Contracts Manager
hace 7 meses
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.
**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
- 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 edu
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