Overview

Join us in a key role driving forward essential initiatives within our dynamic Clinical Development team. You will play a crucial part in advancing Celldexs clinical program, taking charge of the seamless execution of vital clinical contracts and budgets that are integral to our mission.

Responsibilities

• Independently negotiates initial or amended site Clinical Trial Agreements (CTAs) and budgets, and/or serves as escalation point and oversight for CROs negotiating site CTAs and budgets on Celldexs behalf in support of assigned global Clinical Studies.
• Independently negotiates other initial or amended clinical Agreements such as Investigator Initiated Research Agreements (IIRs), Confidential Disclosure Agreements (CDAs), Consulting Agreements, as well as Vendor Agreements such as Master Services Agreements (MSAs), Statements of Work (SOWs), and Change Orders (COs).
• Ensures appropriate Data Privacy language is included in applicable ex-US contracts per GDPR guidance
• Oversees CRO development and review/approval of country-specific site CTA and budget templates
• Liaises with legal, manager, and study team members as necessary to ensure contracts and budgets are finalized, executed, logged and filed in accordance with Celldex standards and within the timeline needed to meet key company milestones
• Tracks ongoing projects and maintains supporting documentation for MGC role
• Gathers, populates, and oversees the review of monthly accrual data for assigned clinical studies and liaises with Clinical Operations and Finance to ensure accurate financial reporting with supporting documentation. Delivers rationale for study-specific approaches in collaboration with team.
• Attends meetings with finance, clinical operations, study teams, CROs, manager, and other internal or external parties to ensure full understanding of assignments including overall timelines and deliverables. Represents grants and contracts function as assigned and provides status updates, notes any gaps in contractual coverage or new items needed based on project status or changes.

Qualifications

• Bachelors or Associates Degree preferred. In lieu of a degree, 5 + years of relevant experience will be considered.
  • Paralegal certification is a plus
• At least 1 year relevant experience directly negotiating clinical site and vendor contracts and budgets, experience negotiating ex-US contracts a plus
• 3+ years in a clinical development or clinical operations team with a pharmaceutical company, CRO, or investigator site
• Understanding of healthcare compliance and other relevant guidance including GCP, HIPAA, FCPA
• Experience with EU GDPR guidance and negotiating data privacy terms a plus
• Strong computer skills including Word, Excel, Teams, and Sharepoint
• Ability to review tracked changes and comments from multiple reviewers within a document and collate, rewording as appropriate before returning to external parties
• Ability to manage workload independently and the agility to prioritize more urgent tasks based on project timelines, company goals, and manager directives
• Resourceful and adaptable in areas of ambiguity, but knows when to ask questions to gain context or escalate issues as appropriate
• Excellent analytical and problem-solving skills, takes ownership of assignments and initiative to move tasks forward and propose solutions to obstacles