Start-up Manager, FSP

NCBioImpact; North Carolina; Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

Thermo Fisher Scientific is seeking a Start-up Team Manager to lead complex site activation for clinical studies. You will ensure regulatory compliance, support recruitment and training, and facilitate collaboration between trial sites and internal teams to drive study success.

In this role you will coordinate with multiple functions in a matrix environment, monitor project status, manage risks and contracts, and align resources with budgets to deliver on time.

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• 5+ years of experience in site activation or clinical operations.
• Ability to work cross-functionally in a matrix environment.
• Strong planning, organizational, and risk management skills.
• Knowledge of regulatory guidelines and trial conduct.

Responsabilités

• Coordinate site activation across projects to meet timelines and quality standards.
• Oversee site activation and ensure proper information flow between teams and clients.
• Develop implementation plans using PM tools and monitor progress with metrics.
• Identify risks, provide contingency plans, and manage budgets and contracts.
• Foster customer relationships and ensure adherence to budgets and scope.
• Collaborate with teams to ensure feasibility, contracts, and country coordination.

Connaissances

Project management

Cross-functional collaboration

Regulatory compliance

Clinical trials knowledge

Budget & contracting

Risk management

Communication skills

Formation

Bachelor's degree

Description du poste

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

What You’ll Do:

• 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.

Education and Experience:

• 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’).

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• 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

Working Conditions and Environment:

• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment is required such as protective eyewear, garments and gloves.
• Occasional travel, up to 20% of the time, includes travel to site locations both domestic and international. May include travel time outside of normal business hours and/or on weekends.

Physical Requirements:

• 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.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.