Senior Site Contract Associate

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

📋 Description

• Assist in executing all necessary start-up contracting activities for designated sponsors, studies, or multi-protocol programs as specified by the established algorithm or the Sponsor’s specifications, including pre-award tasks.

• Create basic investigator grant estimates and proposal content to aid in the proposal development procedure.

• Utilize and uphold contract and budget templates, along with contracting systems, tools, processes, and training materials for designated sponsors, studies, or multi-protocol programs in alignment with the Scope of Work and Project Plan, adhering to the agreed project strategy.

• Foster collaboration through effective communication with sponsors, stakeholders, and RSU regions and countries to successfully fulfill the agreed project scope while complying with sponsor specifications and/or the RSU Management Plan.

• Offer specialized operational and financial contracting assistance to streamline business development and the initiation and management of clinical trials, while ensuring adherence to regulatory requirements.

• Aid in the development and/or review of essential scientific, technical, and administrative documentation to support business development and facilitate study initiation and maintenance, as needed.

• Contribute to the gathering, interpretation, analysis, and dissemination of precise contracting intelligence to support assigned studies and the broader organization, as necessary.

• Ensure overall contracting efficiency and compliance with project timelines and financial objectives; report on contracting performance metrics and any out-of-scope contracting activities as required.

⛳️ Requirements

• Bachelor's Degree in life sciences or healthcare.

• Over 6 years of relevant experience, including proven experience as a contract negotiator.

• Experience in clinical site contracting within a sponsor or clinical research organization.

• Strong negotiation and communication skills.

• Excellent interpersonal skills and a collaborative team player.

• Proficient technical writing abilities.

• Familiarity with the regulated clinical trial environment and understanding of the drug development process.

• Knowledge of and ability to apply GCP/ICH and relevant regulatory guidelines.

• Awareness of applicable regulatory requirements, SOPs, and the company’s Corporate Standards.

• Strong organizational and planning skills.

• Proficient knowledge of Microsoft Office and email applications.

• Ability to interpret pricing models and prepare proposals, bid grids, and budgets.

• Good understanding of clinical trial contract management.

• Capability to establish and sustain effective working relationships with colleagues, managers, and sponsors.

🏝️ Benefits

• Adhere to contract management and quality standards.

• Provide administrative and operational assistance to investigator site contract analysts, managers, and directors as necessary.

• Ensure the accurate completion and upkeep of internal systems (with a focus on CTMS), databases, tracking tools, timelines, and project plans.