated into the budget and in line with Fair Market Value.
• If required, obtain client review/approval of country budget.
• Provide country budget to local team for negotiation with sites.
• Independent review and amendment of site budgets within agreed negotiation parameters.
• Escalate site budgets outside of agreed negotiation parameters as required and obtain guidance and approval by client for any deviations.
• Work closely with Project Management and Clinical Operations to facilitate timely finalisation of site budgets.
• Track finalised budgets in appropriate system and collect relevant metrics.
• Serve as country contact point person for their country/region regarding investigator grants.
• Any other tasks as assigned by Line Manager.

• Bachelor's Degree in a relevant field (science, law or other).
• Minimum 3 years' experience in the clinical trials industry including experience in contract and budget negotiation.
• Good knowledge of legal and medical terminology.
• Understanding of business/financial concepts used in clinical trials.
• Excellent communication and interpersonal skills. Good organisational skills; positive team player; attention to detail.