The Site Budget and Contract Specialist is a key member of the Site Selection and Contracting team. This person works closely with project teams as well as the legal / contract department in the preparation, negotiation and execution of budgets and contracts (clinical trial agreement – CTA) with investigator sites across EU, North America and other countries.
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
Contracts and budgets preparation
- Obtains the minimum and maximum site budget prepared by Business Development and approved by the Sponsor.
- Obtains the project-specific site CTA template from Legal Affairs and Contracts approved by the Sponsor.
- Prepares the contract schedule (study information, timelines and payment information) in collaboration with the Project Manager.
- Prepares and sends the Sponsor-approved contract and budget to sites for review.
Contracts and budgets negotiations
- Manages budget negotiation with the sites to ensure budget remains within the Sponsor-approved limits and escalate issues as necessary
- Manages contract negotiation with sites and escalates legal language requests to Legal Affairs and Contracts and to the Sponsor, as necessary
- Keeps track of progress with contract/budget negotiation and timelines for site activation using CTMS or other tracking system
- Keeps project team informed of progress and of any potential delays
- Finalizes the site contract/budget and obtains the necessary signatures
- Informs the appropriate parties of contract execution in a timely manner
- Updates CTMS, all necessary trackers, and ensures proper filing of the contract/budget and communications
Follow up and close out
- Manages the site contract / budget amendments process during the course of the trial
- Performs site budget reconciliation during the negotiation process and at study closure
- May coordinate, with Legal Affairs and Contracts, the review and negotiation of the confidentiality disclosure agreement of the interested sites
- Maintains and develops a productive and professional relationship with research sites, Sponsor and project teams
- Participates in meetings with Project Managers and / or Sponsor as required
IDEAL PROFILE
Education
- Bachelor's degree in a field relevant to clinical research or equivalent experience.
Experience
- Minimum of 3 years of clinical research experience in the biotechnology, pharmaceutical or CRO industry, including 2 years of experience managing site budget negotiation
- Good knowledge of good clinical practice, ICH standards and applicable regulations
Knowledge and skills
- Excellent English written and spoken skills.
- 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.
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.
Skills Required
- Bachelor's degree in a field relevant to clinical research
- Minimum of 3 years of clinical research experience in biotechnology, pharmaceutical or CRO industry
- 2 years of experience managing site budget negotiation
- Good knowledge of good clinical practice, ICH standards and applicable regulations
- Excellent English written and spoken skills
- Excellent knowledge of the Microsoft Office suite
What We Do
As a CRO (Contract Research Organization) specialized in dermatology and rheumatology, we provide scientific guidance, accurate results and customer satisfaction. Our unique service offering combines specialized Contract Research Services, knowledge of dermatology sites in North America and Europe reach and the extended capabilities of a large clinical research site. The design and conduct of Phase I to Phase IV studies is our core expertise. Our specialized services include: • Study Design and Protocol Development • Submission to Regulatory Agencies and Central Ethics Committees • Regulatory Consulting • Trial Master Files Management • Project Management • Investigator / Site Selection • Patient Recruitment • Clinical Monitoring • Medical Monitoring • Pharmacovigilance • Data Management • Biostatistical Analysis • Clinical Study Report • Medical Writing / Publication Since 2000, Innovaderm has built a strong reputation for the quality of its research and the care offered to its study participants, its clients and its sites, often exceeding our client’s timeline expectations.
