Site Contracts Lead (4 Month Contract)

Overview

This role is a 4-month contract position supporting the Regulatory Submissions and Contracts team. The position focuses on oversight and quality of site contracts during investigator site negotiation for assigned studies, including template development, timeline management, negotiation support, and escalation of legal questions.

Responsibilities

• Oversee site contracts with country experts during investigator site negotiation for assigned studies.
• Support quality of site contracts by reviewing and advising on request language and budget changes from investigator sites.
• Serve as liaison with the sponsor on the management of sites’ requested changes, negotiating toward solutions with country experts.
• Establish templates for new studies by selecting appropriate templates and tailoring for study requirements; confirm suitability with the sponsor and establish negotiation parameters where possible.
• Confirm suitability of each template with local country experts, if necessary.
• Work with Regulatory Submission Managers to provide final CTA and/or budget per country/site as needed for country regulatory submissions.
• Independently communicate with the Regulatory Submission Manager on contract-related items as needed per study.
• Escalate legal questions/issues to the line manager, Legal Counsel, or sponsor as appropriate.
• Proactively identify site contract and budget risks, potential controversies, or conflicts; suggest solutions to resolve or mitigate risks/controversies.
• Participate in internal and external project-related meetings as needed.
• Act as a secondary project contact for contracting issues and questions with clients and other functional areas.
• Collaborate with study team members, including the start-up team and Clinical Lead, to help ensure client deliverables and expectations are met.
• Liaise between country-level experts and the client for CTAs/NDAs for assigned studies.
• Participate in establishing study contract negotiation timelines at the beginning of the study; oversee site contract study timelines, milestones, deliverables, and deadlines throughout the study.
• Liaise with internal stakeholders to review contract and budget areas that impact final execution of site contracts.
• Guide and support site contract negotiators to successful completion of study timelines and deadlines.
• Ensure contractual agreements among the organization, clinical investigators, institutions, and clients are clear, fair, and legally binding.
• Review and advise on Regulatory and Clinical Operations SOPs, WGs, and ADs related to NDAs, CTAs, investigator grants, and Letters of Authorization or Powers of Attorney.

Requirements

• Undergraduate degree or its international equivalent in legal studies or life sciences from an accredited institution; a law degree is preferred.
• At least 2 years of legal experience with global contract language, budget development, and negotiations (preferably clinical study related). An advanced degree will be considered in lieu of a portion of industry experience.
• At least 1 year of CRO experience.
• Ability to work with internal and external customers/vendors to meet project-specific goals.
• Knowledge of basic requirements of contracts, non-disclosure agreements, powers of attorney, and related documents.
• Knowledge of privacy laws and regulations pertaining to cross border transfer of data.
• Knowledge of ICH / GCP regulations.
• Working knowledge of FDA Guidance Documents / EU Regulations / Local Regulations / ISO14155 regulations, drug/device development, and clinical monitoring procedures.
• Knowledge of web-based communication tools for conferences and any other IT systems required for the job.
• Knowledge of national/local health systems and knowledge of cultural/professional practices appropriate to the country/region where site start-up activities will be carried out.
• Excellent collaboration skills and ability to build an effective team.
• Ability to multitask and work effectively in a fast-paced environment with changing priorities.
• Ability to manage time and project requirements based on study deliverables.
• Strong verbal and written communication and negotiation skills.
• Excellent organizational and time-management skills; able to prioritize to meet deadlines.
• Accountable, dependable, and demonstrates strong commitment to the role.
• Customer service focused approach to work, both internally and externally.
• Maintains a positive, results-oriented work environment.

Compensation & Benefits

• This is a 4-month contract position.

Location

• Not specified in the provided job description.

Equal Opportunity

• The employer is an equal opportunity employer and is compliant with all federal guidelines. All qualified applicants receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.