Italy Job Openings
Ora
Contract Specialist
Roma
November 27, 2024
POSITION TITLE: Contract Specialist
DEPARTMENT: Ora Europe
LOCATION: Remote in Italy
Ora Values the Daily Practice of …
Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor
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:
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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DEPARTMENT: Ora Europe
LOCATION: Remote in Italy
Ora Values the Daily Practice of …
Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor
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.
-
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.
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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.
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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.
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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 Do:
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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We regret to inform you that this job opportunity is no longer available as it has expired
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