Overview

The Oncology Clinical Team Manager (CTM) provides management of Oncology Clinical Research Associates (CRA) and clinical project services to assure project / program milestones are met and applicable regulations are followed. Ensures CRA resources are trained and given developmental opportunities that result in consistently high performing, knowledgeable and productive monitoring services that meet the flexibility and needs of sponsors and WuXi Clinical. This is an office or remote based position and requires approximately 30-40% travel.

Responsibilities

• Provides operational support for Clinical Operations.
• Responsible for management of CRAs and retention of high-quality clinical staff
• Ensures performance and regulatory compliance by CRAs through regular one on one CRA meetings and other training programs, ongoing performance evaluations and / or assessment visits, and review of work produced.
• Coordinates and leads quarterly CRA team meetings or as needed
• Serves as primary corporate contact and coordinator for all WuXi Clinical oncology monitoring activities including marketing initiatives to help grow the database of contract personnel, expand the client base, and cultivate repeat business from existing sponsors.
• May serve as Lead CRA on projects as needed and ensures successful implementation of monitoring strategies for all projects that include monitoring services.
• Attends team calls for oncology studies to provide support and guidance to the team for monitoring activities.
• Participates in proposal development and proposal presentations, as needed.
• Coordinates project assignments for CRAs with Project Managers and Directors to assure needs are addressed and clinical personnel are properly utilized.
• Maintains and provides resource planning forecasts on a routine basis.
• Serves as the Clinical Operations subject matter expert for all WuXi Clinical Standard Operating Procedures (SOP) and Work Instructions (WI); participates in the bi-annual review of SOPs/WIs and all associated forms and templates; revises and/or creates new SOPs/WIs as needed.
• Serves as the subject matter expert for Clinical Operations systems with regards to monitoring (i.e., Clinical Trial Management Systems); develops and maintains "How to" guides to aid CRAs in effective use of the systems per WuXi Clinical business practices.
• Normally receives minimal instructions on routine work and detailed instructions on new assignments. Works without close supervision from supervisor or senior personnel
• Performs job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Clinical Policies and Standard Operating Procedures.
• Other duties as assigned; may be required to assist in other departments.

Qualifications

Experience / Education:

• Bachelor's degree in Biological Sciences, Pharmacy, Nursing, Life Sciences & Chemistry or equivalent experience preferred.
• Minimum of 5 years as a CRA
• Minimum of 5 years of direct oncology experience
• Management experience preferred, including dealing with employee performance issues, evaluations, training, and development of staff.
• Thorough understanding and experience with oncology studies, oncology sites and current or previous experience as an oncology CRA
• Experience with study budgets and CRA oversight preferred.

Knowledge / Skills / Abilities:

• Must show ability to problem solve complex issues impacting multiple variables including quality, timing, sponsor, employee, regulatory, budget, and management concerns.
• Ability to work independently in a fast-paced environment and apply decisions from previous discussions to new situations.
• Demonstrated ability to use sound judgment on project, people, budget, and management decisions that can have substantial impact on employees, operations, revenue, profit, or regulatory issues.
• Positive and professional demeanor in oral and written communications with team, investigative sites, sponsors, WuXi Clinical management team, and others.
• Ability to effectively communicate issues and potential resolutions.
• Must exhibit excellent technical writing skills and good presentation skills.
• Ability to work in a team environment and / or independently as required.
• Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations.
• Demonstrated project management skills including cost control, quality controls and risk.
• Effective interpersonal skills and exhibit ability to lead team using appropriate motivational skills, conflict management, decision making, and integrity.
• Must have high level of attention to detail and must have ability to deal professionally with sponsors, team members & investigational sites.
• Expected to have good working knowledge of physician care in hospitals, clinics, or other healthcare settings; strong time management skills; and ability to thrive in fast paced environment with multiple priorities.
• Solid knowledge of computers and Microsoft Office Suite of products necessary
• Approximately 30-40% travel required; primarily domestic, infrequently international, daily / overnight.
• May be required to work holidays and weekends.

Physical Requirements:

• Must be able to work in an office or medical site.
• 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

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

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.