WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence) , for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.
Job Summary:The Senior Project Manager manages and coordinates clinical and/or data project services for sponsors to assure project/program milestones are met according to contract and applicable regulations are followed.
Essential Job Functions:
Provides operational support for Clinical Operations
Oversee all aspects of clinical research projects (primarily inclusive of complex, full-service and/or global trials) in order to assure applicable regulations, standard operating procedures and sponsor requirements are met
Perform contract and financial management activities for assigned trials and serve as central point of contact with sponsor for project updates
Serve as supervisor, resource, mentor, trainer, and motivator to team members
Participate in business development activities, including proposal development and pricing and bid defense meetings, as required
Meet with resourcing lead and supervisor to assure project needs are adequately met for all assigned projects
Perform training within company
High-quality deliverables, repeat business, and project profitability
Responsible for the management of US and Global projects
Position requires employee be aware of budget constraints and ensure that the team is informed of those constraints
Requires employee to monitor financials against those constraints in order to maximize project profitability
Mismanagement of project could result in poor project profitability, client dissatisfaction, and/or loss of repeat business
Gives formal supervision to Research Associates
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
Receives direct supervision from Associate Director, Clinical Operations or above
Demonstrates problem solving ability, taking into consideration time, financial, quality, and customer relations
Independently extrapolates and applies decisions from previous discussions to new situations and recognizes the relevance from one situation to the next
Requires only minimal supervision on project decisions that could have substantial impact on clinical, data quality, or regulatory issues
Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
Normally receives minimal instructions on routine work and detailed instructions on new assignments.
Works under close supervision from supervisor or senior personnel.
Performs support functions (e.g. Runner function) in the (fill in Specific Dept.)
Ability to work in a team environment and independently as required
May be required to work Holidays and weekends
May be required to work Overtime ( Remove only for Exempt positions)
Contributes to the overall operations and to the achievement of departmental goals
Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations [List as appropriate and could also go under KSA's below]
Other duties as assigned
May be required to assist in other departments
Experience / Education:
Minimum of 5 years related clinical research experience in CRO, pharma, biotech/device company with 3 years of project management experience or equivalent
Minimum of 3 years' experience directly managing professional level individuals
Experience in leading multi-service project teams through a complete clinical trial
Good knowledge of clinical, regulatory, and data aspects of trials including, but not limited to field monitoring, data management, biostatistics, and medical writing
Bachelor's degree preferred
Knowledge / Skills / Abilities:
Effectively communicates in clear, concise, professional manner with employees and senior management within company and with peer and senior level customer contacts
Communicates well both verbally and in writing and effectively conveys issues and potential resolutions to team members and supervisors
Demonstrates active listening and excellent interpersonal communication skills and exhibits the ability to lead team using appropriate motivational techniques, conflict management approaches, and consistent integrity
Skilled at presenting topics to groups for the purpose of training, bid defense meetings or other public speaking opportunities
Good working knowledge of physician care in hospitals, clinics, or other healthcare settings
Advanced knowledge of FDA guidelines and review processes, IND and NDA processes, and GCPs; project management skills including client management, fiscal/contract management, and quality management; as well as strong time management skills and the ability to thrive in a stressful environment with multiple priorities
Demonstrates a high level of attention to detail and the ability to interact professionally with clients, team members, and investigational sites
Solid knowledge 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, etc.)
Travel is required 10% , Domestic/International, Daily / Overnight
Must have a valid driver's license and the ability to rent a car
Must be able to work in an office environment, which has minimal noise conditions
Ability to stand or sit for most of the work day
Must be able to perform some activities with repetitive motion, such as keyboarding
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.
WuXi AppTec requires all employees, both Field and Office-based, to be fully vaccinated with a COVID-19 vaccine by February 9, 2022 or undergo weekly COVID-19 testing as set forth in WuXi AppTec's Mandatory COVID-19 Vaccination Policy, unless they are eligible for an exemption from the vaccination or testing requirements based on a disability or sincerely held religious belief, practice or observance. If you are offered employment with WuXi AppTec, you will be required to provide acceptable proof of your COVID-19 vaccine (if applicable) no later than 8 days before your first day of employment.
WuXi Clinical is 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.