Start Up Team Manager, FSP

Thermo Fisher Scientific•Morrisville, NC

3d•Remote

About The Position

As the Start-up Team Manager at Thermo Fisher Scientific, you will play a pivotal role in site activation & manage complex site operations; ensure compliance with regulatory standards. In addition, this individual will be responsible for: supporting 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

Effective collaboration with cross-functional teams.
Knowledge of key principles of cross-functional project management.
Strong organizational and multitasking skills.
Attention to detail.
Ability to identify and mitigate risks related to contractual deliverables.
Cross-cultural awareness and adaptability.
Comprehensive understanding of clinical research and development, including medical and therapeutic areas, phases, and terminology.
Ability to lead, liaise, and coordinate cross-functional project teams.
Knowledge of clinical development guidelines and directives.
Bachelor's Degree
Must have previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 5+ years SSU experience has been in: CRO, Pharma organizations, highly preferred
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.

Responsibilities

Collaborate with team members to ensure effective site activation within assigned studies.
Coordinate SSU specialists across regions.
Ensure sites within their specific region are on track with the critical path site activation plan.
Serve as an escalation point for issues identified by SSU specialists, including regulatory and vendor setup issues.
Facilitate knowledge transfer across countries within regions.
Work with other Regional/Oversight Leads to resolve issues and ensure activation activities adhere to the agreed plan.
Oversee site activation according to timelines and quality standards within their specific region.
Assist with information flow between key stakeholders involved in site activation.
Oversee EC submission strategy and required documents (e.g., patient material, insurance certificates).
Provide quality checks for EC submission packages for both central and local ECs.
Manage technical and operational aspects, including feasibility, site selection, contracts coordination, and EC/RA submissions.
Ensure operational readiness for site activation in collaboration with CML (e.g., site binders, ancillary supplies, lab kits, training, system access).
Monitor regional study status, identify risks, and provide metrics to Study Start-up (SSU) Oversight Lead.
Maintain metrics and tracking tools for regional startup activity.
Perform risk identification and contingency planning, participate in risk escalation meetings as required, and collaborate with study team to address issues and implement solutions for countries and sites in region.
Manage country and site Informed Consent Form (ICF) timelines; review and approve country ICFs.
Provide performance feedback to People Manager and support staff learning opportunities.
Utilize problem-solving techniques in a changing environment.
Prepare for and participate in country level meetings.
Oversee and manage the clinical trial insurance local policy country set-up for region.
Oversee and manage amendment implementation as needed.