Overview

WuXi Clinical, a full service CRO, is hiring a Senior Clinical Project Manager to manage and coordinate clinical and/or data project services for sponsors to assure project/program milestones are met according to contract and applicable regulation are followed. Responsible for the management of US and global projects. Serves as resource, mentor, and motivator to team members, as required. Responsible for managing overall study budget and identifying budget constraints. Provides leadership and coordination to matrix team members.

Responsibilities

Essential Job Functions:

• Provides operational support for clinical operations in the US and globally.
• Oversees all aspects of clinical research projects (primarily inclusive of complex, full-service, and/or global trials) to assure applicable regulations, standard operating procedures, and sponsor requirements are met.
• Performs contract and financial management activities for assigned trials and serves as central point of contact with sponsor for project updates.
• Serves as supervisor, resource, mentor, trainer, and motivator to team members.
• Participates in business development activities, including proposal development and pricing and bid defense meetings, as required.
• Meets with resourcing lead and supervisor to assure project needs are adequately met for all assigned projects.
• Provides high-quality deliverables to ensure project profitability and repeat business.
• Maintains and manages overall study budget and identifies and informs team of budget constraints.
• Maintains frequent contact with client team at all levels of management via team calls, ad hoc meetings, presentations, and emails.
• Responsible for the implementation of change orders and scope of work changes.
• Identifies study risk and develops mitigation strategies and contingency plans.
• Provides leadership and coordination to matrix project team members that may include clinical research associates, clinical data analysts, vendors, contractors, and consultants as required by the project.
• Performs job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• Manages and provides supportive functions to vendors, sites, and clients.
• Must work outside of regular office hours, as required (dependent upon study needs).
• Performs other duties as assigned.

Qualifications

Experience / Education:

• Bachelor's degree in a Pharmacy, Medicine, Life Sciences, Nursing, or equivalent experience.
• Minimum of 5 years of project management experience with a CRO, pharmaceutical, biotechnology/device company.
• Minimum of 3 years of experience directly managing professional-level individuals.
• Experience with clinical, regulatory, and data aspects of trials, including but not limited to field monitoring, data management, biostatistics, and medical writing, within the clinical research global environment.
• Must have a comprehensive understanding of and experience abiding by FDA Guidelines, ICH, GCP, NDA, IND, and other applicable regulations.
• Experience with successfully presenting topics to groups for the purpose of training, bid defense meetings, or other public speaking opportunities.
• Previous experience managing global studies is preferred.

Knowledge / Skills / Abilities:

• Proficient with the use of computers and Microsoft Office Suite of products, as well as experience with tools specific to clinical trial management (e.g., CTMS, EDC, IVRS, eTMF, financial management systems, etc.)
• Project management skills must include client management, fiscal/contract management, project financial projections, and quality management, as well as strong time management skills and the ability to thrive in a complex environment with multiple priorities.
• Ability to lead multi-service project teams through a complete clinical trial.
• Ability to lead team using appropriate motivational techniques, conflict management approaches, and consistent integrity.
• Demonstrates a high level of attention to detail and the ability to interact professionally with clients, team members, and investigational sites.
• Ability to monitor project financials against those constraints to maximize project profitability.
• Ability to solve problems and take into consideration time, financial impacts, quality, and customer relations when making decisions.
• Working knowledge of physician care in hospitals, clinics, or other healthcare settings.
• Proficient oral and written communication skills in English are required.

• Ability to work in satellite environment independently but remain engaged with home office and supervisor. This is an office position with the flexibility to work remotely as agreed upon with the supervisor.
• 10 - 20% 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, which has minimal noise conditions.
• Ability to stand or sit for most of the workday.
• 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.