Work Schedule

Environmental Conditions

Job Description

Essential Functions:

• Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process.
• Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes.
• Communicates, trains and provides approved contract templates, process and negotiation parameters and client expectations to assigned teams.
• Ensures collaboration, quality alignment with terms and conditions, process and client expectations with assigned team members.
• Identifies and assesses legal, financial and operational risks in accordance with approved company and client contractual considerations.
• Acts as a lead regional interface and escalation contact with external clients for term & condition revisions outside of approved negotiation parameters, client expectations and process deviations.
• Provides recommendations and alternative resolutions contracts negotiations to internal and external clients.
• Works with internal functional departments to facilitate coordination of different site startup activities impacted by contractual activities upon mutually agreed upon timelines.
• Completes tracking and reporting as required.
• Contributes to change initiatives within the department.
• Completes periodic quality reviews and peer feedback reports.
• May assist with training material preparation or delivery of training to team members.

Job Complexity: Management

Job Knowledge:  Administers and executes policies, processes, and procedures that affect subordinate employees and the workflow of the unit. Requires full knowledge of own area of functional responsibility.

Supervision Received: Directly supervises individual contributors, administrative support and / or entry-level professionals.

Business Relationships: Assignments are task or activity oriented. Work is reviewed for soundness of judgment and overall quality and efficiency. A portion of the time may be spent performing individual tasks.

Qualifications:

Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
• Demonstrated understanding of regional principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws
• Demonstrated ability to apply basic principles of investigator grant negotiation
• General understanding of business, contractual and financial principles that related to service agreements
• Effective communication skills (verbal & written) in English and in language spoken at your local place of work
• Capable of drafting and negotiating contract provisions and budgetary issues within parameters
• Demonstrated ability to attention to detail
• Excellent analytical and decision based thinking skills
• Demonstrated depth of knowledge and expertise in clinical drug development and trial process, attained within the pharmaceutical and/or CRO industry
• Able to work independently or in a team environment
• Excellent organizational and time management skills
• Working knowledge of PPD SOP & WPDs
• Able to organize competing priorities logically and review outstanding contractual risk and issues
• Ability to demonstrate a customer focused style of communication, problem solving and collaboration
• Able to effectively use automated systems and computer applications
• Flexible and able to multitask and prioritize competing demands/workload

Management Role:
No management responsibility

Working Conditions and Environment:
• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.

Physical Requirements:
• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.

Percent Billable: 80% - 100%