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Site Contracts Lead
hace 2 semanas
Bring your Passion to Premier Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices.
We’re looking for a **Site Contracts Lead** to join our **Study Start Up** team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success. Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact in an aspiring, empowering and caring culture where people truly work as one team. You can grow and contribute your expertise with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it
**What you'll be doing**:
- Oversight of all Site Contracts with country experts during the process of investigator site negotiation for assigned studies.
- Support quality of all Site Contracts by reviewing and advising on request language and budget changes requested by investigator sites. Serve as liaison with Sponsor on management of sites’ requests for changes. Negotiate changes towards solutions to country experts.
- Establish templates as required for each new study by selecting appropriate template and tailoring for study requirements. Confirm suitability with Sponsor and establish negotiation parameters if possible. Confirm suitability of each template with local country experts, if necessary.
- Works with Premier Regulatory Submission Managers to provide final CTA and/or budget per country/site as needed for country regulatory submissions.
- Independently communicates with Premier Regulatory Submission Manager on all contract-related items as needed per study.
- Escalates legal questions/issues appropriately to Line Manager, Premier’s Legal Counsel or Sponsor.
- Proactively identifies site contract and budget related risks and potential controversies or conflicts and suggests solutions to resolve or mitigate those risks/controversies.
- Participates in internal and external project-related meetings as needed.
- Assists in development and implementation of new initiatives and processes in site contracts.
- Interacts with clients and other functional areas as secondary project contact for contracting issues and questions.
- Collaborates with Premier study team members, including the start-up team and Clinical Lead to ensure the client deliverables and expectations are achieved.
- Is the liaison with the client for CTAs/NDAs between the country level experts and the client for assigned studies.
- Represents Premier Research Contracts Department during internal and Sponsor Kick-Off Meetings.
- Participates in establishing study contract negotiation timelines at the beginning of the Study and oversees site contract related study timelines milestones, deliverables and deadlines throughout the course of the Study.
- Liaises with internal customers to review contract or budget areas that impact final execution of site contracts.
- Guides and helps Site Contract negotiators to successful completion of Study timelines and deadlines.
- Ensures that Premier Research, clinical investigators, institutions and our clients have contractual agreements in place that are clear, fair and legally binding. Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to NDAs, CTAs, investigator grants, and Letters of Authorization or Powers of Attorney.
- Provides training on clinical site contractual requirements and negotiation.
- Mentors and trains junior level staff.
- Participates in corporate initiatives and actions that ensure the continued success of the company.
- Provides performance feedback on project team members for annual appraisals.
- Other activities as designated.
**You'll need this to be considered**:
- Undergraduate degree or its international equivalent in legal studies or life sciences from an accredited institution. Law degree 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 related industry experience (CRO preferred)
- 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
