Senior Site Start Up Legal Contract Analyst

**Description**

**JOB TITLE: Senior SSU Legal Contracts Analyst**

**SELECT ONE: Clinical Development Services**

**JOB SUMMARY**:
**JOB RESPONSIBILITIES**
- Develops and shares expertise regarding sponsor processes, local country/site investigator contracts requirements within the team and BU.
- Subject matter expert equipped to help resolve global site contracting and legal issues arising from clinical trial set up activities.
- Develop and maintain of Company’s suite of investigator contract templates, confidentiality agreements, letter of authorization and improve associated processes and procedures around this documentation.
- Proposes contracting solutions to issues that may arise during a project or contract life cycle, to enhance negotiation strategy and ensure deliverables are met.
- Establishes site contract project strategies around language parameters to reflect sponsor's master service agreement terms and required processes.
- Identifies possible contract or process operational risk and proactively works to provide solutions. Establishes strong working relationships with customer and internal project teams. Escalates deviations to senior management and is equipped to resolve issues with Quality Assurance.
- Ensures site contract templates are drafted taking into consideration key operational aspects indicated in the relevant operational documents (e.g. protocol, pre-study visit report, etc.), as well as in the customer agreement documents at a project and organizational level.
- Establishes strong working relationships and collaboration with Sponsor to ensure site contract templates fit into the global strategy set for the program.
- Responsible for drafting, negotiating with Sponsor legal department or contract representatives and harmonizing site contract templates, site contract language, fallback templates and parameters, within Company processes and works closely with Company’s corporate Legal and other internal stakeholders to obtain any cross-functional input needed. Identifies risk areas for Company arising form site contracts and offer mitigation solutions to protect Company.
- Serves as main point of contact for the sponsor legal to legal escalations to obtain timely approval of changes outside of approved negotiation and provide solutions to broker execution of contract-related documents for a given study,
- Generates site contract documents of all variations, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions. Supports existing Company initiatives to streamline site contract negotiations.
- Creates and maintains document status reports and updates department team members on a regular basis; ensures appropriate documentation is maintained for all exceptions.
- Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
- Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

**Qualifications**

**QUALIFICATION & REQUIREMENTS**
- BS degree in life sciences and/or English, or equivalent combination of education and experience. Advanced and/or legal degree preferred.
- Extensive experience in a CRO and related contract management, legal and/or site start-up experience.
- Thorough knowledge of applicable regulations, drug development, and clinical project management procedures.
- Strong presentation, documentation, and interpersonal skills. Proficient in MS Office (Word, Excel, and PowerPoint),
- MS Project, outlook, and Internet. Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
- Strong background in issue resolution, meeting customer deliverables and driving best practices at organization or customer portfolio level

**Disclaimer**:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.