Contract Specialist

POSITION TITLE: Contract Specialist

DEPARTMENT: Ora Europe

LOCATION: Remote in UK, Spain, Italy or Poland

Ora Values the Daily Practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

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At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.

The Role:

The Contract Specialist plays a pivotal role in overseeing the negotiation and preparation of contracts and related documents for participation in industry-sponsored clinical trials. This role involves producing site-specific contracts from country clinical trial agreement (CTA) templates, negotiating budget and contract terms with sites and sponsors. Additionally, the role entails serving as a liaison between Clinical Operations, Project Management, Legal, and external stakeholders to facilitate efficient contract execution and compliance.

What You'll Do:

• Produce site-specific contracts from country CTA templates, review and own site-specific contracts, and submit proposed CTAs for site review.
• Build country-specific CTA templates, liaising with Legal, Clinical Operation, Regulatory and other relevant stakeholders.
• Perform quality control and arrange execution of CTAs, ensuring completeness and accuracy of contracts and documenting corrections as needed.
• Build and own timelines for execution of CTAs for sites at study level in collaboration with Project Management, Clinical Operations and Regulatory.
• Develop, own and maintain metrics for CTAs execution at the country and site level.
• Act as a liaison between the CRO, clinical trial sites, sponsors, and other stakeholders, facilitating effective communication to address issues and ensure smooth contract execution.
• Maintain accurate records of contract-related activities, track contract status, updates, and amendments using contract management systems.
• Contribute to the development and implementation of best practices for site contract management, streamline processes, improve efficiency, and enhance communication protocols.
• In partnership with Legal, serve as a clinical trial contract process expert, offering expertise on the regulatory and process intricacies concerning clinical trial contracting within the region.
• Ensure the quality and accuracy of all contract-related documents and processes, maintain compliance with internal SOPs and guidelines, and implement corrective actions when necessary.
• Identify and address potential issues proactively, formulating contingency plans as needed.
• Participate in client, investigator, and team meetings, prioritizing and responding to urgent requests.
• Adhere to all aspects of Ora's quality system.
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements.
• Clear and sustained demonstration of Ora's values - prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
• Responsibilities may differ from the above based on the specific needs of the business.

What We Look For:

• Experience needed for the Role:
  • Bachelor's degree in a relevant field or equivalent work experience required.
  • Minimum of 5 years of experience in contract management including substantial experience contracting across multiple European countries in the clinical research or pharmaceutical industry.
• Additional Skills and Attributes:
  • Strong negotiation, diplomacy, leadership, and organizational abilities.
  • Ability to work effectively in a fast-paced environment, prioritize tasks, and meet deadlines.
  • Proficiency in legal language interpretation, budget management, and GCP/ICH requirements.
  • Demonstrated problem-solving, analytical, and communication skills.
  • Track record of exceeding goals, partnering effectively with others, and continuous improvement mindset.
  • Detail-oriented with strong organizational and problem-solving abilities.
  • Proficiency in using contract management systems and MS Office suite.
  • Fluency in both written and spoken English; additional language skills may be preferred for specific regions.

Competencies and Personal Traits:

• What We Do:
  • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
• How We Do It:
  • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
  • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
• Why We Do It:
  • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.

What We Offer:

• Financial: Competitive salaries along with a structured pension plan.
• Well-Being: Offering private medical insurance healthcare beginning day 1 provided by Vitality and SimplyHealth.
• Company Paid Life & Disability Insurance: Offering peace of mind through Canada Life to help you and your family feel secure.
• PTO: 25 days of annual leave + Birthday PTO + bank holidays.
• Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
• Career Development Opportunities: Continued opportunities to grow and develop your career journey.
• Global Team: Opportunities to work with colleagues across the globe.
• Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.

Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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