Job Description

The Clinical Contracts Specialist (CC Specialist)/ Senior Clinical Contracts Specialist (SCC Specialist) are responsible for oversight and the timely development and approval of master/country/site level budgets and execution of Clinical Trial Agreement templates during the start-up stage of a Clinical Trial on a regional level (multiple countries). The CC Specialist/ SCC Specialist will work closely with Project Management, Regulatory & Start-Up, Clinical Operations, Finance, Legal teams, and the client to ensure finalisation 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.

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 and or Finance 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.
• Acts as primary guide to Local Study team for site level budget and Clinical Trial Agreement negotiation, ensuring system tracking, legal and budget status is provided timely.
• Guides local team during the negotiation cycle to facilitate timely execution.
• 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 or finance team, as necessary.

• Serve as country point person for their country/region regarding Clinical Trial Agreements.

  Budgets

• Review and QC of the investigator grant (Master and Country budgets) 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.
• Liaise with clients for their review/approval of Country budgets and sets internal budget parameters (low and high FMV benchmarks) with Sponsors.
• Create Site level budgets from the Country budgets and to provide both Country and Site level budgets to local study team for to use as an internal parameter and to start 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 study team, Project Management and Clinical Operations to facilitate timely finalisation 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.

  Other responsibilities:

• Attend to weekly Sponsor calls and present contracts and budget status (highlighting achievements, delays, identified risks and mitigation).
• Managing multiple priorities and projects simultaneously while fostering positive relationships with both internal teams and external partners to support efficient trial start-up and overall clinical development timelines.

• Any other tasks as assigned by Line Manager.

  Senior Clinical Contracts Specialist In addition to the above, responsibilities are to:

• Contribute to development and maintenance of contract and budget processes and tools.
• Identify areas of inefficiency in process and make recommendations for improvements.
• Assist with the development and delivery of training in the contracts and budgets area in conjunction with the Learning and Development department; and serve as a mentor to junior CC Specialists. Provides strategic leadership and works collaboratively with sponsors to develop mitigation approaches for complex and high-risk studies.

Qualification: Clinical Contracts Specialists (CCS)

• 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 (at least 2 countries).
• 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
• Proven ability to collaborate effectively with internal stakeholders (Clinical operations, Regulatory Start-Up, Project Management, Legal, Finance, ) 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 successfully managing and overseeing high volume of sites (approximately 50 sites depending on the region) and projects simultaneously.
• Business acumen
• Proficiency in Microsoft Office (especially in Excel and Outlook)
• Ability to work collaboratively or individually in a fast-paced and deadline-driven environment.

Senior Clinical Contracts Specialist (SCC Specialist) In addition to the CCS Qualifications & Experience above:

• · A SCC Specialist will have a minimum of 4-5 years’ experience in site budget and contract preparation and finalisation over 3 or more countries.
• Lead experience in overseeing multiple complex projects and providing oversight to junior colleagues
• Be able to demonstrate strong planning and problem-solving abilities, with a proven track record of applying these skills in fast-paced or complex environments
• Contributed to internal process improvement for efficiency in study timelines.

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.

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 and or Finance 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.
• Acts as primary guide to Local Study team for site level budget and Clinical Trial Agreement negotiation, ensuring system tracking, legal and budget status is provided timely.
• Guides local team during the negotiation cycle to facilitate timely execution.
• 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 or finance team, as necessary.

• Serve as country point person for their country/region regarding Clinical Trial Agreements.

  Budgets

• Review and QC of the investigator grant (Master and Country budgets) 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.
• Liaise with clients for their review/approval of Country budgets and sets internal budget parameters (low and high FMV benchmarks) with Sponsors.
• Create Site level budgets from the Country budgets and to provide both Country and Site level budgets to local study team for to use as an internal parameter and to start 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 study team, Project Management and Clinical Operations to facilitate timely finalisation 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.

  Other responsibilities:

• Attend to weekly Sponsor calls and present contracts and budget status (highlighting achievements, delays, identified risks and mitigation).
• Managing multiple priorities and projects simultaneously while fostering positive relationships with both internal teams and external partners to support efficient trial start-up and overall clinical development timelines.

• Any other tasks as assigned by Line Manager.

  Senior Clinical Contracts Specialist In addition to the above, responsibilities are to:

• Contribute to development and maintenance of contract and budget processes and tools.
• Identify areas of inefficiency in process and make recommendations for improvements.
• Assist with the development and delivery of training in the contracts and budgets area in conjunction with the Learning and Development department; and serve as a mentor to junior CC Specialists. Provides strategic leadership and works collaboratively with sponsors to develop mitigation approaches for complex and high-risk studies.

Clinical Contracts Specialists (CCS)

• 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 (at least 2 countries).
• 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
• Proven ability to collaborate effectively with internal stakeholders (Clinical operations, Regulatory Start-Up, Project Management, Legal, Finance, ) 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 successfully managing and overseeing high volume of sites (approximately 50 sites depending on the region) and projects simultaneously.
• Business acumen
• Proficiency in Microsoft Office (especially in Excel and Outlook)
• Ability to work collaboratively or individually in a fast-paced and deadline-driven environment.

Senior Clinical Contracts Specialist (SCC Specialist) In addition to the CCS Qualifications & Experience above:

• · A SCC Specialist will have a minimum of 4-5 years’ experience in site budget and contract preparation and finalisation over 3 or more countries.
• Lead experience in overseeing multiple complex projects and providing oversight to junior colleagues
• Be able to demonstrate strong planning and problem-solving abilities, with a proven track record of applying these skills in fast-paced or complex environments
• Contributed to internal process improvement for efficiency in study timelines.