Contracts Manager (CM) - home-based position in Spain.
Caidya is seeking a Contracts Manager (CM) to join our team.
As a Contracts Manager, you will play a critical role in overseeing the cross-functional execution of Clinical Contracts, ensuring consistency and quality throughout the process. Your responsibilities will include supporting the study Project Manager, collaborating with the Clinical Trial Regulatory Manager, Study Startup Lead, and other key personnel to deliver timely negotiation and execution of site contracts and budgets. Your expertise will ensure accurate forecasts of contract execution timelines and support cross-functional coordination for site activations. This position requires prior experience in site contract negotiations, a strong understanding of budget fair market value practices, applicable legal regulations, including GDPR, and the administrative requirements of participating study sites and countries.
Key duties include acting as the Clinical Contracts Lead for assigned countries, managing Contracts Specialists, creating study-specific contract templates, and directly negotiating contracts and budgets when necessary. You will be responsible for maintaining and updating country-specific contract templates, conducting fair market value assessments, and serving as an internal point of escalation to resolve legal language negotiations. The ideal candidate will have a BA/BS degree in a related field, with advanced degrees or legal education preferred, and a minimum of three years of contracts-related experience, preferably in a CRO or pharma setting. Proficiency in MS Word, Excel, PowerPoint, and industry benchmarking tools is advantageous. Exceptional organizational skills, attention to detail, and excellent English communication skills are essential for success in this role. If you are a proactive problem-solver with a keen understanding of contracting principles and clinical trial processes, we invite you to apply with an English Language CV and join our dynamic team.
Job Description:
Job Title: Contracts Manager
Job Location: Madrid, Spain (Home-based position, any location in mainland Spain considered)
Job Overview:
The Contracts Manager (CM) will oversee the cross-functional execution of Clinical Contracts to ensure consistency and quality while identifying and solving any issues that potentially would delay the negotiation and execution of site contracts. The Lead directly supports the study Project Manager by collaboration with Clinical Trial Regulatory Manager (CTRM), Study Startup Lead (SSUL), and assigned personnel from the start-up functional areas: Site Contracts, Site Budgets, Feasibility, and Country Specialists. The CM provides Clinical Contracts strategy, and expertise to deliver timely negotiation of site contracts and budgets and to ensure accurate forecasts of contract execution timelines to support cross-functional coordination and delivery of site activations. The strategy will reflect the lead’s prior site contract and budget experience and technical knowledge of contract negotiations, budget fair market value practices, applicable legal theories and regulations, including GDPR, and administrative requirements of participating study sites and countries.
Job Duties and Responsibilities:
- Act as the Clinical Contracts Lead for the assigned countries and regions participating directly at kick-off meetings, sponsor calls providing the client with procedural and legal guidance, and study updates and advice as how to expedite and facilitate site contract execution.
- Prepare the forecast of all Clinical Contract intermediate steps and oversees the execution in order to achieve contractual milestones.
- Manage the Contracts Specialists appointed to the project and ensure they are included and granted access to all applicable study-specific systems including appropriate Egnyte folder, D365, eTMF, and study startup system accesses.
- Accountable for creation of all study-specific contract templates within assigned countries of oversight, through either direct drafting of templates or collaboration with assigned Contract Specialists
- Work directly with Project Manager and Sponsor to develop cohesive contract negotiation guidelines and parameters, escalation pathways, and establishment of Sponsor-specific signature requirements as applicable.
- Work directly with Project Manager, Grants Administration, Sponsor, and local Country Experts (including Contracts Specialists as applicable) to develop country-specific site budget templates, negotiation benchmarks, and escalation and fair market value assessment procedures and pathways.
- Responsible for accurate forecasting of site contract execution dates and communicating timelines to key stakeholders to ensure timely activation of study sites, including oversight of site contracts and budget status entries into study startup tracking systems and external trackers
- Collaborate with Contracts Specialists to resolve negotiation impasses with site contracts and budgets, including direct contract and budget negotiation with study sites when appropriate
- Conduct fair market value assessments of budget items that fall outside of negotiation benchmarks and as applicable to facilitate Sponsor approval or provide direct approval when authorized
- Serve as internal point of escalation to facilitate resolution of legal language negotiations, including approval of contract terms when authorized
- Responsible for maintaining and updating country-specific contract templates in assigned countries of oversight within the Clinical Contracts CTA template repository
- Supports the development and creation of contracts related departmental intelligence tools
- Serves as mentor to fellow Clinical Contracts team members to assist in departmental outstanding of complex contracts issues
- Serves as contracts-related subject matter expert within the department and in a cross-departmental capacity.
- May be called upon to conduct trainings
Supervisory Responsibilities:
No supervisory responsibilities.
Job Requirements: - Education
- BA/BS degree in a related field, an advanced degree is preferred
- Legal education background preferred (Paralegal certification or Juris Doctor)
- Experience
- Clinical research, contracts, or related experience that includes working in a team-oriented environment preferred
- Minimum of three years of contracts related experience is essential and experience in a CRO or pharma setting is strongly preferred
- Excellent understanding of contracting principles and requirements
- Familiary with budget development, benchmarking practices, and fair market value principles is required
- Skills/Competencies
- Proficient in general and regionally-specific contract fundamentals; successfully applies this knowledge to contract drafting, review, negotiation, and amendment processes.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment
- Good understanding of clinical trial process across Phases II-IV and ICH GCP Ability to interact effectively and appropriately with investigative site personnel
- Excellent organizational skills and attention to detail, with proven ability to handle multiple tasks effectively
- Analytical: be able to identify and understand site contract and budget issues in an early phase for the clinical trial and concisely convey the issue to the internal and client project team as well as draft a response to resolve the issue understanding the urgency. Ability to problem solve and work independently using own initiative
- Sound judgment: displays willingness to make decisions, exhibits sound and accurate judgment, and makes timely decisions.
- Planning/Organizing – Prioritizes and plans work activities, uses time efficiently, and develops realistic action plans. Demonstrates flexibility and willingness to learn new skills that are relevant to the position.
- Capabilities
- Windows; proficient in MS Word, Excel, Powerpoint. Experience in industry benchmarking tools such as GrantPlan or GrantsManager is an advantage
- Excellent organizational skills.
- Exceptional English written and oral communication skills, proficiency in other languages is an advantage
- Excellent personal interaction skills
The company will not accept unsolicited resumes from third party vendors.
