Senior, Site Budget and Contract Specialist (Romania)
The Senior Site Budget and Contract Specialist (Sr SBCS) leads the development of investigator budget and contract proposals. The Sr SBCS acts as the main point of contact for budget and contract negotiations for investigator sites across North America, EU and other countries, as applicable. The Sr SBCS will be responsible for all project activities related to contracts/budgets and will interact with clients, as needed. Frequent collaboration with internal teams is expected. Mentoring of more SBCS and other team members in the contracts/budgets related field.
This role will be perfect for you if:
You can easily achieve consensus while maintaining positive working relationships with external partners
Your team can count on you to get things done
You have an ease to work with numbers (standardized budgets)
RESPONSIBILITIES
Develop and maintain positive and productive relationships with clinical research sites and clients
Develop the draft clinical budgets for new studies
Develop and maintain the country-specific, sponsor approved, minimum and maximum budget grid for negotiation with sites (more complex studies)
Obtain the approved Clinical Trial Agreement (CTA) template to be used for the study from Legal Affairs
Develop the project-specific Clinical Trial Agreement (CTA) template for studies, customized per country-specific requirements on a global scale
Facilitate the negotiation and signature of the site budgets/contracts with investigators, in collaboration with Legal Affairs, and when appropriate with Sponsors. Adapt processes per country-specific requirements.
Manage contract/budget negotiations in countries outside of main region (EU-NA), if possible
Manage contract/budget amendments during the course of the trial
Update appropriate tracking systems to facilitate site payments
Regularly attend internal and client project team meetings, as necessary
Collaborate with internal teams as needed (i.e., Project Management, Regulatory Affairs, Legal Affairs, Finance, CTMS team, etc.)
Strategize to ensure deliverables for fully executed contracts are made on time, according to study timelines
Review and provide support to Regulatory Affairs on informed consent form (master template) to ensure subject compensation text is aligned with approved study budget
Depending on location and language of study sites, facilitate site negotiations and communications through the use of an intermediary party (i.e., sub-CRO or CRA)
Provide oversight to Sub-CROs on contracting activities, as required
Make all efforts to ensure total study budget is respected and within scope, across all sites. Escalates to sponsor for out-of-scope budget requests, as needed
For employees located outside of North America, provide assistance, as needed, to communicate with sites in local language, if possible
Maintain adequate training and compliance with internal processes and SOPs
Participate in internal departmental projects initiated by the site selection and contracting group
Participate in internal departmental projects initiated by other groups to provide insight on site budget and contracting activities as needed
Act as subject matter expert on budget and contract negotiations guiding project teams as needed
Support the Manager, Site Selection and Contracting to ensure knowledge of the goals, scope and requirements of the internal and external projects and to ensure high quality results are delivered
Mentor and assist in onboarding of new team members as well as provide trainings to the team on the specific processes related to contracts and budgets
Requirements
Education
Bachelor's degree in a field relevant to clinical research or equivalent experience.
Experience
Minimum of 5 years’ experience in site budget/contract negotiation in clinical research in the biotechnology, pharmaceutical, or CRO industry, including significant and relevant experience in study start-up activities and/or has worked closely with sites or worked in a site environment
Prior clinical research experience in EU and Asian countries, and knowledge of local regulations and processes is an asset
Experience of dermatological clinical research is an asset
Knowledge and skills
Excellent English written and spoken skills. Bilingual with French or other European language is an asset.
Strong ability to carry out different projects simultaneously, to organize their work effectively, and to work under pressure in accordance with deadlines.
Good judgment and problem-solving skills.
Excellent knowledge of the Microsoft Office suite (i.e., Word, Excel, PowerPoint, Outlook).
Experience in customer service is an asset
Strong interpersonal skills.
Our company
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
Permanent full-time position
Flexible schedule
Vacation
Home-based position
Ongoing learning and development
About Indero
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in Romania.
Description de poste
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Profil recherché
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Notre entreprise
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Apply To This Job
This role will be perfect for you if:
You can easily achieve consensus while maintaining positive working relationships with external partners
Your team can count on you to get things done
You have an ease to work with numbers (standardized budgets)
RESPONSIBILITIES
Develop and maintain positive and productive relationships with clinical research sites and clients
Develop the draft clinical budgets for new studies
Develop and maintain the country-specific, sponsor approved, minimum and maximum budget grid for negotiation with sites (more complex studies)
Obtain the approved Clinical Trial Agreement (CTA) template to be used for the study from Legal Affairs
Develop the project-specific Clinical Trial Agreement (CTA) template for studies, customized per country-specific requirements on a global scale
Facilitate the negotiation and signature of the site budgets/contracts with investigators, in collaboration with Legal Affairs, and when appropriate with Sponsors. Adapt processes per country-specific requirements.
Manage contract/budget negotiations in countries outside of main region (EU-NA), if possible
Manage contract/budget amendments during the course of the trial
Update appropriate tracking systems to facilitate site payments
Regularly attend internal and client project team meetings, as necessary
Collaborate with internal teams as needed (i.e., Project Management, Regulatory Affairs, Legal Affairs, Finance, CTMS team, etc.)
Strategize to ensure deliverables for fully executed contracts are made on time, according to study timelines
Review and provide support to Regulatory Affairs on informed consent form (master template) to ensure subject compensation text is aligned with approved study budget
Depending on location and language of study sites, facilitate site negotiations and communications through the use of an intermediary party (i.e., sub-CRO or CRA)
Provide oversight to Sub-CROs on contracting activities, as required
Make all efforts to ensure total study budget is respected and within scope, across all sites. Escalates to sponsor for out-of-scope budget requests, as needed
For employees located outside of North America, provide assistance, as needed, to communicate with sites in local language, if possible
Maintain adequate training and compliance with internal processes and SOPs
Participate in internal departmental projects initiated by the site selection and contracting group
Participate in internal departmental projects initiated by other groups to provide insight on site budget and contracting activities as needed
Act as subject matter expert on budget and contract negotiations guiding project teams as needed
Support the Manager, Site Selection and Contracting to ensure knowledge of the goals, scope and requirements of the internal and external projects and to ensure high quality results are delivered
Mentor and assist in onboarding of new team members as well as provide trainings to the team on the specific processes related to contracts and budgets
Requirements
Education
Bachelor's degree in a field relevant to clinical research or equivalent experience.
Experience
Minimum of 5 years’ experience in site budget/contract negotiation in clinical research in the biotechnology, pharmaceutical, or CRO industry, including significant and relevant experience in study start-up activities and/or has worked closely with sites or worked in a site environment
Prior clinical research experience in EU and Asian countries, and knowledge of local regulations and processes is an asset
Experience of dermatological clinical research is an asset
Knowledge and skills
Excellent English written and spoken skills. Bilingual with French or other European language is an asset.
Strong ability to carry out different projects simultaneously, to organize their work effectively, and to work under pressure in accordance with deadlines.
Good judgment and problem-solving skills.
Excellent knowledge of the Microsoft Office suite (i.e., Word, Excel, PowerPoint, Outlook).
Experience in customer service is an asset
Strong interpersonal skills.
Our company
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
Permanent full-time position
Flexible schedule
Vacation
Home-based position
Ongoing learning and development
About Indero
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in Romania.
Description de poste
null
Profil recherché
null
Notre entreprise
null
Apply To This Job