技能/経験

■Contract Specialist - Entry
Duties are performed with close supervision and guidance from supervisor. The employee should begin to develop a basic understanding of clinical research and site contract/budget negotiations .
• Bachelor’s degree;
• Proficient knowledge of Microsoft Office applications;
• Demonstrated time management skills; and
• Demonstrated oral and written communication skills.

■Contract Specialist I
The employee is experienced enough to coordinate contract and budget negotiations and manage activities day-to-day with minimal orientation and oversight. A rapid increase in knowledge and understanding of contract and budget negotiation and management is expected.
• Bachelor’s degree with 1 year of clinical research experience or Juris Doctorate/Advanced degree within the field of law, or Bachelor’s degree with at least 1 year of clinical research experience as Contract Research Associate or similar position with experience of drafting contract and/or budget including the knowledge of point table;
• Broad knowledge of clinical trial conduct, specifically, the preparation and maintenance of contracts and budgets; and
• Ability to interact with Medpace team members and investigative sites.

■Contract Specialist II
The employee is experienced enough to function independently on a day -to-day basis with minimal orientation or oversight related to core responsibilities. Some oversight may be necessary for certain assignments.
• Bachelor’s degree with 1 year of clinical research contract and budget negotiation experience (excluding time spent in an entry-level position in the industry) or Juris Doctorate/Advanced degree within the field of law or Bachelor’s degree with more than 2 years of clinical research experience as Contract Research Associates or similar position with experience of drafting and negotiating contract and budget including calculation of point table;
• Demonstrated ability to independently prepare, negotiate, and maintain contracts and budgets; and
• Ability to effectively interact with all Medpace team members and Sponsors on project - related issues.

■Contract Specialist III
Highly proficient individual in Site Contracts. Employee has enough experience that minimal project training is required. Expected to perform Contract Study Lead duties (e.g., task delegation and support for global studies, review contract / budget queries ) for moderately-sized projects as assigned. Employee is also expected to serve as mentor for more junior Contract Specialists.
• Bachelor’s degree and 3 years of clinical research contract and budget negotiation
experience or Juris Doctorate/Advanced degree within the field of law or Bachelor’s degree with more than 3 years of clinical research experience as Contract Research Associates or similar position with experience of drafting and negotiating contract and budget including calculation of point table;
• Demonstrates good judgment when making decisions; and
• Demonstrated ability to coordinate multiple assignments simultaneously in an accurate and on a timely basis.

■Contract Specialist Sr
A senior level position. Highly proficient in all Site Contract activities and processes . As necessary, this employee has the ability to successfully act as the Study Contract Lead on allocated studies and is also able to efficiently manage departmental projects. Expected to communicate independently with external clients, vendors and sites, while keeping line and study management informed regarding project-related activities. In addition, employee is capable of performing Contract Study Lead duties (e.g., task delegation and support for global studies, review contract / budget queries) for large global projects as assigned.
• Bachelor’s degree and 5 years of clinical research contract and budget negotiation experience or Juris Doctorate/Advanced degree within the field of law and 0.5 years of clinical research contract and budget negotiation experience or Bachelor’s degree with more than 5 years of clinical research experience as Contract Research Associates or similar position with experience of drafting and negotiating contract and budget including calculation of point table;
• Demonstrated ability to provide leadership and guidance to other Contract Specialists; and
• Demonstrated ability to support and augment department initiatives.
Manager
・Bachelor’s degree;
・At least 4 years of contract management experience in clinical research;
・Excellent communication, negotiation, and leadership skills; and
・Fluent in Japanese and English

◆Mental Demands
The degree and type of independent judgment and mental effort needed to solve problems associated with the job.
The employee will independently populate site or country spec ific contract templates, review negotiation responses, communicate negotiation parameters, manage follow up and tracking of contract and budget negotiation and signature process. The employee will be resp onsible for performing tasks as listed above in order to meet goals, timelines, and demands of Clinical Operations.