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. Coordinates SSU specialist across their regions
• May oversee site activation for assigned projects according to timelines and quality standard. Ensures that all sites within their regions are on track with critical path site activation plan
• Serves as an escalation point for issues identified by SSU specialist which can lead to delays in activation: regulatory issues and vendor set up related issues. Assist with coordination of the flow of information between PPD teams, clients, or functional departments involved in site activation.
• Works with other Regional/Oversight Leads to resolve issues/escalations to ensure activation activity occurs as per agreed plan.
• Where CAS is not available May oversee site activation according to timelines and quality standards
• Develop recommended plans/guidelines for project implementation using PPD tools
• Monitor and analyse 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.
• Review for quality and completeness EC submission packages for countries in their regions
• Accountable for regional and country start up specific metrics in Biogen systems – eg ensuring audit and inspection ready at all times
• Manages country and site Informed Consent Form (ICF) timelines and review and approve master and country ICFs
• 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.
• Oversee SSU Specialists to ensure site readiness follows baseline
• Vendor readiness, Training

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic
• 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 or a clinical environment.
• Exposure to electrical office equipment.
• 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.
• 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.

Apply today to help us deliver tomorrow’s breakthrough.