Summary: Leads the contract development process with clinical research and development sponsors, vendors, consultants, and facilitates the negotiation process. Responsible for managing ProSciento's legal documents, as well as maintaining and improving ProSciento's repository of contract templates in consultation with BC Leadership and outside counsel. Negotiates improvements in contractual parameters, and as applicable in collaboration with BC Leadership and external advisors, defines and sets negotiation parameters in the best interest of ProSciento. Reviews, negotiates and provides risk assessment for internal contracts at ProSciento. Performs duties in accordance with ProSciento's values, policies, and procedures.

Essential Duties and Responsibilities include the following. Other duties may be assigned at the company's sole discretion.

• Accurately and with attention to detail leads and contributes to the timely development of high-quality contracts/agreements.
• Provides legal support and negotiates as needed contracts including but not limited to confidentiality agreements, Master Services Agreements, Clinical Trial Agreements with vendors, clients, and consultants, ensuring that the agreements are aligned with ProSciento's interests.
• Drafts amendments with vendors, clients, and consultants.
• May support with the negotiations with the sites.
• Manages and resolves contracting issues between ProSciento and its clients, , vendors and other potential business partners/parties to a business agreement/contract.
• Responds to inquiries from vendors, and sponsors professionally, efficiently, and effectively, and follows up with internal team members concerning outstanding contracts and budgets on as-needed basis, and as frequently as necessary to resolve any concerns/issues as quickly as possible.
• Produces high-quality, error-free legal documents for final execution.
• Prioritizes daily activities according to importance and urgency.
• Manages documents from creation to completion.
• Maintains updated information of all study related information to use as reference in daily duties.
• Stays abreast of changes in studies and/or updates to study/project specific scope of work or client preferences.

• Fosters team building, positive communication, and corporate culture. Maintains a positive working environment, developing and maintaining excellent relationships with colleagues and clients.
• Oversees contracting projects: reviews, evaluates, defines, and executes plans to develop contracts/agreements in support of ProSciento's business goals.

• Responsible for being up to date with regards to all applicable regulations, industry contracting standards/best practices, and can implement all applicable regulations, standards, and changes into practice at ProSciento.

• Reviews and provides risk assessment for internal contracts at ProSciento.
• Engages in process-improving activities and templates development.

• Participates in department and company meetings and may initiate meetings with the goal to improve BC processes and/or to align on project specific contractual terms and negotiations.
• Maintains and improves ProSciento's legal documents templates database.
• Develops negotiations parameters for a variety of contracts.
• Solves problems at a strategic level and provides risk assessments for the agreements as need to the internal team.
• Manages special projects as necessary, independently determining methods and procedures on new assignments.

Competencies:

• Dealing with Ambiguity: Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty.
• Business Acumen: Knows how businesses work; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.
• Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets firsthand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
• Negotiating: Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can win concessions without damaging relationships; can be both direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing.
• Priority Setting: Spends his/her time and the time of others on what's important; quickly zeros in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.
• Problem Solving: Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience:

Bachelor's degree in legal or Paralegal Studies or Paralegal certificate; JD preferred. 3-4 years' contract associate experience in a clinical research setting, and/or an equivalent combination of education and experience is a must. Experience in contract administration, procurement, or vendor negotiation required.

Skills, Knowledge, and Abilities:

Must have knowledge of regulations as they relate to clinical research. Attention to detail required in a highly regulated industry. Ability to work independently and be a proactive team player is required. Ability to proofread and detect errors in typing, spelling, grammar, syntax, and punctuation required. Knowledge of medical terminology preferred.

Language Ability:

Ability to read and interpret documents such as safety rules, Standard Operating Procedures (SOPs), Work Instructions (WIs), procedural manuals, governmental and clinical regulations, and similar documents. Able to communicate effectively to employees, cross departmentally, in management groups and group meeting settings.

Computer Skills:

To perform this job successfully, an individual should have excellent computer skills with working knowledge and proficiency in the current Microsoft Word, Excel, and Outlook as well as Windows applications.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to outdoor weather conditions. The noise level in the work environment is usually moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stoop, kneel, crouch, or crawl.

The above job description does not imply these outlined duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.

ProSciento reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and company.

ProSciento is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.