Thermo Fisher Scientific is a leader in serving science, committed to improving patient health through innovative laboratory services. The Project Manager will coordinate and manage clinical trials, ensuring successful project completion while maintaining quality and operational standards.
Coordinates and manages clinical trials from start up through close out activities.
Directs the technical and operational aspects of the projects, securing the successful completion of clinical trials.
Identifies and evaluates fundamental issues on the project, interprets data on issues, makes sound business decisions and ensure solutions are implemented.
Ensures all project deliverables meet the customer/contract expectations, providing accurate hour forecasts, reviewing pass-through costs and ensuring timely invoicing while working in collaboration with other functional area leads.
Manages allocated studies according to timelines and quality standards.
Coordinates activities of all functional departments and vendors involved in the project.
Works with team and management to develop plans/guidelines for project implementation using PPD tools.
Monitors and analyzes project status to ensure successful completion of project parameters, milestones, timetables.
Acts as liaison between Sponsor and PPD by facilitating the flow of information between PPD and client.
Provides Sponsor with timely project updates, project related fiscal information, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work.
May discuss and obtain feedback from Sponsors regarding PPD’s performance to date.
Plans and communicates to team members study specific tasks and priorities for projects.
Liaises with managers in all functional areas within PPD to optimize Performance and utilization of the project team members.
Appropriately escalates any issues or potential issues to management for all project related issues.
Works closely with other departments to manage financial and contractual aspects of the study including establishing and recognizing financial milestones for invoice and subcontractor purposes, subcontracting with third-party service providers, approving subcontractor invoices, and establishing proper accrual for investigator grants.
Works with the project team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets.
Ensures that appropriate assessment and coordination of project/protocol specific and therapeutic area training needs and activities are occurring for the team members as needed.
Qualification
Required
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience.
Knowledge of the key principles of cross functional project management (Time, Quality, Cost)
Fundamental financial acumen
Displays effective communication skills (listening, oral, written) and can communicate in English language (oral, written)
Sound interpersonal skills, is flexible and adapts to changing situations
Ability to persuade, convince, and influence or impress others
Organized, proficient at multitasking with good attention to detail
Ability to delegate, effectively prioritizes own and workload of project team members
Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology
Knowledge/understanding of clinical development guidelines and directives
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel.
Preferred
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
