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:
Collaborates with team members to deliver effective site activation within assigned projects.
Coordinates SSU specialist across their regions
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.
Responsible for knowledge transfers across countries within regions
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.
Monitors project status, identifies risks, and provides metrics to upper management.
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 – ensuring audit and inspection ready at all times.
Performs risk identification, gap analysis and contingency planning for all countries within region
Manages country and site Informed Consent Form (ICF) timelines and review and approve master and country ICFs.
Manages financial and contractual aspects related to site activation.
Administers technical and operational aspects of site activation, including feasibility and contracts coordination
Oversee SSU Specilaists to ensure site readiness follows baseline
Work with SSU Oversight Lead to ensure that site activation readiness checker is aligned for each country
Collaborates with functional leads to address fundamental issues and implement solutions.
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.
Apply today to help us deliver tomorrow’s breakthrough.