Contracts Lead in România

*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 talented and energetic *Contracts Lead* to join our team!We can consider hiring this role in any location in Europe where we have an office presence.The Contracts Lead is responsible for managing all aspects of implementing Confidentiality Agreements, Clinical Trial Agreements, Contract Amendments and other associated documents for assigned studies (“Site Contracts”). The Contracts Lead is responsible for ensuring high quality of all Site Contracts and that all documents comply with consistent standards and local legal requirements for assigned studies. The Contracts Lead is responsible for managing all steps of the process for initiation and completion of all Site Contracts in parallel with study start up timelines and site initiation projections. The Contacts Lead serves as the liaison with the client for reporting on the status and execution of all documents. The Contracts Lead will negotiate the terms of all Site Contract templates with each Sponsor at the beginning of each project, and serve as liaison between the sponsors and country experts in all negotiations. The Contracts Lead will assist the Manager of Site Contracts in development and maintenance of templates for CTAs, CDAs and other documents as needed and will review all such templates for compliance with local legal requirements and industry standards regularly.**ACCOUNTABILITY:****The Contracts Lead** * 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 Manager CMs 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 Manager or Premier’s Legal Counsel. * Proactively identifies site contract related risks and potential controversies or conflicts. * Participates in internal project-related meetings as needed. * Assists in development and implementation of new initiatives and processes in site contracts. * Collaborates with the start-up team to ensure the client deliverables and expectations are achieved. * Is the liaison with the client for CTAs/CDAs between the country level experts and the client for assigned studies   **RESPONSIBILITIES:** *For clinical success:* * Liaises with internal customers to review contract or budget areas that impact final execution of site contracts.*For commercial success:* * Ensures that Premier Research, clinical investigators, institutions and our clients have contractual agreements in place that are clear, fair and legally binding.*Other:* * Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to CDAs, 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.   **EDUCATION, SKILLS & COMPETENCIES:**   **Educational Background** * Undergraduate degree or its international equivalent in legal studies or life sciences from an accredited institution.  Law degree preferred.**Experience**  **Level 1 – Contracts Lead** * At least 1 year of legal experience with global contract language, budget development and negotiations. Preferably clinical study related. * At least 1 year of related industry experience (CRO preferred) * Ability to work with internal and external customers/vendors to meet project-specific goals * Interacts with clients and other functional areas as secondary project contact for contracting issues and questions * Manages time and project requirements base on study deliverables   **Level 2 – Contracts Lead II ** * Same accountabilities as Level 1 * At least 2 years of legal experience with contract language, budget development and negotiations * At least 2 years of related industry experience (CRO preferred) * Assist with mentoring and training staff * Provides input in local SOPs and WGs * Support for the creation of internal training materials   **Level 3 - Senior Contracts Lead  ** * Same accountabilities as Levels 1 & 2 * 3+ years of legal experience with contract language, budget development and negotiations.  Preferably clinical study related.  * Advanced legal training/course work preferred * Serves as Primary Liaison for clinical site contract management for a study or program   *Expertise and know-how*  * Knowledge of basic requirements of contracts, non-disclosure agreements, powers of attorney and related documents. * Knowledge of European Privacy Laws and regulations pertaining to cross border transfer of data. * Knowledge of ICH / GCP regulations * Working knowledge of FDA Guidance Documents / EU Directives / 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 as well as knowledge of cultural/professional practices appropriate to the country/region where the site start-up activities will be carried out.   **Personal skills &* behaviors* * Fluent verbal and written English as well as the local language(s) required for clinical trial submissions * Excellent team player, collaborative and able to build an effective team * Ability to multitask and work effectively in a fast-paced environment with changing priorities * Strong verbal and written communication and negotiation skills * Excellent organizational and time-management skills, able to prioritize work to meet deadlines * Accountable, dependable and demonstrates strong commitment to the role * Is customer service focused in approach to work, both internally and externally * Maintains a positive, results-orientated work environment   The above job description is intended to describe the key responsibilities but is not an exhaustive summary of all responsibilities, duties and skills that are required.  The company reserves the right to vary the job descriptions as per their requirements. All activities must be conducted in line with Premier Research Policies and Standard Operating Procedures, other standard procedural documents that are contractually agreed for a given activity and all nationally and globally applicable laws, Regulations and Guidelines.