Amendment Implementation Specialist

ThermoFisher Scientific; United States; Remote; COP 70,000,000 - 120,000,000; Full time

Job summary

Thermo Fisher Scientific is seeking an Associate Start-up Team Manager in Colombia to drive site activation and amendments within clinical studies. You will coordinate cross-functional teams, manage information flow between clients and internal departments, and help develop implementation plans to meet project timelines and budgets.

The role requires a Bachelor's degree or equivalent and 2+ years of relevant experience, with travel up to 20% and a focus on risk management and quality

Qualifications

• 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).
• 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.

Responsibilities

• Collaborate with multiple team members in a matrix environment for the effective delivery of site activation or amendments within assigned projects.
• Assist with the coordination of the flow of information between internal teams, clients, or functional departments involved in site activation or amendments.
• Participate in developing plans and guidelines for project implementation.
• Monitor and analyze project status to ensure successful progress and completion of all assigned projects, and provide metrics and status updates to senior team members and/or upper management.
• Perform risk identification and contingency planning.
• Collaborate with senior team members to manage financial and contractual aspects of the studies related to site activation or amendments.
• Participate in establishing appropriate controls to ensure that project resources and expenses are aligned with budgets.

Skills

Cross-functional PM

Stakeholder management

Budgeting

Risk assessment

Communication

Education

Bachelor's degree or equivalent

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Associate Start-up Team Manager – Make an Impact at the Forefront of Innovation

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

The Associate Start-up Team Manager completes site activation or amendment deliverables within the assigned projects and ensures all project deliverables meet customer expectations, as well as, contracted deliverables by providing accurate projections, report updates, and ongoing risk assessments.

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

What You'll Do:

• Collaborate with multiple team members in a matrix environment for the effective delivery of site activation or amendments within assigned projects.
• Assist with the coordination of the flow of information between internal teams, clients, or functional departments involved in site activation or amendments.
• Participate in developing plans and guidelines for project implementation.
• Monitor and analyze project status to ensure successful progress and completion of all assigned projects, and provide metrics and status updates to senior team members and/or upper management.
• Perform risk identification and contingency planning.
• Collaborate with senior team members to manage financial and contractual aspects of the studies related to site activation or amendments.
• Participate in establishing appropriate controls to ensure that project resources and expenses are aligned with budgets.

Education and Experience Requirements:

• 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).
• 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, Abilities:

• Able to work well and efficiently with cross-functional teams
• Consistently demonstrates knowledge of the key principles of cross-functional project management
• Solid organizational and multitasking skills
• Strong attention to detail
• Ability to identify and remedy risks related to contractual deliverables and provides appropriate
• Demonstrates basic understanding of cross-cultural awareness and is able to adapt appropriately
• Basic understanding and appreciation of clinical research/ development, including medical and
• Ability to lead, liaise and coordinate cross-functional project teams
• Firm knowledge/understanding of clinical development guidelines and directive

solutions

therapeutic areas, phases and medical terminology

Working Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• 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 required such as protective eyewear, garments and gloves.
• Occasional travel, up to 20% of the time, including travel to site locations both domestic and international. May include travel time outside of normal business hours and/or on weekends.
• May include travel time outside of normal business hours and/or on weekends.

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.