Senior Specialist

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Develop, review, and assist in the negotiation of Site Agreements with institutions and investigators.

• Provide oversight and expertise on site contract activities throughout clinical trials.

• Create investigator grants, Clinical Trial Agreement templates, and relevant plans.

• Prepare country-specific contract templates.

• Draft and distribute Site Agreements and related contracts for negotiation purposes.

• Offer execution timelines and updates on site negotiation status.

• Coordinate the translation of contract materials when necessary.

• Review study budgets and costs associated with contract negotiations.

• Negotiate contract terms and budgets until finalization and execution.

• Escalate requests that fall outside preapproved parameters, risks, and non-responsive sites.

• Include equipment details or appendices in Site Agreements when necessary.

• Prepare donation agreements and termination letters as required.

• Ensure contracts are complete and accurate through thorough review.

• Finalize contracts and budgets with sites.

• Conduct quality checks prior to signature processes.

• Supply contracts and budgets to regulatory teams for submissions as needed.

• Liaise with legal, data privacy, study teams, sponsors, sites, investigators, and other stakeholders.

• Facilitate the signing of contracts.

• Distribute executed agreements to sites, eTMF, payment teams, sponsors, and internal SharePoint.

• Maintain real-time tracking tools for contract management.

• Review TMF structure and oversee Investigator Grants Budgets.

• Serve as the lead and subject matter expert on site agreements and related processes.

• Coordinate master budgets, contract plans, and budget strategies.

• Communicate contracting strategies, timelines, and tracking requirements effectively.

• Develop mitigation plans, resolve negotiation challenges, and contribute to process enhancement initiatives.

• Perform additional duties as assigned.

⛳️ Requirements

• 3 to 5 years of experience as a Contract Specialist within the clinical research, pharmaceutical, or Contract Research Organization sectors.

• Bachelor's degree or equivalent in Business Administration, Finance, Science, or a related discipline.

• Exceptional verbal and written communication skills in English.

• Proficiency in Microsoft Word, Excel, and Outlook.

• Knowledge of the International Council for Harmonisation (ICH) and Good Clinical Practice (GCP) Guidelines.

• Familiarity with local country legislation pertaining to clinical trials and local regulatory requirements.

• Advanced skills in contract negotiation.

• Expertise in negotiating complex contract terms with clinical sites and vendors.

• Understanding of both international and local regulatory requirements for clinical trials, including FDA, EMA, and ICH-GCP standards.

• Proficient in utilizing contract management software and tools.

• Knowledge of budgeting and financial principles relevant to clinical trial contracts.

• Basic understanding of legal terminology and contract principles.

• Strong project management, analytical, time management, and problem-solving abilities.

• Capability to manage multiple site contracts, timelines, risks, and deliverables effectively.

• Ability to work efficiently within cross-functional teams.

• Capacity to handle high volumes of work and perform under pressure.

🏝️ Benefits

• Competitive benefits package based on location.

• An inclusive and equitable workplace environment.

• Transparent compensation practices.

• Commitment to pay equity and compensation transparency.