Start-up Team Manager - FSP

Thermo Fisher Scientific • Morrisville, NC

3d • Remote

About The Position

Join us as Start-up Team Manager - To manage complex site operations, ensure compliance with regulatory standards, support site recruitment and training efforts, and facilitate smooth collaboration between trial sites and internal teams to drive the success of clinical studies. This individual is responsible for managing effective delivery of site activation within their assigned region(s). This role involves overseeing site activation according to timelines and quality standards, coordinating with others on a cross functional level, and managing technical and operational aspects.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 5+ years’)
• Able to work well and efficiently with cross-functional teams
• Consistently demonstrates knowledge of the key principles of cross functional project management
• Demonstrated organizational and multitasking skills
• Demonstrated attention to detail
• Ability to identify and remedy risks related to contractual deliverables and provides appropriate solutions
• Demonstrates sound understanding of cross-cultural awareness and can adapt appropriately
• Comprehensive understanding and appreciation of clinical research/ development, including medical and therapeutic areas, phases and medical terminology
• Demonstrates ability to lead, liaise and coordinate cross-functional project teams
• Comprehensive knowledge/understanding of clinical development guidelines and Directives
• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
• Ability to perform under stress.
• Ability to multi-task.
• Regular and consistent attendance.

Nice To Haves

• start-up experience in CRO/Pharma setting
• site experience
• ICF iteration/creation experience

Responsibilities

• Collaborate with multiple team members in a matrix environment for the effective delivery of site activation within the assigned projects.
• May oversee site activation for assigned projects according to timelines and quality standard.
• Assist with coordination of the flow of information between PPD teams, clients, or functional departments involved in site activation.
• Develop recommended plans/guidelines for project implementation using PPD tools.
• Monitor and analyze project status to ensure successful progress and completion of all assigned projects and provide metrics to upper management.
• Perform risk identification and provide contingency planning.
• Collaborate with PPD teams to manage all financial and contractual aspects of studies related to site activation.
• Work within the team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets with accountability to Global Project Management.
• Administer the technical and operational aspects of the site activation portion of assigned projects, including coordination of feasibility, site contracts, and country teams in a matrix environment and manages the assigned scope of work against timelines, costs, and quality.
• Participating in a functional area leads to identifying and evaluating fundamental issues pertaining to successful site activation, interpreting data on complex issues, make good business decisions and ensure solutions are implemented.
• Develop customer relationships in alignment with assigned projects.

Benefits

• Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager