Senior Study Start-Up Specialist

Essential Job Functions:

• Serves as designated point person on assigned studies.
• Attends Internal and Sponsor teleconferences and reports study start up status.
• Generates, gathers, and reports project metrics to project teams and/or line manager.
• Conducts routine hand-off activities between cross-functional teams.
• May provide operational oversight and/or supervision to Study Start Up (SSU) personnel with minimal oversight from the Line Manager, as directed.
• Provides training to SSU personnel and to Clinical Administration personnel as requested, as well as training Partners and Affiliate CROs participating in start-up activities.
• Serves as subject matter expert to assist Manager with development of WuXi Clinical department processes.
• Assists with communication and leadership within Clinical Study Start Up.
• Serves as Contract and Budget analyst, as required.
• Serves as project representative for internal and external audits, relative to study involvement, as required.
• Establishes tracking procedures for projects with minimal direction of manager.
• Maintains and updates project tracking tools, metrics, and computer databases.
• Generates, gathers, and reports project metrics to project teams and/or line manager.
• Assists with Master ICF development and review.
• Drafts and implements study-specific tools for use within Clinical Study Start Up to improve department efficiencies and timelines.
• Conducts secondary/independent/quality review of essential regulatory documents and Informed Consent Forms.
• Conducts routine hand-off activities between cross-functional teams.
• Contributes to overall operations and the achievement of departmental goals.
• Performs job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• Must work outside of regular office hours, as required (dependent on study needs).
• Performs other duties as assigned.

• Minimum of 5 years’ experience in clinical research environment (i.e., CRO or Pharma environment) managing administrative aspects of clinical trials or equivalent experience.
• High School diploma or equivalency required. Bachelor’s degree preferred.

• Must be familiar with the study budget allocation, and possess the ability to monitor personal time and personnel time working on study start up activities.
• Ability to multitask in order to adhere to strict timelines.
• Ability to make decisions that could have substantial impact on study start up and clinical administration issues.
• Must show ability to review regulatory documents in advance of quality assurance review with high-level of accuracy, make decisions on the quality of the documents, and take appropriate action.
• Must have excellent verbal and written communication skills in English and concise technical writing skills with minimal grammatical or logical errors. Ability to connect and effectively communicate with people from various backgrounds. Ability to teach effectively to other study start up and clinical administration staff .
• Proficiency with Microsoft Office Suite applications.
• Must have strong attention to detail and demonstrate understanding of the critical nature of WuXi Clinical documentation .
• Must have ability to initiate steps according to established processes without intervention.
• Must be able to solve problems independently and anticipate risks to the project within the scope of the position and to propose solutions .
• Ability to organize workload and handle multiple priorities, as well as train other Study Start-up staff on best practices and how to manage their time and schedules.
• Must have high-level of adaptability as task requirement and priorities change quickly.
• Less than 10% travel is required. Travel is primarily domestic and infrequently international. Daily and overnight travel are required.
• Must have a valid driver’s license and the ability to rent a vehicle as required.

Physical Requirements:

• Must be able to work in an office environment.
• Ability to stand or sit for most of the work day.
• Must be able to perform some activities with repetitive motion, such as keyboarding.
• Must be able to travel in various methods of transportation (i.e., car, airplane, shuttle bus, etc.).
• Must be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop.
• If working remotely, must have access to high-speed internet service and have knowledge and ability to resolve IT and computer related challenges through remote communications channels.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.