We’re looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with. 

Overview

Support the negotiation and execution of clinical trial site agreements and budgets for awarded studies in accordance with Lexitas SOPs and procedures.

Responsibilities

• Negotiate site Clinical Study Agreements (CSAs) and budget templates based upon study parameters
• Develop investigator grant estimates and proposal text to support the proposal development process.
• Draft and negotiate Confidential Disclosure Agreements (CDAs)
• Utilize and maintain contract and budget templates and contracting systems, tools, processes, and training materials for selected studies according to the Scope of Work and Project Plan, within the agreed project strategy.
• Ensure collaboration, including communication with sponsors, partners, and stakeholders to successfully deliver the agreed project scope in compliance with sponsor requirements and/or Project Management Plan
• Provide specialist operational and financial contracting support to facilitate efficient business development and initiation and maintenance of clinical trials, while enabling compliance with regulatory requirements.
• Ensure overall contracting efficiency and adherence to project timelines and financial goals; report contracting performance metrics and out of scope contracting activities as required.
• Ensure accurate completion and maintenance of internal systems (CTMS), databases, tracking tools, timelines and project plan
• Engage in learning updated contracting processes and procedures to facilitate faster and more accurate contract negotiation, including acceptance of guidance and critiques to facilitate such learning
• Ensure timely completion of trainings required for this position

Requirements

Education:

• Bachelor-level degree along with one year of contracting experience or an equivalent combination of education and experience, including demonstrable experience acting as a contract negotiator.
• An Associate-level degree with three years of contracting experience, or an equivalent combination of education and experience, including demonstrable experience acting as a contract negotiator.

Experience:

• Advanced English level
• Strong negotiating and communication skills.
• Strong organizational and planning skills.
• Strong interpersonal skills and a team player.
• Understanding of regulated clinical trial environment and knowledge of drug development process.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Solid understanding of clinical trial contract management.
• Experience working with or at research sites perferred

Skills:

• Highly customer-service oriented.
• Quality of interactions demonstrates an emphasis on developing and retaining strong relationships internally and externally.
• Ability to work with confidential, sensitive information
• Excellent verbal and written communication skills.
• Strong attention to detail.
• Ability to plan and organize information and activities on behalf of the Study Manager with direction and oversight as needed
• Able to work in a fast-paced environment
• Ability to successfully and independently prioritize workload and adapt to changing priorities. 
• Proficiency in some software system(s) as appropriate for the needs of the department.   
• Possesses active listening skills and proactively provides updates and information based on independent judgement and interpretation of needs.
• Works well as part of a dynamic project team, actively supporting other team members and identifying opportunities to lead and contribute.

Physical Requirements

Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., 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. Lexitas Pharma Services, Inc., 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.